NCT04295213

The Inside Study II: Oligosaccharides Versus Placebo and Hard Stools

The Effect of a Oligosaccharides Versus a Placebo on Defecation Parameters in Healthy Children With Hard or Lumpy Stools

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 196 (estimated)
• Sponsor: Wageningen University and Research · Academic / Other
• Sex: All
• Age: 1 Year – 3 Years
• Healthy volunteers: Accepted

Summary

In the present randomised double blind controlled study, we will study the effects of a oligosaccharides vs a placebo on the change in stool consistency and stool frequency in children with hard or lumpy stools.

Detailed description

Firm, hard or lumpy stools can be problematic for young children and might come as a precursor of functional constipation in childhood. The cause of harder stools in childhood is incompletely understood. But it is likely that harder stools in childhood are linked to among others withholding behaviour of stools and a low fibre intake. As hard stools may precede functional constipation, the aim of the study is to investigate the effect of a prebiotic fiber versus a placebo on defecation parameters in healthy children with hard or lumpy stools. We hypothesize that consumption of a prebiotic fiber results in softer stools.

Conditions

• Healthy With Hard and/or Lumpy Stools

Interventions

Type	Name	Description
OTHER	oligosaccharides	1 dose a day of oligosaccharides or placebo

Timeline

• Start date: 2021-04-28
• Primary completion: 2023-07-01
• Completion: 2023-09-01
• First posted: 2020-03-04
• Last updated: 2022-07-13

Locations

1 site across 1 country: Netherlands