The Inside Study: Oligosaccharides Versus Placebo in Functional Constipation

Not Applicable

• Conditions: Functional Constipation
• Interventions: Other: dietary intervention with oligosaccharides

• Registration Number: NCT04282551
• Lead Sponsor: Wageningen University and Research

Brief 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.

Study Timeline

• Study First Submitted: 2019-12-06
• Study First Submitted QC: 2020-02-21
• Study First Posted: 2020-02-24
• Study Start: 2020-06-24
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-11
• Last Update Posted: 2021-10-12
• Primary Completion: 2022-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

Not provided

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

• Children who suffer from any other GI complaints than functional constipation, known structural GI abnormalities, or previous GI surgery
• Any condition that would make it unsafe for the child to participate.
• Children with clinically significant cardiac, vascular, liver, pulmonary, psychiatric disorders, severe renal insufficiency, human immunodeficiency virus, acquired immunodeficiency syndrome, hepatitis B or C or known abnormalities of haematology, urinalysis, or blood biochemistry
• Children who are allergic to cow's milk or fish
• Use of antibiotics or other medicines or food supplements, and breast milk-feeding, 4 weeks prior to the study, except for the allowed escape medication
• Children that participate in another clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo group	dietary intervention with oligosaccharides	-
oligosaccharide group 1	dietary intervention with oligosaccharides	-
oligosaccharide group 2	dietary intervention with oligosaccharides	-

Primary Outcome Measures

Name	Time	Method
Stool consistency	Stool consistency will be measured at different time points during a study period of 13 weeks.	Change in stool consistency measured by the a stool questionnaire; 5 points stool scale from 1 hard to 5 watery (modified Bristol Stool Form Scale)

Secondary Outcome Measures

Name	Time	Method
Stool consistency in number of cases (%)	These outcome measures will be measured at different time point during a study period of 13 weeks.	Stool consistency - % of stools in a certain stool scale score as measured via a 5 point stool scale
Stool frequency in number of cases (%)	These outcome measures will be measured at different time point during a study period of 13 weeks.	Stool frequency - number of times a child has stools a day as reported in a diary.

Trial Locations

Locations (1)

Emma Children's Hospital, UMC Amsterdam; 🇳🇱 Amsterdam, Noord-Holland, Netherlands