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| Name | Class |
|---|---|
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
| FrieslandCampina, Amersfoort, The Netherlands | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oligosaccharide group | Experimental | intervention with oligosaccharides, total duration of study is 13 weeks |
|
| placebo group | Placebo Comparator | Placebo comparator, total duration of study is 13 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oligosaccharides | Other | 1 dose a day of oligosaccharides or placebo |
|
| 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.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 (%) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clara Belzer, PhD | Contact | 0031317-483 742 | clara.belzer@wur.nl | |
| Carrie Wegh, MSc | Contact | carrie.wegh@wur.nl |
| Name | Affiliation | Role |
|---|---|---|
| Clara Belzer, PhD | Wageningen University and Research | Principal Investigator |
| Marc Benninga, PhD | Emma Children's Hospital, UMC Amsterdam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wageningen University and Research | Recruiting | Wageningen | Gelderland | 6708 WE | Netherlands |
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| ID | Term |
|---|---|
| D009844 | Oligosaccharides |
| ID | Term |
|---|---|
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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Parallel study with two 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. |