The Benefit of Using the Lactobacillus Reuteri Probiotic as a Supplement in the Treatment of Newborn Colic
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- BioGaia AB
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 29 Days to 3 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Lactobacillus reteuri
Dietary Supplement: Lactobacillus reuteri DSM17938 probiotic 2 x 10(8) CFU/day 21 days
Intervention: Lactobacillus reuteri DSM17938 probiotic (Dietary Supplement)
Placebo
Other: Placebo
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
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.
Time Frame: day 7
Secondary Outcomes
- The responders rates at D14 and D21 in the probiotic group compared to the placebo group.(Day 14 and day 21)