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

Primary Purpose

Healthy, Constipation

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Orafti® Inulin
Placebo
Sponsored by
Beneo GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy focused on measuring Stool frequency, Bowel motor function, Orafti® Inulin, Dietary Fiber

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • BioTeSys GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Orafti® Inulin

Placebo

Arm Description

Daily consumption of 12g Orafti® Inulin (3x 4g/d) over a period of 4 weeks

Daily consumption of 12g/ Maltodextrin (3x 4g/d) over a period of 4 weeks

Outcomes

Primary Outcome Measures

Stool frequency determined by daily questionnaire
Stool frequency determined by daily questionnaire.

Secondary Outcome Measures

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.
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).
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).
Faecal microbiota composition determined by illumina sequencing
Determined by illumina sequencing.
Stool metabolite profiling determined by GC/LC-MS
Determined by GC/LC-MS.

Full Information

First Posted
September 4, 2015
Last Updated
September 11, 2015
Sponsor
Beneo GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02548247
Brief Title
Effect of Consumption of Orafti® Inulin on Bowel Motor Function in Subjects With Constipation
Official Title
Effect of Consumption of Inulin on Bowel Motor Function in Subjects With Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beneo GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Constipation
Keywords
Stool frequency, Bowel motor function, Orafti® Inulin, Dietary Fiber

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Orafti® Inulin
Arm Type
Experimental
Arm Description
Daily consumption of 12g Orafti® Inulin (3x 4g/d) over a period of 4 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Daily consumption of 12g/ Maltodextrin (3x 4g/d) over a period of 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Orafti® Inulin
Intervention Description
Dietary fiber
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Maltodextrin
Primary Outcome Measure Information:
Title
Stool frequency determined by daily questionnaire
Description
Stool frequency determined by daily questionnaire.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Stool consistency rated according to the Bristol Stool Form Scale
Description
Stool consistency rated according to the Bristol Stool Form Scale from Type 1 to Type 7.
Time Frame
4 weeks
Title
Questionnaire on Gastrointestinal characteristics
Description
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).
Time Frame
4 weeks
Title
Questionnaire on Participant Assessment of Constipation Quality of Life (PAC-QoL)
Description
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).
Time Frame
4 weeks
Title
Faecal microbiota composition determined by illumina sequencing
Description
Determined by illumina sequencing.
Time Frame
4 weeks
Title
Stool metabolite profiling determined by GC/LC-MS
Description
Determined by GC/LC-MS.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Menzel, MD
Organizational Affiliation
BioTeSys GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
BioTeSys GmbH
City
Esslingen
ZIP/Postal Code
73728
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
28213610
Citation
Vandeputte D, Falony G, Vieira-Silva S, Wang J, Sailer M, Theis S, Verbeke K, Raes J. Prebiotic inulin-type fructans induce specific changes in the human gut microbiota. Gut. 2017 Nov;66(11):1968-1974. doi: 10.1136/gutjnl-2016-313271. Epub 2017 Feb 17.
Results Reference
derived
PubMed Identifier
27492975
Citation
Micka A, Siepelmeyer A, Holz A, Theis S, Schon C. Effect of consumption of chicory inulin on bowel function in healthy subjects with constipation: a randomized, double-blind, placebo-controlled trial. Int J Food Sci Nutr. 2017 Feb;68(1):82-89. doi: 10.1080/09637486.2016.1212819. Epub 2016 Aug 5.
Results Reference
derived

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

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