<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/NCT02988791</url>
  </required_header>
  <id_info>
    <org_study_id>250</org_study_id>
    <nct_id>NCT02988791</nct_id>
  </id_info>
  <brief_title>Evaluation of a Probiotic (Bifidobacterium in the Treatment of Infantile Colic (IC)</brief_title>
  <official_title>Randomized Clinical Trial to Evaluate the Efficacy of Bifidobacterium in the Treatment of Infantile Colic (IC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federico II University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>SOFAR S.p.A.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Federico II University</source>
  <brief_summary>
    <textblock>
      Infantile colic (IC) criteria includes all of the following in subjects aged ≤ 4 months:&#xD;
      paroxysms of irritability, fussing, or crying that start and stop without obvious cause;&#xD;
      episodes lasting 3 or more hours per day and occurring at least 3 days per week for at least&#xD;
      1 week; and no failure to thrive. The condition is very common in the first 4 months of life&#xD;
      (10-30 % of infants) with a peak prevalence at 6-8 weeks and is characterized by excessive&#xD;
      and inconsolable crying without an identifiable cause. Infantile colic cause considerable&#xD;
      stress for the baby and the family, huge medical expenses (the IC cause 10-20 % of all&#xD;
      pediatric visits in the first 4 months of life) and frequent formula changes.&#xD;
&#xD;
      The pathophysiology of IC is still poorly defined, but differences in gut microbiota&#xD;
      composition seem to be involved. In particular, differences in the number and species of&#xD;
      Lactobacilli spp, Klebsiella spp and Escherichia coli spp have been demonstrated in subjects&#xD;
      with IC, and it has been postulated that these alterations could be responsible for an&#xD;
      abnormal gas production within gut lumen resulting in distension and abdominal pain. These&#xD;
      findings suggest the potential role of probiotics as preventive and therapeutic strategy for&#xD;
      the IC.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">September 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>mean daily crying duration</measure>
    <time_frame>up to 28 days</time_frame>
    <description>reduction of ≥50% of mean daily crying duration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of regurgitation</measure>
    <time_frame>up to 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the gut microbiota modifications</measure>
    <time_frame>up to 28 days</time_frame>
    <description>Stool sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fecal production of peptides from innate immune system</measure>
    <time_frame>up to 28 days</time_frame>
    <description>Stool sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fecal short chain fatty acids production</measure>
    <time_frame>28 days</time_frame>
    <description>Stool sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>evacuative frequency</measure>
    <time_frame>up to 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>consistency of the fecal mass</measure>
    <time_frame>up to 28 days</time_frame>
    <description>assessed by means of Bristol score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of crying episode</measure>
    <time_frame>up to 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sleep</measure>
    <time_frame>up to 28 days</time_frame>
    <description>duration of sleep</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Infantile Colic</condition>
  <arm_group>
    <arm_group_label>Probiotic (Bifidobacterium)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active, Bifidobacterium BB12</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>probiotic (BIfidobacterium, BB-12®)</intervention_name>
    <description>probiotic (Bifidobacterium, BB-12®)</description>
    <arm_group_label>Probiotic (Bifidobacterium)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  exclusively breastfed healthy infants of both sex, aged ≤ 7 weeks;&#xD;
&#xD;
          -  Diagnosis of IC according to Rome III criteria&#xD;
&#xD;
          -  Written informed consent of the parent/tutor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Birth weight&lt;2500 g&#xD;
&#xD;
          -  Gestational age&lt;37 weeks&#xD;
&#xD;
          -  APGAR 5 minutes &lt;7&#xD;
&#xD;
          -  Formula feeding&#xD;
&#xD;
          -  Abnormal body growth/loss of weight (&lt;100 g/weeks from birth to the last reported&#xD;
             weight)&#xD;
&#xD;
          -  Neurological diseases&#xD;
&#xD;
          -  Known or suspected food allergy&#xD;
