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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01887444

Acronym

PROBIOC

Enrollment

Registered

2013-06-26

Start date

2013-10-31

Completion date

2014-09-30

Last updated

2021-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infantile Colic

Keywords

Pediatric Gastroenterology, Probiotics, Lactobacillus reuteri

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.

Interventions

DIETARY_SUPPLEMENTLactobacillus 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.

OTHERPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

29 Days to 3 Months

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
The responders rates at D14 and D21 in the probiotic group compared to the placebo group.	Day 14 and day 21

Other

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026