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Infantile Colic | Lactobacillus Reuteri Supplementation in the Treatment of Infantile Colic

Infantile Colic research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Infantile Colic

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Dietary Supplement:Lactobacillus reuteri DSM17938 probioticDrops 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:PlaceboDrops suitable for infants. 2 X 5 drops / day will be issued, corresponding to the lipid emulsion without probiotics.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

PlaceboOther: Placebo

Study Status

Withdrawn

Start Date: October 2013

Completed Date: September 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: 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.

Secondary Outcome: The responders rates at D14 and D21 in the probiotic group compared to the placebo group.

Study sponsors, principal investigator, and references

Principal Investigator: Marc Bellaiche, MD

Lead Sponsor: BioGaia AB

Collaborator: CRC CHI Creteil France

More information:https://clinicaltrials.gov/show/NCT01887444

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