<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/NCT01721850</url>
  </required_header>
  <id_info>
    <org_study_id>HiPP-505092</org_study_id>
    <nct_id>NCT01721850</nct_id>
  </id_info>
  <brief_title>Evaluation of Safety and Efficacy of New Infant Formula in Infantile Colic</brief_title>
  <acronym>Coco</acronym>
  <official_title>Evaluation of the Safety and Efficacy of New Infant Formula and Its Effects on the Gastrointestinal Tolerance (Crying Time) in Infantile Colic: a Double-blind, Randomized, Controlled Intervention Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HiPP GmbH &amp; Co. Vertrieb KG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HiPP GmbH &amp; Co. Vertrieb KG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is conducted to examine the safety and efficacy of a new infant formula and its&#xD;
      effects on the gastrointestinal tolerance in infants suffering from colic.&#xD;
&#xD;
      Primary hypothesis to be tested is: an infant formula with optimized composition improves&#xD;
      colicky symptoms compared to a standard formula.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Trial insurance could not be prolonged any more and expired&#xD;
  </why_stopped>
  <start_date type="Actual">December 2011</start_date>
  <completion_date type="Actual">April 2019</completion_date>
  <primary_completion_date type="Actual">April 2019</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>daily total crying time</measure>
    <time_frame>28 days</time_frame>
    <description>evaluation of the difference in the average reduction of daily crying time after 28 days of intervention between treatment and control group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>growth parameters</measure>
    <time_frame>90 days</time_frame>
    <description>determination of body weight, length, head circumference</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tolerance evaluated by stool characteristics, gastrointestinal disorders and side effects</measure>
    <time_frame>28 days</time_frame>
    <description>stool characteristics: frequency, consistency and color; gastrointestinal disorders: regurgitation, obstipation; side effects: vomiting, diarrhea, skin reactions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>formula intake</measure>
    <time_frame>28 days</time_frame>
    <description>evaluation of average daily drinking amount and formula acceptance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intestinal microbiota</measure>
    <time_frame>0-28 days</time_frame>
    <description>evaluation of changes in the composition of the intestinal microbiota (Lactobacilli, Bifidobacteria, Coliforms) after intervention</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">169</enrollment>
  <condition>Infantile Colic</condition>
  <arm_group>
    <arm_group_label>control formula</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>infants are fed a commercial stage 1 infant formula during the first 4 months of life, according to protocol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>intervention formula 1 group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>infants are fed hydrolyzed infant formula containing pre- and probiotics during the first 4 months of life, according to protocol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>intervention formula 2 group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>infants are fed hydrolyzed infant formula containing pre- and probiotics during the first 4 months of life, according to protocol</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>control formula</intervention_name>
    <description>commercial stage 1 infant formula</description>
    <arm_group_label>control formula</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>intervention formula 1</intervention_name>
    <description>infant formula with hydrolyzed protein (type I) and pre- and probiotics</description>
    <arm_group_label>intervention formula 1 group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>intervention formula 2</intervention_name>
    <description>infant formula with hydrolyzed protein (type II) and pre- and probiotics</description>
    <arm_group_label>intervention formula 2 group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy term infants&#xD;
&#xD;
          -  Subjects appropriate for gestational age between 35 and 41 weeks&#xD;
&#xD;
          -  Subjects between 15-60 days old&#xD;
&#xD;
          -  Subjects with birth weight between 2500 and 4200 g and regular weight gain (≥150g /&#xD;
             week)&#xD;
&#xD;
          -  Diagnosis of infantile colic according to modified Wessel criteria (Crying episodes&#xD;
             lasting 3 or more hours/day and occurring at least 3 days/week for at least 1 week)&#xD;
&#xD;
          -  Subjects exclusively bottle-fed at study entrance&#xD;
&#xD;
          -  Day care of the child only by mother/father&#xD;
&#xD;
          -  Provide written informed consent in accordance with legal requirement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neonatal problems (respiratory distress, asphyxia, Hypoglycaemia, sepsis, NEC)&#xD;
&#xD;
          -  Clinical evidence of chronic illness or gastrointestinal disorders (GER,&#xD;
             gastroenteritis)&#xD;
&#xD;
          -  Assumption of any kind of medication (except vitamin D, vitamin K and fluoride&#xD;
             prophylaxis) during the week before the beginning of the study and during the study&#xD;
             period&#xD;
&#xD;
          -  Subjects receiving formula for special medical purposes&#xD;
&#xD;
          -  Exclusively breast-fed infants&#xD;
&#xD;
          -  Feeding of supplemental Pro- and/or Prebiotics two weeks prior to inclusion&#xD;
&#xD;
          -  Allergic diseases (manifest atopic dermatitis, cow's milk allergy)&#xD;
&#xD;
          -  Participation in any other clinical intervention&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Days</minimum_age>
    <maximum_age>60 Days</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Francesco Savino, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ospedale Infantile Regina Margherita, Dipartimento di Scienze Pediatriche e dell'Adolescenza.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pediatric Office</name>
      <address>
        <city>Düsseldorf</city>
        <zip>40223</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Office</name>
      <address>
        <city>Kehl</city>
        <zip>77694</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Office</name>
      <address>
        <city>Mülheim an der Ruhr</city>
        <zip>45475</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric office</name>
      <address>
        <city>Alba</city>
        <state>Piemonte</state>
        <zip>10141</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric office</name>
      <address>
        <city>Borgone</city>
        <state>Piemonte</state>
        <zip>10053</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric office</name>
      <address>
        <city>Carmagnola</city>
        <state>Piemonte</state>
        <zip>10022</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Office</name>
      <address>
        <city>Condove</city>
        <state>Piemonte</state>
        <zip>10055</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric office</name>
      <address>
        <city>Mondovi</city>
        <state>Piemonte</state>
        <zip>10090</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric office</name>
      <address>
        <city>San Mauro Torinese</city>
        <state>Piemonte</state>
        <zip>10099</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric office</name>
      <address>
        <city>Torino</city>
        <state>Piemonte</state>
        <zip>10124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric office</name>
      <address>
        <city>Torino</city>
        <state>Piemonte</state>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Office</name>
      <address>
        <city>Torino</city>
        <state>Piemonte</state>
        <zip>10132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Office</name>
      <address>
        <city>Torino</city>
        <state>Piemonte</state>
        <zip>10137</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric office</name>
      <address>
        <city>Torino</city>
        <state>Piemonte</state>
        <zip>10148</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric office</name>
      <address>
        <city>Torino</city>
        <state>Piemonte</state>
        <zip>10149</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric office</name>
      <address>
        <city>Turin</city>
        <state>Piemonte</state>
        <zip>10078</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Office</name>
      <address>
        <city>Volpiano</city>
        <state>Piemonte</state>
        <zip>10088</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Office</name>
      <address>
        <city>Volvera</city>
        <state>Piemonte</state>
        <zip>10040</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>January 4, 2022</last_update_submitted>
  <last_update_submitted_qc>January 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>infant nutrition, infantile colic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colic</mesh_term>
  </condition_browse>
  <!-- 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/NCT01721850
org study id: HiPP-505092
nct id: NCT01721850
lead sponsor: 
has dmc: No
The study is conducted to examine the safety and efficacy of a new infant formula and its
      effects on the gastrointestinal tolerance in infants suffering from colic.

      Primary hypothesis to be tested is: an infant formula with optimized composition improves
      colicky symptoms compared to a standard formula.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: daily total crying time
time frame: 28 days
description: evaluation of the difference in the average reduction of daily crying time after 28 days of intervention between treatment and control group
measure: growth parameters
time frame: 90 days
description: determination of body weight, length, head circumference
measure: tolerance evaluated by stool characteristics, gastrointestinal disorders and side effects
time frame: 28 days
description: stool characteristics: frequency, consistency and color; gastrointestinal disorders: regurgitation, obstipation; side effects: vomiting, diarrhea, skin reactions
measure: formula intake
time frame: 28 days
description: evaluation of average daily drinking amount and formula acceptance
measure: intestinal microbiota
time frame: 0-28 days
description: evaluation of changes in the composition of the intestinal microbiota (Lactobacilli, Bifidobacteria, Coliforms) after intervention
arm group label: control formula
arm group type: Active Comparator
description: infants are fed a commercial stage 1 infant formula during the first 4 months of life, according to protocol
arm group label: intervention formula 1 group
arm group type: Experimental
description: infants are fed hydrolyzed infant formula containing pre- and probiotics during the first 4 months of life, according to protocol
arm group label: intervention formula 2 group
arm group type: Experimental
description: infants are fed hydrolyzed infant formula containing pre- and probiotics during the first 4 months of life, according to protocol
intervention type: Other
intervention name: control formula
description: commercial stage 1 infant formula
arm group label: control formula
intervention type: Other
intervention name: intervention formula 1
description: infant formula with hydrolyzed protein (type I) and pre- and probiotics
arm group label: intervention formula 1 group
intervention type: Other
intervention name: intervention formula 2
description: infant formula with hydrolyzed protein (type II) and pre- and probiotics
arm group label: intervention formula 2 group
criteria: 
gender: All
minimum age: 15 Days
maximum age: 60 Days
healthy volunteers: Accepts Healthy Volunteers
last name: Francesco Savino, Dr.
role: Principal Investigator
affiliation: Ospedale Infantile Regina Margherita, Dipartimento di Scienze Pediatriche e dell'Adolescenza.
facility: 
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country: Germany
country: Italy
responsible party type: Sponsor
mesh term: Colic