NCT04282551

The Inside Study: Oligosaccharides Versus Placebo in Functional Constipation

The Effect of Oligosaccharides Versus a Placebo on Bowel Habits in Children With Functional Constipation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: Wageningen University and Research · Academic / Other
• Sex: All
• Age: 1 Year – 3 Years
• Healthy volunteers: Not accepted

Summary

In the present randomised double blind controlled study, the investigators will study the effects of oligosaccharides vs a placebo on the change in stool consistency and stool frequency in children with functional constipation.

Detailed 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 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.

Conditions

• Functional Constipation

Interventions

Type	Name	Description
OTHER	dietary intervention with oligosaccharides	intervention with oligosaccharide 1 or 2, or placebo, given once a day

Timeline

• Start date: 2020-06-24
• Primary completion: 2022-11-01
• Completion: 2022-11-01
• First posted: 2020-02-24
• Last updated: 2021-10-12

Locations

1 site across 1 country: Netherlands