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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02548247
• Other study ID #: BTS528_10
• Status: Completed
• Phase: N/A
• First received: September 4, 2015
• Last updated: September 11, 2015
• Start date: March 2011
• Est. completion date: May 2012

Study information

• Verified date: September 2015
• Source: Beneo GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Healthy

Intervention

Dietary Supplement:
• Orafti® Inulin
Dietary fiber
• Placebo
Maltodextrin

Locations

Country	Name	City	State
Germany	BioTeSys GmbH	Esslingen

Sponsors (1)

Lead Sponsor	Collaborator
Beneo GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool frequency determined by daily questionnaire	Stool frequency determined by daily questionnaire.	4 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Faecal microbiota composition determined by illumina sequencing	Determined by illumina sequencing.	4 weeks	No
Secondary	Stool metabolite profiling determined by GC/LC-MS	Determined by GC/LC-MS.	4 weeks	No