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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 4, 2015
First Posted Date  ICMJE September 14, 2015
Last Update Posted Date September 14, 2015
Study Start Date  ICMJE March 2011
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2015)		 Stool frequency determined by daily questionnaire [ Time Frame: 4 weeks ]
Stool frequency determined by daily questionnaire.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2015)
  • 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.
  • 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).
  • 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).
  • Faecal microbiota composition determined by illumina sequencing [ Time Frame: 4 weeks ]
    Determined by illumina sequencing.
  • Stool metabolite profiling determined by GC/LC-MS [ Time Frame: 4 weeks ]
    Determined by GC/LC-MS.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Consumption of Orafti® Inulin on Bowel Motor Function in Subjects With Constipation
Official Title  ICMJE Effect of Consumption of Inulin on Bowel Motor Function in Subjects With Constipation
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Healthy
  • Constipation
Intervention  ICMJE
  • Dietary Supplement: Orafti® Inulin
    Dietary fiber
  • Dietary Supplement: Placebo
    Maltodextrin
Study Arms  ICMJE
  • Experimental: Orafti® Inulin
    Daily consumption of 12g Orafti® Inulin (3x 4g/d) over a period of 4 weeks
    Intervention: Dietary Supplement: Orafti® Inulin
  • Placebo Comparator: Placebo
    Daily consumption of 12g/ Maltodextrin (3x 4g/d) over a period of 4 weeks
    Intervention: Dietary Supplement: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2015)		 54
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02548247
Other Study ID Numbers  ICMJE BTS528_10
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Beneo GmbH
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Beneo GmbH
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel Menzel, MD BioTeSys GmbH
PRS Account Beneo GmbH
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP