The Inside Study: Oligosaccharides Versus Placebo in Functional Constipation

Study Overview
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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.

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.

Official Title
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The Effect of Oligosaccharides Versus a Placebo on Bowel Habits in Children With Functional Constipation

Conditions
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Functional Constipation

Intervention / Treatment
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* Other: dietary intervention with oligosaccharides


Participation Criteria
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Eligibility Criteria
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In order to be eligible to participate in this study, a subject must meet all of the following criteria, as considered by a medical doctor: 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

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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No

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 three arms of 13 weeks in total per participant.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oligosaccharide group 1<br> | Other: dietary intervention with oligosaccharides<br>* intervention with oligosaccharide 1 or 2, or placebo, given once a day<br>|
| Experimental: oligosaccharide group 2<br> | Other: dietary intervention with oligosaccharides<br>* intervention with oligosaccharide 1 or 2, or placebo, given once a day<br>|
| Placebo Comparator: placebo group<br> | Other: dietary intervention with oligosaccharides<br>* intervention with oligosaccharide 1 or 2, or placebo, given once a day<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. | 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