&#xD;
          -  Gastroesophageal reflux disease&#xD;
&#xD;
          -  Use of substances that alter gut microbiota (pre/pro/synbiotic, antibiotics, gastric&#xD;
             acidity inhibitors) or any anti-colic drug in the last 2 weeks prior the enrollment&#xD;
&#xD;
          -  History of fever and/or infectious diseases in the last 2 weeks prior the enrollment&#xD;
&#xD;
          -  Ongoing systemic infections&#xD;
&#xD;
          -  History of congenital infections&#xD;
&#xD;
          -  Chronic intestinal diseases (cystic fibrosis or other forms of pancreatic&#xD;
             insufficiency primitive)&#xD;
&#xD;
          -  Malformation of the gastrointestinal (such as esophageal atresia, intestinal atresia,&#xD;
             short bowel syndrome, malrotation), urinary or respiratory tract&#xD;
&#xD;
          -  Metabolic diseases&#xD;
&#xD;
          -  Genetic diseases and chromosomal abnormalities&#xD;
&#xD;
          -  Primary or secondary immunodeficiencies&#xD;
&#xD;
          -  Not sufficient reliability or presence of conditions that may result in&#xD;
             non-compliance/adherence of the patient to the Protocol&#xD;
&#xD;
          -  Previous participation in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Week</minimum_age>
    <maximum_age>7 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Naples Federico II</name>
      <address>
        <city>Naples</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>April 11, 2019</last_update_submitted>
  <last_update_submitted_qc>April 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federico II University</investigator_affiliation>
    <investigator_full_name>Roberto Berni Canani</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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/NCT02988791
org study id: 250
nct id: NCT02988791
lead sponsor: 
collaborator: 
Infantile colic (IC) criteria includes all of the following in subjects aged ≤ 4 months:
      paroxysms of irritability, fussing, or crying that start and stop without obvious cause;
      episodes lasting 3 or more hours per day and occurring at least 3 days per week for at least
      1 week; and no failure to thrive. The condition is very common in the first 4 months of life
      (10-30 % of infants) with a peak prevalence at 6-8 weeks and is characterized by excessive
      and inconsolable crying without an identifiable cause. Infantile colic cause considerable
      stress for the baby and the family, huge medical expenses (the IC cause 10-20 % of all
      pediatric visits in the first 4 months of life) and frequent formula changes.

      The pathophysiology of IC is still poorly defined, but differences in gut microbiota
      composition seem to be involved. In particular, differences in the number and species of
      Lactobacilli spp, Klebsiella spp and Escherichia coli spp have been demonstrated in subjects
      with IC, and it has been postulated that these alterations could be responsible for an
      abnormal gas production within gut lumen resulting in distension and abdominal pain. These
      findings suggest the potential role of probiotics as preventive and therapeutic strategy for
      the IC.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: mean daily crying duration
time frame: up to 28 days
description: reduction of ≥50% of mean daily crying duration
measure: number of regurgitation
time frame: up to 28 days
measure: Evaluation of the gut microbiota modifications
time frame: up to 28 days
description: Stool sample
measure: fecal production of peptides from innate immune system
time frame: up to 28 days
description: Stool sample
measure: fecal short chain fatty acids production
time frame: 28 days
description: Stool sample
measure: evacuative frequency
time frame: up to 28 days
measure: consistency of the fecal mass
time frame: up to 28 days
description: assessed by means of Bristol score
measure: number of crying episode
time frame: up to 28 days
measure: sleep
time frame: up to 28 days
description: duration of sleep
arm group label: Probiotic (Bifidobacterium)
arm group type: Experimental
description: Active, Bifidobacterium BB12
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Dietary Supplement
intervention name: probiotic (BIfidobacterium, BB-12®)
description: probiotic (Bifidobacterium, BB-12®)
arm group label: Probiotic (Bifidobacterium)
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 1 Week
maximum age: 7 Weeks
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Federico II University
investigator full name: Roberto Berni Canani
investigator title: Principal Investigator
mesh term: Colic