The Inside Study: Oligosaccharides Versus Placebo in Functional Constipation
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Functional Constipation
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Parallel study with three arms of 13 weeks in total per participant.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 1 years and 3 years
- Gender
- Both males and females
Description
Functional constipation (FC) in children is a common gastrointestinal (GI) disorder with a worldwide prevalence ranging from 0.7% to 29.6%. Complaints include infrequent bowel movement, painful defecation due to hard and/or large stools, fecal incontinence, and abdominal pain. Although the condition...
Functional constipation (FC) in children is a common gastrointestinal (GI) disorder with a worldwide prevalence ranging from 0.7% to 29.6%. Complaints include infrequent bowel movement, painful defecation due to hard and/or large stools, fecal incontinence, and abdominal pain. Although the condition is rarely life-threatening, it strongly impairs quality of life. Oligosaccharides have been shown to relieve constipation symptoms in young adults and elderly. However, sufficient evidence is lacking linking oligosaccharides intake to improve symptoms in children with FC. The investigators hypothesize that oligosaccharides might be able to relieve symptoms of constipation in young children as well, among which softening stools.
Tracking Information
- NCT #
- NCT04282551
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- FrieslandCampina, Amersfoort, The Netherlands
- Sensus (Royal Cosun), the Netherlands.
- Investigators
- Principal Investigator: Clara Belzer, PhD Wageningen University and Research Principal Investigator: Marc A Benninga, PhD Emma Children's Hospital, UMC Amsterdam
Get Well Soon