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

Randomized Clinical Trial to Evaluate the Efficacy of Bifidobacterium in the Treatment of Infantile Colic (IC)

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.

Study Overview

• Status: Completed
• Conditions: Infantile Colic
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: probiotic (BIfidobacterium, BB-12®)

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • University of Naples Federico II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Placebo
Experimental: Probiotic (Bifidobacterium); Active, Bifidobacterium BB12	Dietary supplement: probiotic (BIfidobacterium, BB-12®); probiotic (Bifidobacterium, BB-12®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean daily crying duration	reduction of ≥50% of mean daily crying duration	up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of regurgitation		up to 28 days
Evaluation of the gut microbiota modifications	Stool sample	up to 28 days
fecal production of peptides from innate immune system	Stool sample	up to 28 days
fecal short chain fatty acids production	Stool sample	28 days
evacuative frequency		up to 28 days
consistency of the fecal mass	assessed by means of Bristol score	up to 28 days
number of crying episode		up to 28 days
sleep	duration of sleep	up to 28 days

Collaborators and Investigators

• Sponsor: Federico II University
• Collaborators: SOFAR S.p.A.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: November 14, 2016
• First Submitted That Met QC Criteria: December 7, 2016
• First Posted (Estimate): December 9, 2016

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 11, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Colic
• Other Study ID Numbers: 250

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No