The Inside Study II: Oligosaccharides Versus Placebo and Hard Stools

Study Overview
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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.

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.

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

Conditions
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Healthy With Hard and/or Lumpy Stools

Intervention / Treatment
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* Other: oligosaccharides


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel study with two arms of 13 weeks in total per participant
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oligosaccharide group<br>intervention with oligosaccharides, total duration of study is 13 weeks | Other: oligosaccharides<br>* 1 dose a day of oligosaccharides or placebo<br>|
| Placebo Comparator: placebo group<br>Placebo comparator, total duration of study is 13 weeks | Other: oligosaccharides<br>* 1 dose a day of oligosaccharides or placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool consistency | 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) | Stool consistency will be measured at different time points during a study period of 13 weeks. | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oligosaccharides