Trial | NCT01887444  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Study Participants

    0
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.
NOTE: The study never started.
Study Started
Oct 31
2013
Primary Completion
May 31
2014
Study Completion
Sep 30
2014
Last Update
Feb 04
2021

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.

Other Placebo

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

Lactobacillus reteuri Experimental

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

Placebo Placebo Comparator

Other: Placebo

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

Associated severe chronic disease
Acute infectious disease
Personal or family first degree history of allergy to milk proteins
Several infants of the same family from a multiple pregnancy
Infants who received antibiotics one week prior to randomization
Infants who received probiotics one week prior to randomization
Mother who received antibiotics 1 week before randomization
Regular consumption of probiotics by the mother 1 week before randomization
Infants-included in another clinical study
Lack of insurance coverage by the french social security
Non exclusively breastfed infants
No Results Posted