The Inside Study II: Oligosaccharides Versus Placebo and Hard Stools

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

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-28

Study Completion Date

2023-09-30

Brief Summary

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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.

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Detailed Description

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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

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Healthy With Hard and/or Lumpy Stools

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel study with two 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

intervention with oligosaccharides, total duration of study is 13 weeks

Group Type EXPERIMENTAL

oligosaccharides

Intervention Type OTHER

1 dose a day of oligosaccharides or placebo

placebo group

Placebo comparator, total duration of study is 13 weeks

Group Type PLACEBO_COMPARATOR

oligosaccharides

Intervention Type OTHER

1 dose a day of oligosaccharides or placebo

Interventions

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oligosaccharides

1 dose a day of oligosaccharides or placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Written informed consent
* aged 1-4 years
* Hard and/or firm stools as scored by a stool questionnaire

Exclusion Criteria

* Children that meet the Rome IV criteria for functional constipation
* Children who suffer from any other GI complaints, 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, as checked by the inclusion questionnaire.
* Children who are allergic to cow's milk or fish
* Use of antibiotics or other medicines or food supplements, and breast milkfeeding, which can influence defecation and gut microbiota 4 weeks prior to the study
* Children that participate in another clinical trial

Minimum Eligible Age

1 Year

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes