Lactobacillus Reuteri Supplementation in the Treatment of Infantile Colic

Infantile Colic Clinical Trial

— PROBIOC  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01887444
• Other study ID #: 2013-A00163-42
• Status: Withdrawn
• Phase: N/A
• Start date: October 2013
• Est. completion date: September 2014

Study information

• Verified date: September 2015
• Source: BioGaia AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

NOTE: The study never started.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Months

Eligibility

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

Related Conditions & MeSH terms

• Colic
• Infantile Colic

Intervention

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.

Locations

Country	Name	City	State
France	CRC CHIC and ACTIV	Créteil

Sponsors (4)

Lead Sponsor	Collaborator
BioGaia AB	Association Clinique Thérapeutique Infantile du val de Marne, CRC CHI Creteil France, Robert Debré Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The average duration of crying in the probiotic group compared with the placebo group at D7, D14 and D21.		Day 7, 14 and 21
Other	Gastrointestinal symptoms (constipation, diarrhea, flatulence) evaluated at each visit required by the protocol		day 7, 14 and 21
Primary	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.		day 7
Secondary	The responders rates at D14 and D21 in the probiotic group compared to the placebo group.		Day 14 and day 21