Last updated on July 2020

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Constipation
  • Age: Between 1 - 4 Years
  • Gender: Male or Female

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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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