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

Infantile Colic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02988791
• Other study ID #: 250
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: May 2018

Study information

• Verified date: April 2019
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 7 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Colic
• Infantile Colic

Intervention

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

Locations

Country	Name	City	State
Italy	University of Naples Federico II	Naples

Sponsors (2)

Lead Sponsor	Collaborator
Federico II University	SOFAR S.p.A.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean daily crying duration	reduction of =50% of mean daily crying duration	up to 28 days
Secondary	number of regurgitation		up to 28 days
Secondary	Evaluation of the gut microbiota modifications	Stool sample	up to 28 days
Secondary	fecal production of peptides from innate immune system	Stool sample	up to 28 days
Secondary	fecal short chain fatty acids production	Stool sample	28 days
Secondary	evacuative frequency		up to 28 days
Secondary	consistency of the fecal mass	assessed by means of Bristol score	up to 28 days
Secondary	number of crying episode		up to 28 days
Secondary	sleep	duration of sleep	up to 28 days