NCT03030664

Brief Summary

A randomized, multicenter, placebo-controlled, double blind study in two parallel groups testing the efficacy of daily oral supplementation with the probiotic L.reuteri DSM17938 compared to placebo in increasing the number of spontaneous bowel movements in infants and children with functional constipation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

June 13, 2022

Status Verified

June 1, 2022

Enrollment Period

4.3 years

First QC Date

January 23, 2017

Last Update Submit

June 9, 2022

Conditions

Constipation

Keywords

constipationLactobacillus reuteriprobiotics

Outcome Measures

Primary Outcomes (1)

  • Change in number of spontaneous bowel movements

    Change in number of spontaneous bowel movements at week 4 compared to baseline evaluated by a bowel habit questionnaire (BQH)

    Week 4

Secondary Outcomes (13)

  • rescue medication

    week 4

  • fecal retention

    week 4

  • weekly number of spontaneous bowel movements

    week 1

  • weekly number of spontaneous bowel movements

    week 2

  • weekly number of spontaneous bowel movements

    week 3

  • +8 more secondary outcomes

Study Arms (2)

L.reuteri

ACTIVE COMPARATOR

probiotics: L.reuteri produced by Biogaia 5 drops per day: 10exp(8) colony forming unit will be delivered

Dietary Supplement: L.reuteri

Placebo

PLACEBO COMPARATOR

Same formulation as probiotics, without active substance. 5 drops per day will be delivered

Drug: Placebo

Interventions

L.reuteriDIETARY_SUPPLEMENT

Each day, at about the same time, the subjects will be given 5 drops (1x10\^8 CFU) of the study product in connection with feeding

Also known as: Lactobacillus reuteri
L.reuteri
PlaceboDRUG

Same formulation as study product, without probiotics.

Placebo

Eligibility Criteria

Age6 Months - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age: 6 months up to 4 years
  • Suffering from functional constipation, as defined by modified Rome III criteria for children aged 4 years or less (Hyman 2006)
  • Parent(s) willingness to postpone major changes in the infant feeding mode
  • Parent(s) willingness and ability to fill in diary and questionnaires
  • Written informed consent from parents
  • Stated availability throughout the study period

You may not qualify if:

  • Chronic illness or major medical problem
  • Gastrointestinal disease (including organic cause of constipation and dyschezia or history of severe fecalome)
  • Intractable constipation (not responding to conventional treatment for more than 3 months)
  • Gastrointestinal surgery (in the year before enrolment)
  • Food allergy, lactose or gluten intolerance, as declared by parents
  • Use of L. reuteri two weeks before randomisation and throughout the intervention period. If fed with infant formula, it cannot contain L. reuteri.
  • Use of antibiotics two weeks before randomisation and throughout the intervention period, both infant/child and lactating mother
  • If breastfeeding, use of L reuteri by the mother 2 weeks prior to enrolment
  • Conventional treatment for constipation within 2 weeks before enrolment
  • Medication that influences gastrointestinal motility
  • Mental or behavioral disorders as judged by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CH Sud francilien

Corbeil-Essonnes, France

Location

CHI Creteil

Créteil, 94000, France

Location

Hôpital J. Monod - Pavillon Femme Mère Enfant - Le Havre

Le Havre, France

Location

Hôpital Saint Vincent-de-Paul

Lille, France

Location

CHU Robert Debré

Paris, France

Location

Related Publications (1)

  • Jung C, Kalach N, Degas V, Jeridi Y, Bertrand V, Bellaiche M. Effect of L. reuteri on bowel movements in children aged 6 months to 4 years: A double-blind randomized controlled trial. Front Pediatr. 2022 Oct 26;10:997104. doi: 10.3389/fped.2022.997104. eCollection 2022.

    PMID: 36389355DERIVED

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marc BELLAICHE, MD

    Hopital Universitaire Robert-Debre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the clinical research department

Study Record Dates

First Submitted

January 23, 2017

First Posted

January 25, 2017

Study Start

March 1, 2017

Primary Completion

June 30, 2021

Study Completion

July 30, 2021

Last Updated

June 13, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(5)