The Inside Study: Oligosaccharides Versus Placebo in Functional Constipation
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: oligosaccharide group 1
|
Other: dietary intervention with oligosaccharides
intervention with oligosaccharide 1 or 2, or placebo, given once a day
|
| Experimental: oligosaccharide group 2
|
Other: dietary intervention with oligosaccharides
intervention with oligosaccharide 1 or 2, or placebo, given once a day
|
| Placebo Comparator: placebo group
|
Other: dietary intervention with oligosaccharides
intervention with oligosaccharide 1 or 2, or placebo, given once a day
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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
Eligibility Criteria
Criteria
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.
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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
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Children who are allergic to cow's milk or fish
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Emma Children's Hospital, UMC Amsterdam | Amsterdam | Noord-Holland | Netherlands | 1105AZ |
Sponsors and Collaborators
- Wageningen University and Research
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- FrieslandCampina, Amersfoort, The Netherlands
- Sensus (Royal Cosun), the Netherlands.
Investigators
- Principal Investigator: Clara Belzer, PhD, Wageningen University and Research
- Principal Investigator: Marc A Benninga, PhD, Emma Children's Hospital, UMC Amsterdam
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NL70126.081.19