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

• Status: Completed
• Trial end date: 2021-07-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Intercommunal Creteil
• Collaborator: BioGaia AB

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