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Investigation of the effects of a four week daily consumption of Orafti® Inulin on bowel motor function in subjects with constipation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orafti® Inulin | Experimental | Daily consumption of 12g Orafti® Inulin (3x 4g/d) over a period of 4 weeks |
|
| Placebo | Placebo Comparator | Daily consumption of 12g/ Maltodextrin (3x 4g/d) over a period of 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orafti® Inulin | Dietary Supplement | Dietary fiber |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Stool frequency determined by daily questionnaire | Stool frequency determined by daily questionnaire. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Stool consistency rated according to the Bristol Stool Form Scale | Stool consistency rated according to the Bristol Stool Form Scale from Type 1 to Type 7. | 4 weeks |
| Questionnaire on Gastrointestinal characteristics |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Menzel, MD | BioTeSys GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioTeSys GmbH | Esslingen am Neckar | 73728 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28213610 | Derived | Vandeputte D, Falony G, Vieira-Silva S, Wang J, Sailer M, Theis S, Verbeke K, Raes J. Prebiotic inulin-type fructans induce specific changes in the human gut microbiota. Gut. 2017 Nov;66(11):1968-1974. doi: 10.1136/gutjnl-2016-313271. Epub 2017 Feb 17. | |
| 27492975 | Derived | Micka A, Siepelmeyer A, Holz A, Theis S, Schon C. Effect of consumption of chicory inulin on bowel function in healthy subjects with constipation: a randomized, double-blind, placebo-controlled trial. Int J Food Sci Nutr. 2017 Feb;68(1):82-89. doi: 10.1080/09637486.2016.1212819. Epub 2016 Aug 5. |
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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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| Dietary Supplement |
Maltodextrin |
|
Sensation of straining, abdominal discomfort, bloating/distension, passage of gas and feeling of incomplete emptying rated on a 5-point scale (0 = not at all, 1 = very slightly, 2 = slightly, 3 = moderately, 4 = extremely).
| 4 weeks |
| Questionnaire on Participant Assessment of Constipation Quality of Life (PAC-QoL) | Severity of each symptom rated on a five-point scale from 0 (not at all / none of the time) to 4 (extremely / all of the time). | 4 weeks |
| Faecal microbiota composition determined by illumina sequencing | Determined by illumina sequencing. | 4 weeks |
| Stool metabolite profiling determined by GC/LC-MS | Determined by GC/LC-MS. | 4 weeks |