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

September 11, 2015 updated by: Beneo GmbH

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

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

Study Overview

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Esslingen, Germany, 73728
        • BioTeSys GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stool frequency determined by daily questionnaire
Time Frame: 4 weeks
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
Time Frame: 4 weeks
Stool consistency rated according to the Bristol Stool Form Scale from Type 1 to Type 7.
4 weeks
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).
4 weeks
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).
4 weeks
Faecal microbiota composition determined by illumina sequencing
Time Frame: 4 weeks
Determined by illumina sequencing.
4 weeks
Stool metabolite profiling determined by GC/LC-MS
Time Frame: 4 weeks
Determined by GC/LC-MS.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

September 4, 2015

First Submitted That Met QC Criteria

September 11, 2015

First Posted (Estimate)

September 14, 2015

Study Record Updates

Last Update Posted (Estimate)

September 14, 2015

Last Update Submitted That Met QC Criteria

September 11, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTS528_10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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