<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02246010</url>
  </required_header>
  <id_info>
    <org_study_id>PED.MN.09</org_study_id>
    <nct_id>NCT02246010</nct_id>
  </id_info>
  <brief_title>Lactose-free Milk in Infants With Acute Diarrhea in a Developing Country</brief_title>
  <official_title>Does Intake of Lactose-free Milk in Infants With Acute Gastroenteritis in a Developing Country Shorten the Duration of Diarrhea? A Randomized Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>American University of Beirut Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>American University of Beirut Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether lactose-free milk will shorten the diarrhea&#xD;
      duration and decrease its severity in formula-fed infants presenting to the Emergency&#xD;
      Department (ED) or pediatric clinics with acute diarrhea.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acute gastroenteritis is a major cause of pediatric morbidity and mortality accounting for 15&#xD;
      % of all childhood death worldwide, and is a major public health burden, especially in&#xD;
      developing countries. A recent Cochrane review of 33 randomized or quasi-randomized trials&#xD;
      reported a modest reduction in the duration of diarrhea in children younger than 5 years who&#xD;
      were on reduced or lactose-free diet. Those trials however were conducted on inpatients in&#xD;
      high or middle-income countries. None were from developing countries where diarrheal diseases&#xD;
      are severer and result in higher morbidities and mortalities. This study aims at&#xD;
      investigating the effect of lactose-free milk on the duration and severity of diarrhea in&#xD;
      infants from a developing country, who present with acute gastroenteritis to the Emergency&#xD;
      Department (ED) or pediatric clinics. The findings from this study will help provide&#xD;
      evidence-based dietary recommendations for infants with acute diarrhea in developing&#xD;
      countries who are treated in the ambulatory setting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Very slow recruitment rate. Only 6 infants were recruited over 2 years.&#xD;
  </why_stopped>
  <start_date type="Actual">July 1, 2015</start_date>
  <completion_date type="Actual">June 30, 2017</completion_date>
  <primary_completion_date type="Actual">June 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diarrhea Duration</measure>
    <time_frame>From onset of illness till the day of last diarrheic stool passed.</time_frame>
    <description>number of days with 3 or more loose or watery stools</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight Loss</measure>
    <time_frame>7 days</time_frame>
    <description>Percent weight loss from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Illness Visits</measure>
    <time_frame>7 days</time_frame>
    <description>Number of participants with illness visits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization Rate</measure>
    <time_frame>7 days</time_frame>
    <description>Rate of hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parental Satisfaction</measure>
    <time_frame>7 days</time_frame>
    <description>Parental satisfaction with treatment on a Likert scale from 0 (not satisfied) to 10 (very satisfied).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Acute Gastroenteritis</condition>
  <arm_group>
    <arm_group_label>Lactose-free milk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Regular infant milk</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Regular infant milk formula and anti-diarrheic diet for 7 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lactose- free milk</intervention_name>
    <description>Lactose- free milk</description>
    <arm_group_label>Lactose-free milk</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants on artificial milk formula&#xD;
&#xD;
          -  Presenting to the ED or pediatric clinics of the American University of Beirut Medical&#xD;
             Center&#xD;
&#xD;
          -  Chief complaint: acute gastroenteritis (three or more loose or liquid stools in 24&#xD;
             hours, for at least 24 hours, and not exceeding 2 weeks from presentation, with or&#xD;
             without fever, vomiting, mucus or blood per stools).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusively or partially breast-fed infants&#xD;
&#xD;
          -  Severe dehydration requiring hospitalization&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Months</minimum_age>
    <maximum_age>18 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>American University of Beirut Medical Center</name>
      <address>
        <city>Beirut</city>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Lebanon</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <results_first_submitted>January 24, 2018</results_first_submitted>
  <results_first_submitted_qc>January 24, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">January 25, 2019</results_first_posted>
  <last_update_submitted>January 25, 2019</last_update_submitted>
  <last_update_submitted_qc>January 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>American University of Beirut Medical Center</investigator_affiliation>
    <investigator_full_name>Mona Nabulsi</investigator_full_name>
    <investigator_title>Professor of Clinical Pediatrics</investigator_title>
  </responsible_party>
  <keyword>diarrhea</keyword>
  <keyword>developing world</keyword>
  <keyword>lactose-free diet</keyword>
  <keyword>Clinical trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroenteritis</mesh_term>
    <mesh_term>Diarrhea</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 23, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT02246010/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Lactose-free Milk</title>
          <description>Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days.&#xD;
Lactose- free milk: Lactose- free milk</description>
        </group>
        <group group_id="P2">
          <title>Regular Infant Milk</title>
          <description>Regular infant milk formula and anti-diarrheic diet for 7 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Infants between 2 months and 18 months presenting with acute diarrhea.</population>
      <group_list>
        <group group_id="B1">
          <title>Lactose-free Milk</title>
          <description>Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days.</description>
        </group>
        <group group_id="B2">
          <title>Regular Infant Milk</title>
          <description>Regular infant milk formula and anti-diarrheic diet for 7 days.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="4"/>
            <count group_id="B2" value="2"/>
            <count group_id="B3" value="6"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Less than 6 months</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Equal or more than 6 months</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diarrhea duration</title>
          <description>Number of days with diarrhea.</description>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.2" spread="2.2"/>
                    <measurement group_id="B2" value="3.5" spread="0.7"/>
                    <measurement group_id="B3" value="4.0" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Diarrhea Duration</title>
        <description>number of days with 3 or more loose or watery stools</description>
        <time_frame>From onset of illness till the day of last diarrheic stool passed.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lactose-free Milk</title>
