Clinical trial NCT01887444: Lactobacillus Reuteri Supplementation in the Treatment of Infantile Colic
Official title: The Benefit of Using the Lactobacillus Reuteri Probiotic as a Supplement in the Treatment of Newborn Colic
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Infantile Colic
Keywords: Pediatric Gastroenterology
Probiotics
Lactobacillus reuteri
Lead sponsor: BioGaia AB
Sponsor class: INDUSTRY
Collaborators: name: CRC CHI Creteil France
name: Association Clinique Thérapeutique Infantile du val de Marne
name: Hopital Universitaire Robert-Debre
First posted: 2013-06-26
Enrollment: 0
Sex: ALL
Minimum age (years): 29
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: NOTE: The study never started.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: day 7
Secondary outcomes:
measure: The responders rates at D14 and D21 in the probiotic group compared to the placebo group.
timeFrame: Day 14 and day 21
Other outcomes:
measure: The average duration of crying in the probiotic group compared with the placebo group at D7, D14 and D21.
timeFrame: Day 7, 14 and 21
measure: Gastrointestinal symptoms (constipation, diarrhea, flatulence) evaluated at each visit required by the protocol
timeFrame: day 7, 14 and 21
Locations:
city: Créteil
country: France
facility: CRC CHIC and ACTIV
Study officials:
affiliation: Hopital Universitaire Robert-Debre
name: Marc Bellaiche, MD
role: PRINCIPAL_INVESTIGATOR
References: