Lactobacillus Reuteri Supplementation in the Treatment of Infantile Colic (PROBIOC)

BioGaia

Status: Withdrawn

Conditions: Infantile Colic

Treatments: Dietary Supplement: Lactobacillus reuteri DSM17938 probiotic; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01887444

2013-A00163-42

Details and patient eligibility

About

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.

Full description

NOTE: The study never started.

Sex: All

Ages: 29 days to 3 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Lactobacillus reteuri

Experimental group

Description:

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

Treatment:

Dietary Supplement: Lactobacillus reuteri DSM17938 probiotic

Placebo

Placebo Comparator group

Description:

Other: Placebo

Treatment:

Other: Placebo