            <description>Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days.&#xD;
Lactose- free milk: Lactose- free milk</description>
          </group>
          <group group_id="O2">
            <title>Regular Infant Milk</title>
            <description>Regular infant milk formula and anti-diarrheic diet for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Diarrhea Duration</title>
          <description>number of days with 3 or more loose or watery stools</description>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7" spread="2.2"/>
                    <measurement group_id="O2" value="8.5" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Weight Loss</title>
        <description>Percent weight loss from baseline</description>
        <time_frame>7 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lactose-free Milk</title>
            <description>Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days.&#xD;
Lactose- free milk: Lactose- free milk</description>
          </group>
          <group group_id="O2">
            <title>Regular Infant Milk</title>
            <description>Regular infant milk formula and anti-diarrheic diet for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Weight Loss</title>
          <description>Percent weight loss from baseline</description>
          <units>percent of body weight in kilogram</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" spread="0.2"/>
                    <measurement group_id="O2" value="2.5" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Illness Visits</title>
        <description>Number of participants with illness visits</description>
        <time_frame>7 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lactose-free Milk</title>
            <description>Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days.&#xD;
Lactose- free milk: Lactose- free milk</description>
          </group>
          <group group_id="O2">
            <title>Regular Infant Milk</title>
            <description>Regular infant milk formula and anti-diarrheic diet for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Illness Visits</title>
          <description>Number of participants with illness visits</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospitalization Rate</title>
        <description>Rate of hospitalization</description>
        <time_frame>7 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lactose-free Milk</title>
            <description>Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days.&#xD;
Lactose- free milk: Lactose- free milk</description>
          </group>
          <group group_id="O2">
            <title>Regular Infant Milk</title>
            <description>Regular infant milk formula and anti-diarrheic diet for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospitalization Rate</title>
          <description>Rate of hospitalization</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parental Satisfaction</title>
        <description>Parental satisfaction with treatment on a Likert scale from 0 (not satisfied) to 10 (very satisfied).</description>
        <time_frame>7 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lactose-free Milk</title>
            <description>Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days.&#xD;
Lactose- free milk: Lactose- free milk</description>
          </group>
          <group group_id="O2">
            <title>Regular Infant Milk</title>
            <description>Regular infant milk formula and anti-diarrheic diet for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Parental Satisfaction</title>
          <description>Parental satisfaction with treatment on a Likert scale from 0 (not satisfied) to 10 (very satisfied).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7" spread="0.6"/>
                    <measurement group_id="O2" value="9.5" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Within 7 days from enrollment.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Lactose-free Milk</title>
          <description>Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days.&#xD;
Lactose- free milk: Lactose- free milk</description>
        </group>
        <group group_id="E2">
          <title>Regular Infant Milk</title>
          <description>Regular infant milk formula and anti-diarrheic diet for 7 days.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Mona Nabulsi</name_or_title>
      <organization>American University of Beirut</organization>
      <phone>9611350000 ext 5523</phone>
      <email>mn04@aub.edu.lb</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02246010
org study id: PED.MN.09
nct id: NCT02246010
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether lactose-free milk will shorten the diarrhea
      duration and decrease its severity in formula-fed infants presenting to the Emergency
      Department (ED) or pediatric clinics with acute diarrhea.
Acute gastroenteritis is a major cause of pediatric morbidity and mortality accounting for 15
      % of all childhood death worldwide, and is a major public health burden, especially in
      developing countries. A recent Cochrane review of 33 randomized or quasi-randomized trials
      reported a modest reduction in the duration of diarrhea in children younger than 5 years who
      were on reduced or lactose-free diet. Those trials however were conducted on inpatients in
      high or middle-income countries. None were from developing countries where diarrheal diseases
      are severer and result in higher morbidities and mortalities. This study aims at
      investigating the effect of lactose-free milk on the duration and severity of diarrhea in
      infants from a developing country, who present with acute gastroenteritis to the Emergency
      Department (ED) or pediatric clinics. The findings from this study will help provide
      evidence-based dietary recommendations for infants with acute diarrhea in developing
      countries who are treated in the ambulatory setting.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Diarrhea Duration
time frame: From onset of illness till the day of last diarrheic stool passed.
description: number of days with 3 or more loose or watery stools
measure: Weight Loss
time frame: 7 days
description: Percent weight loss from baseline
measure: Illness Visits
time frame: 7 days
description: Number of participants with illness visits
measure: Hospitalization Rate
time frame: 7 days
description: Rate of hospitalization
measure: Parental Satisfaction
time frame: 7 days
description: Parental satisfaction with treatment on a Likert scale from 0 (not satisfied) to 10 (very satisfied).
arm group label: Lactose-free milk
arm group type: Experimental
description: Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days.
arm group label: Regular infant milk
arm group type: No Intervention
description: Regular infant milk formula and anti-diarrheic diet for 7 days.
intervention type: Dietary Supplement
intervention name: Lactose- free milk
description: Lactose- free milk
arm group label: Lactose-free milk
criteria: 
gender: All
minimum age: 2 Months
maximum age: 18 Months
healthy volunteers: No
facility: 
country: Lebanon
responsible party type: Principal Investigator
investigator affiliation: American University of Beirut Medical Center
investigator full name: Mona Nabulsi
investigator title: Professor of Clinical Pediatrics
mesh term: Gastroenteritis
mesh term: Diarrhea
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 