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

Not Applicable

Completed

• Conditions: Healthy; Constipation
• Interventions: Dietary Supplement: Orafti® Inulin; Dietary Supplement: Placebo

• Registration Number: NCT02548247
• Lead Sponsor: Beneo GmbH

Brief Summary

Investigation of the effects of a four week daily consumption of Orafti® Inulin on bowel motor function in subjects with constipation.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2015-09
• Study First Submitted: 2015-09-04
• Study First Submitted QC: 2015-09-11
• Last Update Submitted: 2015-09-11
• Study First Posted: 2015-09-14
• Last Update Posted: 2015-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Orafti® Inulin	Orafti® Inulin	Daily consumption of 12g Orafti® Inulin (3x 4g/d) over a period of 4 weeks
Placebo	Placebo	Daily consumption of 12g/ Maltodextrin (3x 4g/d) over a period of 4 weeks

Primary Outcome Measures

Name	Time	Method
Stool frequency determined by daily questionnaire	4 weeks	Stool frequency determined by daily questionnaire.

Secondary Outcome Measures

Name	Time	Method
Faecal microbiota composition determined by illumina sequencing	4 weeks	Determined by illumina sequencing.
Questionnaire on Participant Assessment of Constipation Quality of Life (PAC-QoL)	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).
Stool metabolite profiling determined by GC/LC-MS	4 weeks	Determined by GC/LC-MS.
Questionnaire on Gastrointestinal characteristics	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).
Stool consistency rated according to the Bristol Stool Form Scale	4 weeks	Stool consistency rated according to the Bristol Stool Form Scale from Type 1 to Type 7.

Trial Locations

Locations (1)

BioTeSys GmbH; 🇩🇪 Esslingen, Germany