Effect of Consumption of Orafti® Inulin on Bowel Motor Function in Subjects With Constipation

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Consumption of Inulin on Bowel Motor Function in Subjects With Constipation

Conditions
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Healthy, Constipation

Intervention / Treatment
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* Dietary Supplement: Orafti® Inulin
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orafti® Inulin<br>Daily consumption of 12g Orafti® Inulin (3x 4g/d) over a period of 4 weeks | Dietary Supplement: Orafti® Inulin<br>* Dietary fiber<br>|
| Placebo Comparator: Placebo<br>Daily consumption of 12g/ Maltodextrin (3x 4g/d) over a period of 4 weeks | Dietary Supplement: Placebo<br>* Maltodextrin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool frequency determined by daily questionnaire | Stool frequency determined by daily questionnaire. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stool frequency, Bowel motor function, Orafti® Inulin, Dietary Fiber