HealthyNCT02548247
Effect of Consumption of Orafti® Inulin on Bowel Motor Function in Subjects With Constipation
A study testing Orafti® Inulin in people with Healthy and Constipation, run by Beneo GmbH at 1 site in Germany.
Trial summary
Investigation of the effects of a four week daily consumption of Orafti® Inulin on bowel motor function in subjects with constipation. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Constipation
- What is being tested?
- Orafti® Inulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2011to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy, Constipation
- Being tested
- Orafti® Inulin, Placebo
- Keywords
- Stool frequency, Bowel motor function, Orafti® Inulin, Dietary Fiber
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orafti® InulinDietary supplement
Dietary fiber
PlaceboDietary supplement
Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Orafti® Inulin | Experimental | Daily consumption of 12g Orafti® Inulin (3x 4g/d) over a period of 4 weeks Receives: Dietary Supplement: Orafti® Inulin |
| Placebo | Placebo comparator | Daily consumption of 12g/ Maltodextrin (3x 4g/d) over a period of 4 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool frequency determined by daily questionnaire
Stool frequency determined by daily questionnaire.
Measured: 4 weeks
Secondary outcomes (5)
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.
Measured: 4 weeks
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).
Measured: 4 weeks
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).
Measured: 4 weeks
Faecal microbiota composition determined by illumina sequencing
Determined by illumina sequencing.
Measured: 4 weeks
Stool metabolite profiling determined by GC/LC-MS
Determined by GC/LC-MS.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study startMar 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beneo GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Menzel, MD, Principal investigator, BioTeSys GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548247
- Sponsor's protocol ID
- BTS528_10
- Status last verified
- Sep 2015
- First submitted
- 4 Sep 2015
- Last updated
- 14 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28213610Micka 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.
PubMed 27492975
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Consumption of Inulin on Bowel Motor Function in Subjects With Constipation
- ClinicalTrials.gov ID
- NCT02548247
- Acronym / sponsor ID
- BTS528_10
- Conditions
- Healthy, Constipation
- Keywords
- Stool frequency, Bowel motor function, Orafti® Inulin, Dietary Fiber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Beneo GmbHIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 14 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigation of the effects of a four week daily consumption of Orafti® Inulin on bowel motor function in subjects with constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orafti® Inulin | Experimental | Dietary Supplement: Orafti® InulinDaily consumption of 12g Orafti® Inulin (3x 4g/d) over a period of 4 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDaily consumption of 12g/ Maltodextrin (3x 4g/d) over a period of 4 weeks |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orafti® InulinDietary fiber | Dietary supplement | Orafti® Inulin |
| PlaceboMaltodextrin | Dietary supplement | Placebo |
Primary outcome
Stool frequency determined by daily questionnaire
Time frame: 4 weeks
Stool frequency determined by daily questionnaire.
5 secondary outcomes
Stool consistency rated according to the Bristol Stool Form Scale
Time frame: 4 weeks
Questionnaire on Gastrointestinal characteristics
Time frame: 4 weeks
Questionnaire on Participant Assessment of Constipation Quality of Life (PAC-QoL)
Time frame: 4 weeks
Faecal microbiota composition determined by illumina sequencing
Time frame: 4 weeks
Stool metabolite profiling determined by GC/LC-MS
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2015.
- Derived from this study: PubMed 28213610Vandeputte 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.
- Derived from this study: PubMed 27492975Micka 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Menzel, MD principal investigator
BioTeSys GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orafti® Inulin in people with Healthy and Constipation, run by Beneo GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool frequency determined by daily questionnaire (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02548247, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2015.