NCT01887444

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 26, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

February 4, 2021

Status Verified

September 1, 2015

Enrollment Period

7 months

First QC Date

June 20, 2013

Last Update Submit

February 2, 2021

Conditions

Infantile Colic

Keywords

Pediatric GastroenterologyProbioticsLactobacillus reuteri

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The responders rates at D14 and D21 in the probiotic group compared to the placebo group.

    Day 14 and day 21

Other Outcomes (2)

  • 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

Study Arms (2)

Lactobacillus reteuri

EXPERIMENTAL

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

Dietary Supplement: Lactobacillus reuteri DSM17938 probiotic

Placebo

PLACEBO COMPARATOR

Other: Placebo

Other: Placebo

Interventions

Lactobacillus reuteri DSM17938 probioticDIETARY_SUPPLEMENT

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.

Lactobacillus reteuri
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age29 Days - 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRC CHIC and ACTIV

Créteil, 94010, France

Location

MeSH Terms

Conditions

Colic

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Marc Bellaiche, MD

    Hopital Universitaire Robert-Debre

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2013

First Posted

June 26, 2013

Study Start

October 1, 2013

Primary Completion

May 1, 2014

Study Completion

September 1, 2014

Last Updated

February 4, 2021

Record last verified: 2015-09

Locations

FR(1)