Lactobacillus Reuteri Supplementation in the Treatment of Infantile Colic

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-09-30

Brief Summary

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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.

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Detailed Description

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NOTE: The study never started.

Conditions

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Infantile Colic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lactobacillus reteuri

Dietary Supplement: Lactobacillus reuteri DSM17938 probiotic 2 x 10(8) CFU/day 21 days

Group Type EXPERIMENTAL

Lactobacillus reuteri DSM17938 probiotic

Intervention Type DIETARY_SUPPLEMENT

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

Other: Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Drops suitable for infants. 2 X 5 drops / day will be issued, corresponding to the lipid emulsion without probiotics.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Drops suitable for infants. 2 X 5 drops / day will be issued, corresponding to the lipid emulsion without probiotics.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

29 Days

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No