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Gastrointestinal discomfort regularly affects >25% of the population worldwide. One of the major contributors to GI discomfort is constipation, which has a prevalence of ~15% and symptoms of which have a significant negative impact on the sufferer's quality of life. One of the hallmarks of chronic constipation is slow progression of contents through the gut (i.e. slow gut / colonic transit time), which may be associated with hard stools that are difficult to expel.
Dietary fiber supplements are widely used as a first-line treatment for constipation although little Level 1 evidence exists to support its use in adults. The effectiveness of different fiber supplements is difficult to compare given wide differences in water-retention capabilities and effects on the colonic microbial ecology. Given the promising, yet largely unsubstantiated, benefits of fiber supplementation on symptoms of functional constipation, the objective of this clinical trial is to evaluate tolerance and effectiveness of four week supplementation of a fiber product, in a dose-ranging fashion, on whole gut transit time and gastrointestinal symptoms in adults with functional constipation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High quantity fiber food product | Experimental |
| |
| Low quantity fiber food product | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High quantity fiber | Other | The intervention type is food product |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Whole gut transit time | To evaluate change in whole gut transit time 2 weeks after consumption of the study product in constipated patients consuming the study product containing fiber in high quantity, compared to those consuming placebo | After 2 weeks consumption of the study product |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal symptoms | To evaluate change in Gastrointestinal symptoms 2&4 weeks after consumption of the study product in all groups | After 2&4 weeks consumption of the study product |
| Regional colonic transit time |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Adverse events assessed as treatment emergent adverse events (TEAEs) | Through the study product consumption period (4 weeks) |
| Gut Health Insight Survey | To gain insights into patient-specific constipation symptomology |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diederick E. Grobbee, Prof, MD, PhD | Julius Clinical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Julius Clinical | Zeist | 3703 CD | Netherlands |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Low quantity fiber |
| Other |
The intervention type is food product |
|
| Placebo | Other |
|
To evaluate change in the regional (right colon, left colon, and rectosigmoid tranist time 2 weeks after consumption of the study product in all groups
| After 2 weeks consumption of the study product |
| Whole gut transit time | To evaluate change in whole gut transit time 2 weeks after consumption of the study product in constipated patients consuming the study product containing fiber in low quantity, compared to those consuming placebo | After 2 weeks consumption of the study product |
| Tolerance | To assess tolerance to the study product 1&2&4 weeks after consumption in all groups, using a questionnaire | After 1&2&4 weeks consumption of the study product |
| At screening, after informed consent |