<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/NCT02989350</url>
  </required_header>
  <id_info>
    <org_study_id>1/2016</org_study_id>
    <nct_id>NCT02989350</nct_id>
  </id_info>
  <brief_title>Efficacy of Lactobacillus Reuteri DSM 17938 for the Treatment of Acute Gastroenteritis in Children</brief_title>
  <official_title>Efficacy of Lactobacillus Reuteri DSM 17938 for the Treatment of Acute Gastroenteritis in Children: Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Szpital im. Św. Jadwigi Śląskiej</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Szpital im. Św. Jadwigi Śląskiej</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute gastroenteritis (AGE) is one of the most common diseases among children. Oral&#xD;
      rehydration therapy is the key treatment. According to the 2014 guidelines developed by the&#xD;
      ESPGHAN probiotics may be considered in the management of children with AGE in addition to&#xD;
      rehydration therapy. Considering that evidence on L reuteri remains limited, the&#xD;
      investigators aim to assess the efficacy of L reuteri DSM 17938 for the treatment of AGE in&#xD;
      children. Children vaccinated and not vaccinated against rotavirus will be evaluated&#xD;
      separately.&#xD;
&#xD;
      Two independent reports (rotavirus-vaccinated and non-vaccinated children) are planned.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 16, 2017</start_date>
  <completion_date type="Actual">November 2018</completion_date>
  <primary_completion_date type="Actual">November 2018</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of diarrhea</measure>
    <time_frame>8 days</time_frame>
    <description>(measured in hours) - time until the normalisation of stool consistency according to the Bristol Stool Form Scale(BSF) or Amsterdam Infant Stool Scale (ASF) - (in BSF scale, numbers 1, 2, 3, 4 and 5; in ASF scale, letters B or C), or the time until the normalisation of the number of stools (compared with the period before the onset of diarrhoea).and the presence of normal stools for 48 h.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Need for intravenous rehydration</measure>
    <time_frame>8 days</time_frame>
    <description>Number of patients in each group requiring intravenous rehydration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of intravenous rehydration</measure>
    <time_frame>8 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for hospitalisation of outpatients</measure>
    <time_frame>8 days</time_frame>
    <description>Number of patients enrolled as outpatient requiring hospitalisation - based on medical assesment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of watery stools per day</measure>
    <time_frame>8 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vomiting</measure>
    <time_frame>8 days</time_frame>
    <description>Number of participants with vomits and number of vomits per day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence of diarrhoea (in 48 hours after intervention)</measure>
    <time_frame>48 hours</time_frame>
    <description>Number of patients in which diarrhoea recur after initial recovery in 48 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of diarrhoea according to Vesikari scale</measure>
    <time_frame>8 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of concomitant medications</measure>
    <time_frame>8 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>8 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Acute Gastroenteritis</condition>
  <arm_group>
    <arm_group_label>Lactobacillus reuteri DSM 17938</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2 x 10(8) CFU. Both L reuteri DSM 17938 and placebo will be taken orally, twice daily 5 drops, for consecutive 5 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo consists of an identical formulation, except active substance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lactobacillus reuteri DSM 17938</intervention_name>
    <description>Lactobacillus reuteri DSM 17938 vs Placebo</description>
    <arm_group_label>Lactobacillus reuteri DSM 17938</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Lactobacillus reuteri DSM 17938 vs Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Acute gastroenteritis (AGE) defined as a change in stool consistency to loose or&#xD;
             liquid form (according to the Bristol Stool Form (BSF) scale or in the case of&#xD;
             infants, the Amsterdam Stool Form (ASF) scale) and/or an increase in the frequency of&#xD;
             evacuations (typically ≥3 in 24 h), lasting for no longer than 5 days.&#xD;
&#xD;
          2. Age: older than 1 month and younger than 60 months.&#xD;
&#xD;
          3. A caregiver must provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Use of antibiotics within two weeks prior to enrolment.&#xD;
&#xD;
          2. Use of gelatine tannate, diosmectite, probiotics, racecadotril, or zinc (including&#xD;
             zinc containing ORS) within a week prior to enrolment (a single dose is allowed).&#xD;
&#xD;
          3. Breast feeding (&gt;50%)&#xD;
&#xD;
          4. Chronic diarrhoeal gastrointestinal disease (e.g., inflammatory bowel disease, cystic&#xD;
             fibrosis, coeliac disease, food allergy)&#xD;
&#xD;
          5. Immunodeficiency&#xD;
&#xD;
          6. Malnutrition (weight/height/length under 3rd percentile) (WHO Child Growth Standards&#xD;
             will be used)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Months</minimum_age>
    <maximum_age>60 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Henryk Szymański, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Szpital im.Świętej Jadwigi Śląskiej, Trzebnica, Poland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Szpiatal im.Świętej Jadwigi Śląskiej</name>
      <address>
        <city>Trzebnica</city>
        <zip>55-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <link>
    <url>http://www.researchprotocols.org/2017/8/e164/</url>
    <description>published protocol</description>
  </link>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Szpital im. Św. Jadwigi Śląskiej</investigator_affiliation>
    <investigator_full_name>Henryk Szymański</investigator_full_name>
    <investigator_title>MD PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroenteritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02989350
org study id: 1/2016
nct id: NCT02989350
lead sponsor: 
has dmc: Yes
Acute gastroenteritis (AGE) is one of the most common diseases among children. Oral
      rehydration therapy is the key treatment. According to the 2014 guidelines developed by the
      ESPGHAN probiotics may be considered in the management of children with AGE in addition to
      rehydration therapy. Considering that evidence on L reuteri remains limited, the
      investigators aim to assess the efficacy of L reuteri DSM 17938 for the treatment of AGE in
      children. Children vaccinated and not vaccinated against rotavirus will be evaluated
      separately.

      Two independent reports (rotavirus-vaccinated and non-vaccinated children) are planned.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Duration of diarrhea
time frame: 8 days
description: (measured in hours) - time until the normalisation of stool consistency according to the Bristol Stool Form Scale(BSF) or Amsterdam Infant Stool Scale (ASF) - (in BSF scale, numbers 1, 2, 3, 4 and 5; in ASF scale, letters B or C), or the time until the normalisation of the number of stools (compared with the period before the onset of diarrhoea).and the presence of normal stools for 48 h.
measure: Need for intravenous rehydration
time frame: 8 days
description: Number of patients in each group requiring intravenous rehydration
measure: Duration of intravenous rehydration
time frame: 8 days
measure: Need for hospitalisation of outpatients
time frame: 8 days
description: Number of patients enrolled as outpatient requiring hospitalisation - based on medical assesment
measure: Number of watery stools per day
time frame: 8 days
measure: Vomiting
time frame: 8 days
description: Number of participants with vomits and number of vomits per day
measure: Recurrence of diarrhoea (in 48 hours after intervention)
time frame: 48 hours
description: Number of patients in which diarrhoea recur after initial recovery in 48 hours
measure: Severity of diarrhoea according to Vesikari scale
time frame: 8 days
measure: Use of concomitant medications
time frame: 8 days
measure: Adverse events
time frame: 8 days
arm group label: Lactobacillus reuteri DSM 17938
arm group type: Active Comparator
description: 2 x 10(8) CFU. Both L reuteri DSM 17938 and placebo will be taken orally, twice daily 5 drops, for consecutive 5 days.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo consists of an identical formulation, except active substance.
intervention type: Dietary Supplement
intervention name: Lactobacillus reuteri DSM 17938
description: Lactobacillus reuteri DSM 17938 vs Placebo
arm group label: Lactobacillus reuteri DSM 17938
intervention type: Dietary Supplement
intervention name: Placebo
description: Lactobacillus reuteri DSM 17938 vs Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 2 Months
maximum age: 60 Months
healthy volunteers: No
last name: Henryk Szymański, MD PhD
role: Principal Investigator
affiliation: Szpital im.Świętej Jadwigi Śląskiej, Trzebnica, Poland
facility: 
country: Poland
url: http://www.researchprotocols.org/2017/8/e164/
description: published protocol
responsible party type: Principal Investigator
investigator affiliation: Szpital im. Św. Jadwigi Śląskiej
investigator full name: Henryk Szymański
investigator title: MD PhD
mesh term: Gastroenteritis
sharing ipd: Undecided