The Inside Study: Oligosaccharides Versus Placebo in Functional Constipation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-24

Study Completion Date

2022-11-30

Brief Summary

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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.

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Detailed Description

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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

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Functional Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel study with three arms of 13 weeks in total per participant.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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oligosaccharide group 1

Group Type EXPERIMENTAL

dietary intervention with oligosaccharides

Intervention Type OTHER

intervention with oligosaccharide 1 or 2, or placebo, given once a day

oligosaccharide group 2

Group Type EXPERIMENTAL

dietary intervention with oligosaccharides

Intervention Type OTHER

intervention with oligosaccharide 1 or 2, or placebo, given once a day

placebo group

Group Type PLACEBO_COMPARATOR

dietary intervention with oligosaccharides

Intervention Type OTHER

intervention with oligosaccharide 1 or 2, or placebo, given once a day

Interventions

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dietary intervention with oligosaccharides

intervention with oligosaccharide 1 or 2, or placebo, given once a day

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Written informed consent
* Aged 1-3 years
* Children that meet the Rome IV criteria for functional constipation

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

Minimum Eligible Age

1 Year

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No