PouchitisPhase 1NCT02203955
Study of Sc-FOS for Pouchitis Prevention
A Phase 1 study testing Short-Chain Fructooligosaccharide and Maltodextrin in people with Pouchitis, run by Mayo Clinic at 1 site in United States.
Trial summary
The main objective is to compare prebiotic therapy with placebo for the prevention of pouchitis after closure of diverting ileostomy in patients with an ileal pouch anal anastomosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pouchitis
- What is being tested?
- Short-Chain Fructooligosaccharide and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Dec 2018
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years.
- History of ulcerative colitis
- Ileostomy closure after IPAA
- Ability to give appropriate consent
Who cannot join
- Crohn's disease.
- Perianal disease (including abscess, fissure, or stricture)
- Pregnancy
- Lactation
- Concurrent treatment for IBD or pouchitis
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Prevention of Pouchitis With Short-Chain Fructooligosaccharide Therapy, A Double-Blind, Placebo-Controlled Trial
The main objective is to compare prebiotic therapy with placebo for the prevention of pouchitis after closure of diverting ileostomy in patients with an ileal pouch anal anastomosis. This study will also characterize the effects of prebiotics on the fecal microbiota and fecal microbial metabolites and correlate these effects with the primary outcome of development of pouchitis.
- Conditions
- Pouchitis
- Being tested
- Short-Chain Fructooligosaccharide, Maltodextrin
- Medical subject headings
- Pouchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-Chain FructooligosaccharideDrug
4 chews (8.0 g scFOS) orally for 12 months
MaltodextrinDrug
4 chews (maltodextrin) daily for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Short-Chain Fructooligosaccharide | Active comparator | 4 chews (8.0 g scFOS) orally per day for 12 months Receives: Drug: Short-Chain Fructooligosaccharide |
| Maltodextrin | Placebo comparator | 4 chews (maltodextrin) daily for 12 months Receives: Drug: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Pouchitis Disease Activity Index (PDAI) at One Year
In the PDAI, an overall score is calculated from three separate six-point scales comprising of clinical symptoms, endoscopic findings and histological changes. The PDAI incorporates histological features of acute inflammation, and establishes a cut-off of seven for differentiation between 'pouchitis (≥7 points) and 'no pouchitis' (<7 points).
Measured: baseline, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PouchitisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura E. Raffals, M.D, Mayo Clinic
- Investigators
- Laura Raffals, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02203955
- Sponsor's protocol ID
- 14-001220
- Status last verified
- Feb 2020
- First submitted
- 16 Jul 2014
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Pouchitis With Short-Chain Fructooligosaccharide Therapy, A Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT02203955
- Acronym / sponsor ID
- 14-001220
- Conditions
- Pouchitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 30 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 main objective is to compare prebiotic therapy with placebo for the prevention of pouchitis after closure of diverting ileostomy in patients with an ileal pouch anal anastomosis. This study will also characterize the effects of prebiotics on the fecal microbiota and fecal microbial metabolites and correlate these effects with the primary outcome of development of pouchitis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short-Chain Fructooligosaccharide | Active comparator | Drug: Short-Chain Fructooligosaccharide4 chews (8.0 g scFOS) orally per day for 12 months |
| Maltodextrin | Placebo comparator | Drug: Maltodextrin4 chews (maltodextrin) daily for 12 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years.
- History of ulcerative colitis
- Ileostomy closure after IPAA
- Ability to give appropriate consent
Key exclusion criteria (5 listed)
- Crohn's disease.
- Perianal disease (including abscess, fissure, or stricture)
- Pregnancy
- Lactation
- Concurrent treatment for IBD or pouchitis
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 |
|---|---|---|
| Short-Chain Fructooligosaccharide4 chews (8.0 g scFOS) orally for 12 months | Drug | Short-Chain Fructooligosaccharide |
| Maltodextrin4 chews (maltodextrin) daily for 12 months | Drug | Maltodextrin |
Primary outcome
Mean Change in Pouchitis Disease Activity Index (PDAI) at One Year
Time frame: baseline, 1 year
In the PDAI, an overall score is calculated from three separate six-point scales comprising of clinical symptoms, endoscopic findings and histological changes. The PDAI incorporates histological features of acute inflammation, and establishes a cut-off of seven for differentiation between 'pouchitis (≥7 points) and 'no pouchitis' (<7 points).
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 Feb 2020.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Pouchitis
Active, not recruitingPhase 4
Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch
Pouchitis, Pouches, Ileoanal
RecruitingPhase 4
Rifaximin for the Secondary Prevention of Recurrent Pouchitis
Pouchitis
Not yet recruitingEarly Phase 1
Oral Aeromonas sp. MTB Phage Therapy for Pouchitis in Patients With Ulcerative Colitis (UC)
Pouchitis, UC - Ulcerative Colitis
RecruitingPhase 2
Etrasimod as Prevention of Pouchitis
Pouchitis
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
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.
Laura Raffals, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Short-Chain Fructooligosaccharide and Maltodextrin in people with Pouchitis, run by Mayo Clinic at 1 site in United States.
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 4 inclusion and 5 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 Feb 2020. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Mean Change in Pouchitis Disease Activity Index (PDAI) at One Year (time frame: baseline, 1 year). 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 Feb 2020.