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

Constipation Clinical Trial

— BIOWELL  

Official title:

Randomised Controlled Trial With Two Parallel Arms Testing the Effect of L. Reuteri on Bowel Movements in Children Aged 6 Months to 4 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03030664
• Other study ID #: BIOWELL
• Secondary ID: 2016-A00419-42
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: July 30, 2021

Study information

• Verified date: June 2022
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 4 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation

Intervention

Dietary Supplement:
• 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

Drug:
• Placebo
Same formulation as study product, without probiotics.

Locations

Country	Name	City	State
France	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

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil	BioGaia AB

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	rescue medication	Total number of rescue medication during the intervention period	week 4
Secondary	fecal retention	number of subjects with 3 or more than 3 stools per week and without fecal retention at the last week of the intervention period	week 4
Secondary	weekly number of spontaneous bowel movements	weekly number of spontaneous bowel movements evaluated by the Bowel habit Questionnaire	week 1
Secondary	weekly number of spontaneous bowel movements	weekly number of spontaneous bowel movements evaluated by the Bowel habit Questionnaire	week 2
Secondary	weekly number of spontaneous bowel movements	weekly number of spontaneous bowel movements evaluated by the Bowel habit Questionnaire	week 3
Secondary	weekly number of spontaneous bowel movements	weekly number of spontaneous bowel movements evaluated by the Bowel habit Questionnaire	week 4
Secondary	weekly number of spontaneous bowel movements	weekly number of spontaneous bowel movements evaluated by the Bowel habit Questionnaire	week 8
Secondary	Score of QOL	Score of quality of life measured using the PedsQL Parent family acute version	baseline
Secondary	Score of QOL	Score of quality of life measured using the PedsQL Parent family acute version	week 4
Secondary	Score of QOL	Score of quality of life measured using the PedsQL Parent family acute version	week 8
Secondary	Pain during defecation	Score of pain during defecation measured using Hick or Wong baker faces	baseline
Secondary	Pain during defecation	Score of pain during defecation measured using Hick or Wong baker faces	week 4
Secondary	Pain during defecation	Score of pain during defecation measured using Hick or Wong baker faces	week 8