Irritable Bowel SyndromePhase 3NCT02270268
Effects of Pectin Supplementation in Diarrhea-predominant Irritable Bowel Syndrome
A Phase 3 study testing Pectin and maltodextrin in people with Irritable Bowel Syndrome, 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 clinical symptoms, gut microbiota and the immune status in patients with diarrhea-predominant irritable bowel syndrome Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Pectin and maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Oct 2013
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients(age≧18y)
- Admitted for diarrhea-predominant irritable bowel syndrome
Who cannot join
- Mental disorders
- Cancer
- Inflammatory bowel disease
About this study
Official title: Therapeutic Effects of Pectin Supplementation in Patients With Diarrhea-predominant Irritable Bowel Syndrome
The purpose of this study is to investigate the effect of pectin, a kind of soluble dietary fiber, on clinical symptoms, gut microbiota and the immune status in patients with diarrhea-predominant irritable bowel syndrome
Read the detailed description
Patients were randomized to receive either pectin or placebo. Treatment consisted of 6 weeks supplementation with pectin (fiber group) or placebo (maltodextrin). We evaluated the clinical symptoms, gut microbiota and the immune markers in two groups.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Pectin, maltodextrin
- Keywords
- Irritable bowel syndrome, Gut microbiota, Soluble dietary fiber
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PectinDietary supplement
Pectin （Andeli Ltd. Yantai, China）, 24g/d for six weeks
maltodextrinDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| pectin | Experimental | a kind of soluble dietary fiber Receives: Dietary Supplement: Pectin |
| Placebo | Placebo comparator | maltodextrin Receives: Dietary Supplement: maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy: change of stool frequency, faecal form and clinical symptoms score
change from baseline in stool frequency, faecal form (Bristol stool scale) and clinical symptoms score (7-point Likert scale) at six weeks
Measured: six weeks after inclusion
Secondary outcomes (2)
efficacy: gut microbiota
real-time PCR
Measured: six weeks after inclusion
efficacy: cytokine ratios
Cytokine production
Measured: six 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 Oct 2014 (estimated)
- Study startNov 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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
- 114 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
- NCT02270268
- Sponsor's protocol ID
- 2011NLY073
- Status last verified
- Mar 2016
- First submitted
- 10 Oct 2014
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of Pectin Supplementation in Patients With Diarrhea-predominant Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT02270268
- Acronym / sponsor ID
- 2011NLY073
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable bowel syndrome, Gut microbiota, Soluble dietary fiber
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Nanjing PLA General HospitalUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 21 Oct 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 clinical symptoms, gut microbiota and the immune status in patients with diarrhea-predominant irritable bowel syndrome
Detailed description
Patients were randomized to receive either pectin or placebo. Treatment consisted of 6 weeks supplementation with pectin (fiber group) or placebo (maltodextrin). We evaluated the clinical symptoms, gut microbiota and the immune markers 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 |
|---|---|---|
| pectin | Experimental | Dietary Supplement: Pectina kind of soluble dietary fiber |
| Placebo | Placebo comparator | Dietary Supplement: maltodextrinmaltodextrin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients(age≧18y)
- Admitted for diarrhea-predominant irritable bowel syndrome
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 |
|---|---|---|
| PectinPectin （Andeli Ltd. Yantai, China）, 24g/d for six weeks | Dietary supplement | pectin |
| maltodextrin | Dietary supplement | Placebo |
Primary outcome
efficacy: change of stool frequency, faecal form and clinical symptoms score
Time frame: six weeks after inclusion
change from baseline in stool frequency, faecal form (Bristol stool scale) and clinical symptoms score (7-point Likert scale) at six weeks
2 secondary outcomes
efficacy: gut microbiota
Time frame: six weeks after inclusion
efficacy: cytokine ratios
Time frame: six 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 Mar 2016.
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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.
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 and maltodextrin in people with Irritable Bowel Syndrome, 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 Mar 2016. 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. 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.
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: change of stool frequency, faecal form and clinical symptoms score (time frame: six 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 Mar 2016.