HypomotilityPhase 3NCT02194972
Clinical Effects of Soluble Dietary Fiber Supplementation
A Phase 3 study testing Pectin in people with Hypomotility and Constipation, run by Nanjing PLA General Hospital.
Trial summary
The purpose of this study is to investigate the effect of pectin, a kind of soluble dietary fiber, on colonic transit time, clinical symptoms and the gut microbiota in adults with slow-transit constipation. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Hypomotility, Constipation
- What is being tested?
- Pectin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Oct 2012
- Phase
- Phase 3
- 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 18 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients(age≧18y)
- Admitted for slow-transit constipation were considered eligible
Who cannot join
- Mental disorders
- Cancer
- Inflammatory bowel disease
About this study
Official title: Study of Soluble Dietary Fiber on Colonic Transit Time and Clinical Symptoms in Adults With Slow-transit Constipation
The purpose of this study is to investigate the effect of pectin, a kind of soluble dietary fiber, on colonic transit time, clinical symptoms and the gut microbiota in adults with slow-transit constipation.
Read the detailed description
Patients were randomized to receive either pectin or placebo. Treatment consisted of 4 weeks supplementation with pectin (fiber group) or placebo. We evaluated the colonic transit time, constipation symptoms and fecal bacterial population in two groups.
- Conditions
- Hypomotility, Constipation
- Being tested
- Pectin
- Keywords
- constipation, colon transit time, gut microbiota, soluble dietary fiber, disturbance of gut microbiota in constipation
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PectinDrug
Also called soluble dietary fiber
pectin （Andeli Ltd. Yantai, China）, 24g/d for 4weeks
| Study group | Role | What they receive |
|---|---|---|
| soluble dietary fiber | Experimental | pectin, a kind of soluble dietary fiber Receives: Drug: Pectin |
| Placebo | No intervention | Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy: intestinal transit time
colonic transit time
Measured: four weeks after inclusion
Secondary outcomes (2)
efficacy: clinical symptoms
Wexner constipation score
Measured: four weeks after inclusion
efficacy: gut microbiota
real-time PCR
Measured: four weeks after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startMay 2009
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypomotilityStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao Tao, Nanjing PLA General Hospital
- Investigators
- Tao Gao, M.D., Principal investigator, Nanjing PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02194972
- Sponsor's protocol ID
- 2011NLY42
- Status last verified
- Jul 2014
- First submitted
- 17 Jul 2014
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Soluble Dietary Fiber on Colonic Transit Time and Clinical Symptoms in Adults With Slow-transit Constipation
- ClinicalTrials.gov ID
- NCT02194972
- Acronym / sponsor ID
- 2011NLY42
- Conditions
- Hypomotility, Constipation
- Keywords
- constipation, colon transit time, gut microbiota, soluble dietary fiber, disturbance of gut microbiota in constipation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Nanjing PLA General HospitalUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 21 Jul 2014 (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.
The purpose of this study is to investigate the effect of pectin, a kind of soluble dietary fiber, on colonic transit time, clinical symptoms and the gut microbiota in adults with slow-transit constipation.
Detailed description
Patients were randomized to receive either pectin or placebo. Treatment consisted of 4 weeks supplementation with pectin (fiber group) or placebo. We evaluated the colonic transit time, constipation symptoms and fecal bacterial population in two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| soluble dietary fiber | Experimental | Drug: Pectinpectin, a kind of soluble dietary fiber |
| Placebo | No intervention | –Placebo |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients(age≧18y)
- Admitted for slow-transit constipation were considered eligible
Key exclusion criteria (3 listed)
- Mental disorders
- Cancer
- Inflammatory bowel disease
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 |
|---|---|---|
| PectinAlso: soluble dietary fiberpectin （Andeli Ltd. Yantai, China）, 24g/d for 4weeks | Drug | soluble dietary fiber |
Primary outcome
efficacy: intestinal transit time
Time frame: four weeks after inclusion
colonic transit time
2 secondary outcomes
efficacy: clinical symptoms
Time frame: four weeks after inclusion
efficacy: gut microbiota
Time frame: four weeks after inclusion
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 24 Aug 2018.
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.
Tao Gao, M.D. principal investigator
Nanjing PLA General Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pectin in people with Hypomotility and Constipation, run by Nanjing PLA General Hospital.
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 2 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 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
efficacy: intestinal transit time (time frame: four weeks after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2018; AzTrials last refreshed its copy on 7 Nov 2026.