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| Name | Class |
|---|---|
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
| FrieslandCampina, Amersfoort, The Netherlands | UNKNOWN |
| Sensus (Royal Cosun), the Netherlands. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oligosaccharide group 1 | Experimental |
| |
| oligosaccharide group 2 | Experimental |
| |
| placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dietary intervention with oligosaccharides | Other | intervention with oligosaccharide 1 or 2, or placebo, given once a day |
|
| 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. |
| 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 (%) |
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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:
Exclusion Criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clara Belzer, PhD | Contact | 0031317-483742 | clara.belzer@wur.nl | |
| Carrie A Wegh, MSc | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clara Belzer, PhD | Wageningen University and Research | Principal Investigator |
| Marc A Benninga, PhD | Emma Children's Hospital, UMC Amsterdam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emma Children's Hospital, UMC Amsterdam | Recruiting | Amsterdam | North Holland | 1105AZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38576033 | Derived | Wegh CAM, Schoterman MHC, Vaughan EE, van der Zalm SCC, Smidt H, Belzer C, A Benninga M. Effect of prebiotic oligosaccharides on bowel habit and the gut microbiota in children with functional constipation (Inside study): study protocol for a randomised, placebo-controlled, multi-centre trial. Trials. 2024 Apr 5;25(1):238. doi: 10.1186/s13063-024-08050-8. |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D009844 | Oligosaccharides |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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Parallel study with three arms of 13 weeks in total per participant.
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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. |