Effect of Consumption of Orafti® Inulin on Bowel Motor Function in Subjects With Constipation
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|ClinicalTrials.gov Identifier: NCT02548247|
Recruitment Status : Completed
First Posted : September 14, 2015
Last Update Posted : September 14, 2015
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|Condition or disease||Intervention/treatment||Phase|
|Healthy Constipation||Dietary Supplement: Orafti® Inulin Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Consumption of Inulin on Bowel Motor Function in Subjects With Constipation|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
Experimental: Orafti® Inulin
Daily consumption of 12g Orafti® Inulin (3x 4g/d) over a period of 4 weeks
Dietary Supplement: Orafti® Inulin
Placebo Comparator: Placebo
Daily consumption of 12g/ Maltodextrin (3x 4g/d) over a period of 4 weeks
Dietary Supplement: Placebo
- Stool frequency determined by daily questionnaire [ Time Frame: 4 weeks ]Stool frequency determined by daily questionnaire.
- Stool consistency rated according to the Bristol Stool Form Scale [ Time Frame: 4 weeks ]Stool consistency rated according to the Bristol Stool Form Scale from Type 1 to Type 7.
- Questionnaire on Gastrointestinal characteristics [ Time Frame: 4 weeks ]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).
- Questionnaire on Participant Assessment of Constipation Quality of Life (PAC-QoL) [ Time Frame: 4 weeks ]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).
- Faecal microbiota composition determined by illumina sequencing [ Time Frame: 4 weeks ]Determined by illumina sequencing.
- Stool metabolite profiling determined by GC/LC-MS [ Time Frame: 4 weeks ]Determined by GC/LC-MS.
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|Ages Eligible for Study:||20 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Healthy volunteers without clinical diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility.
- Constipation defined as an average of 2-3 stools per week. Volunteers should have had constipation for at least the previous 6 months.
- Age ≥ 20 and ≤ 75
- Subject under prescription for medication for digestive symptoms such as antispasmodic, laxatives, anti-diarrheic drugs or other digestive auxiliaries.
- Relevant history, presence of any medical disorder or chronic intake of medication/dietary supplements potentially interfering with this trial.
- Subjects with stool frequency of <1 stool every 7 days or more than 3 stools per week.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02548247
|Esslingen, Germany, 73728|
|Principal Investigator:||Daniel Menzel, MD||BioTeSys GmbH|
|Responsible Party:||Beneo GmbH|
|Other Study ID Numbers:||
|First Posted:||September 14, 2015 Key Record Dates|
|Last Update Posted:||September 14, 2015|
|Last Verified:||September 2015|
Bowel motor function
Signs and Symptoms, Digestive