Effect of L. Reuteri on Bowel Movements in Children (BIOWELL Study)

NCT ID: NCT03030664

Last Updated: 2022-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2021-07-30

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.

Detailed Description

Functional constipation in infants up to 4 years of age is defined according to Rome III criteria (Hyman 2006). The diagnose must include 1 month of at least two of the following criteria: two or fewer defecations per week; at least 1 episode per week of incontinence after the acquisition of toilet skills; history of excessive stool retention; history of painful or hard bowel movements; presence of a large faecal mass in the rectum; history of large-diameter stools that may obstruct the toilet.

Accompanying symptoms may include irritability, decreased appetite and/or early satiety. The accompanying symptoms disappear immediately following passage of a large stool.

There is a growing interest for the use of probiotics in functional constipation as research suggests that probiotics could provide beneficial support in the traditional treatment arsenal although the mechanisms of actions are not completely understood.

Wu et al have demonstrated that Lactobacillus reuteri DSM 17938 may have a region-specific intestinal effect on gut motility and therefore could be beneficial in treatment of constipation

Lactobacillus reuteri DSM 17938 has shown significant favourable effects in adults (Ojetti 2014) and young children as described above (Coccorullo 2010, Olgac 2013). These studies require confirmation however. The present clinical study has been designed to strengthen the current available data that L. reuteri DSM 17938 has beneficial effects in infants and young children with functional constipation.

We hypothesize that daily oral supplementation with the probiotic Lactobacillus reuteri DSM 17938 will effectively increase the number of spontaneous bowel movements in infants/children diagnosed with functional constipation according to Rome IV.

Conditions

Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

L.reuteri

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

Group Type: ACTIVE_COMPARATOR

L.reuteri

Intervention Type: DIETARY_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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Same formulation as study product, without probiotics.

Interventions

L.reuteri

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Same formulation as study product, without probiotics.

Intervention Type: DRUG

Other Intervention Names

Lactobacillus reuteri

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioGaia AB

INDUSTRY

Sponsor Role: collaborator

Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role: lead

Responsible Party

Camille JUNG

Head of the clinical research department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marc BELLAICHE, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Universitaire Robert-Debre

Locations

CH Sud francilien

Corbeil-Essonnes, , France

CHI Creteil

Créteil, , France

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

Le Havre, , France

Hôpital Saint Vincent-de-Paul

Lille, , France

CHU Robert Debré

Paris, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 36389355 (View on PubMed)

Other Identifiers

2016-A00419-42

Identifier Type: OTHER

Identifier Source: secondary_id

BIOWELL

Identifier Type: -

Identifier Source: org_study_id