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

NCT02988791 | Completed

• 1 other identifier: 250
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Infantile Colic

Outcome Measures

Primary Outcomes (1)

• mean daily crying duration

  reduction of ≥50% of mean daily crying duration

  up to 28 days

Secondary Outcomes (8)

• number of regurgitation

  up to 28 days

• Evaluation of the gut microbiota modifications

  up to 28 days

• fecal production of peptides from innate immune system

  up to 28 days

• fecal short chain fatty acids production

  28 days

• evacuative frequency

  up to 28 days

Study Arms (2)

Probiotic (Bifidobacterium)

EXPERIMENTAL

Active, Bifidobacterium BB12

Dietary Supplement: probiotic (BIfidobacterium, BB-12®)

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

probiotic (BIfidobacterium, BB-12®) DIETARY_SUPPLEMENT

probiotic (Bifidobacterium, BB-12®)

Probiotic (Bifidobacterium)

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 1 Week - 7 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead
• SOFAR S.p.A.: collaborator

Study Sites (1)

University of Naples Federico II

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Colic

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: December 9, 2016
• Study Start: November 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: May 1, 2018
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

IT (1)