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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
Sponsor:
Information provided by (Responsible Party):
Beneo GmbH

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

Condition or disease Intervention/treatment Phase
Healthy Constipation Dietary Supplement: Orafti® Inulin Dietary Supplement: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
Drug Information available for: Inulin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Orafti® Inulin
Daily consumption of 12g Orafti® Inulin (3x 4g/d) over a period of 4 weeks
 Dietary Supplement: Orafti® Inulin
Dietary fiber
Placebo Comparator: Placebo
Daily consumption of 12g/ Maltodextrin (3x 4g/d) over a period of 4 weeks
 Dietary Supplement: Placebo
Maltodextrin


Outcome Measures
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Primary Outcome Measures :
  1. Stool frequency determined by daily questionnaire [ Time Frame: 4 weeks ]
    Stool frequency determined by daily questionnaire.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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. Faecal microbiota composition determined by illumina sequencing [ Time Frame: 4 weeks ]
    Determined by illumina sequencing.

  5. Stool metabolite profiling determined by GC/LC-MS [ Time Frame: 4 weeks ]
    Determined by GC/LC-MS.


Eligibility Criteria
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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
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Germany
BioTeSys GmbH
Esslingen, Germany, 73728
Sponsors and Collaborators
Beneo GmbH
Investigators
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Principal Investigator: Daniel Menzel, MD BioTeSys GmbH
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Beneo GmbH
ClinicalTrials.gov Identifier: NCT02548247    
Other Study ID Numbers: BTS528_10
First Posted: September 14, 2015    Key Record Dates
Last Update Posted: September 14, 2015
Last Verified: September 2015
Keywords provided by Beneo GmbH:
Stool frequency
Bowel motor function
Orafti® Inulin
Dietary Fiber
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive