The Inside Study II: Oligosaccharides Versus Placebo and Hard Stools

Not Applicable

• Conditions: Healthy With Hard and/or Lumpy Stools
• Interventions: Other: oligosaccharides

• Registration Number: NCT04295213
• Lead Sponsor: Wageningen University and Research

Brief 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.

Study Timeline

• Study First Submitted: 2020-03-02
• Study First Submitted QC: 2020-03-02
• Study First Posted: 2020-03-04
• Study Start: 2021-04-28
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-12
• Last Update Posted: 2022-07-13
• Primary Completion: 2023-07
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 196

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oligosaccharide group	oligosaccharides	intervention with oligosaccharides, total duration of study is 13 weeks
placebo group	oligosaccharides	Placebo comparator, total duration of study is 13 weeks

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 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.by a stool questionnaire
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

Trial Locations

Locations (1)

Wageningen University and Research; 🇳🇱 Wageningen, Gelderland, Netherlands