Lactobacillus Reuteri Supplementation in the Treatment of Infantile Colic (PROBIOC)

The Benefit of Using the Lactobacillus Reuteri Probiotic as a Supplement in the Treatment of Newborn Colic

The purpose of this study is to evaluate the efficacy of the oral administration of Lactobacillus reuteri in treating infantile colic as defined by the Rome III criteria. Forty breastfed infants aged from 29 days to 3 months will be enrolled and blinded randomized to receive orally L.reuteri or placebo. The rate of responders (reduction of daily crying time >50% compared to the baseline) will be assessed at day 7, day 14 and day 21 in both groups. The average daily crying time as well as the associated digestive symptoms will also be analyzed.

Study Overview

• Status: Withdrawn
• Conditions: Infantile Colic
• Intervention / Treatment: Dietary supplement: Lactobacillus reuteri DSM17938 probiotic; Other: Placebo

Detailed Description

NOTE: The study never started.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Créteil, France, 94010
    • CRC CHIC and ACTIV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 3 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Exclusively breastfed Infants
2. Infant aged of 29 days to 3 months
3. With a diagnosis of infantile colic as defined by the Rome III criteria
4. Birth at term and eutrophic (weight, height, head circumference)
5. Apgar score> 7 at 5 minutes
6. Consent to the study signed by the two parents.
7. Availability during the study period

Exclusion Criteria:

1. Associated severe chronic disease
2. Acute infectious disease
3. Personal or family first degree history of allergy to milk proteins
4. Several infants of the same family from a multiple pregnancy
5. Infants who received antibiotics one week prior to randomization
6. Infants who received probiotics one week prior to randomization
7. Mother who received antibiotics 1 week before randomization
8. Regular consumption of probiotics by the mother 1 week before randomization
9. Infants-included in another clinical study
10. Lack of insurance coverage by the french social security
11. Non exclusively breastfed infants

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lactobacillus reteuri; Dietary Supplement: Lactobacillus reuteri DSM17938 probiotic 2 x 10(8) CFU/day 21 days	Dietary supplement: Lactobacillus reuteri DSM17938 probiotic; Drops suitable for infants. 2 X 5 drops / day will be issued, corresponding to 2.108 CFU Lactobacillus reuteri living DSM17938. The probiotic is contained in a lipid emulsion.
PLACEBO_COMPARATOR: Placebo; Other: Placebo	Other: Placebo; Drops suitable for infants. 2 X 5 drops / day will be issued, corresponding to the lipid emulsion without probiotics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The responder rate (infants for whom daily crying time decreases by 50% compared to baseline, D0) at D7 in the probiotic group compared to placebo. The daily crying time will be sound recorded during 24 hours at D0 and D7.and expressed in minutes.	day 7

Secondary Outcome Measures

Outcome Measure	Time Frame
The responders rates at D14 and D21 in the probiotic group compared to the placebo group.	Day 14 and day 21

Other Outcome Measures

Outcome Measure	Time Frame
The average duration of crying in the probiotic group compared with the placebo group at D7, D14 and D21.	Day 7, 14 and 21
Gastrointestinal symptoms (constipation, diarrhea, flatulence) evaluated at each visit required by the protocol	day 7, 14 and 21

Collaborators and Investigators

• Sponsor: BioGaia AB
• Collaborators: Hopital Universitaire Robert-Debre; Association Clinique Thérapeutique Infantile du val de Marne; CRC CHI Creteil France

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ACTUAL): May 1, 2014
• Study Completion (ACTUAL): September 1, 2014

Study Registration Dates

• First Submitted: June 20, 2013
• First Submitted That Met QC Criteria: June 24, 2013
• First Posted (ESTIMATE): June 26, 2013

Study Record Updates

• Last Update Posted (ACTUAL): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Probiotics; Lactobacillus reuteri; Pediatric Gastroenterology
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Colic
• Other Study ID Numbers: 2013-A00163-42