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Evaluation of a Probiotic (Bifidobacterium in the Treatment of Infantile Colic (IC)

Primary Purpose

Infantile Colic

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
probiotic (BIfidobacterium, BB-12®)
Placebo
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infantile Colic

Eligibility Criteria

1 Week - 7 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • exclusively breastfed healthy infants of both sex, aged ≤ 7 weeks;
  • Diagnosis of IC according to Rome III criteria
  • Written informed consent of the parent/tutor

Exclusion Criteria:

  • Birth weight<2500 g
  • Gestational age<37 weeks
  • APGAR 5 minutes <7
  • Formula feeding
  • Abnormal body growth/loss of weight (<100 g/weeks from birth to the last reported weight)
  • Neurological diseases
  • Known or suspected food allergy
  • Gastroesophageal reflux disease
  • Use of substances that alter gut microbiota (pre/pro/synbiotic, antibiotics, gastric acidity inhibitors) or any anti-colic drug in the last 2 weeks prior the enrollment
  • History of fever and/or infectious diseases in the last 2 weeks prior the enrollment
  • Ongoing systemic infections
  • History of congenital infections
  • Chronic intestinal diseases (cystic fibrosis or other forms of pancreatic insufficiency primitive)
  • Malformation of the gastrointestinal (such as esophageal atresia, intestinal atresia, short bowel syndrome, malrotation), urinary or respiratory tract
  • Metabolic diseases
  • Genetic diseases and chromosomal abnormalities
  • Primary or secondary immunodeficiencies
  • Not sufficient reliability or presence of conditions that may result in non-compliance/adherence of the patient to the Protocol
  • Previous participation in this study

Sites / Locations

  • University of Naples Federico II

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic (Bifidobacterium)

Placebo

Arm Description

Active, Bifidobacterium BB12

Placebo

Outcomes

Primary Outcome Measures

mean daily crying duration
reduction of ≥50% of mean daily crying duration

Secondary Outcome Measures

number of regurgitation
Evaluation of the gut microbiota modifications
Stool sample
fecal production of peptides from innate immune system
Stool sample
fecal short chain fatty acids production
Stool sample
evacuative frequency
consistency of the fecal mass
assessed by means of Bristol score
number of crying episode
sleep
duration of sleep

Full Information

First Posted
November 14, 2016
Last Updated
April 11, 2019
Sponsor
Federico II University
Collaborators
SOFAR S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT02988791
Brief Title
Evaluation of a Probiotic (Bifidobacterium in the Treatment of Infantile Colic (IC)
Official Title
Randomized Clinical Trial to Evaluate the Efficacy of Bifidobacterium in the Treatment of Infantile Colic (IC)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
Collaborators
SOFAR S.p.A.

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infantile Colic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic (Bifidobacterium)
Arm Type
Experimental
Arm Description
Active, Bifidobacterium BB12
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
probiotic (BIfidobacterium, BB-12®)
Intervention Description
probiotic (Bifidobacterium, BB-12®)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
mean daily crying duration
Description
reduction of ≥50% of mean daily crying duration
Time Frame
up to 28 days
Secondary Outcome Measure Information:
Title
number of regurgitation
Time Frame
up to 28 days
Title
Evaluation of the gut microbiota modifications
Description
Stool sample
Time Frame
up to 28 days
Title
fecal production of peptides from innate immune system
Description
Stool sample
Time Frame
up to 28 days
Title
fecal short chain fatty acids production
Description
Stool sample
Time Frame
28 days
Title
evacuative frequency
Time Frame
up to 28 days
Title
consistency of the fecal mass
Description
assessed by means of Bristol score
Time Frame
up to 28 days
Title
number of crying episode
Time Frame
up to 28 days
Title
sleep
Description
duration of sleep
Time Frame
up to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Week
Maximum Age & Unit of Time
7 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: exclusively breastfed healthy infants of both sex, aged ≤ 7 weeks; Diagnosis of IC according to Rome III criteria Written informed consent of the parent/tutor Exclusion Criteria: Birth weight<2500 g Gestational age<37 weeks APGAR 5 minutes <7 Formula feeding Abnormal body growth/loss of weight (<100 g/weeks from birth to the last reported weight) Neurological diseases Known or suspected food allergy Gastroesophageal reflux disease Use of substances that alter gut microbiota (pre/pro/synbiotic, antibiotics, gastric acidity inhibitors) or any anti-colic drug in the last 2 weeks prior the enrollment History of fever and/or infectious diseases in the last 2 weeks prior the enrollment Ongoing systemic infections History of congenital infections Chronic intestinal diseases (cystic fibrosis or other forms of pancreatic insufficiency primitive) Malformation of the gastrointestinal (such as esophageal atresia, intestinal atresia, short bowel syndrome, malrotation), urinary or respiratory tract Metabolic diseases Genetic diseases and chromosomal abnormalities Primary or secondary immunodeficiencies Not sufficient reliability or presence of conditions that may result in non-compliance/adherence of the patient to the Protocol Previous participation in this study
Facility Information:
Facility Name
University of Naples Federico II
City
Naples
ZIP/Postal Code
80131
Country
Italy

12. IPD Sharing Statement

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Evaluation of a Probiotic (Bifidobacterium in the Treatment of Infantile Colic (IC)

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