Ulcerative ColitisNCT07520461
Microbiome-targeted Diet Therapy in Ulcerative Colitis
A study testing High Protein, High Fiber (HPHF) Diet in people with Ulcerative Colitis, run by University of Minnesota at 1 site in United States.
Trial summary
The central objective of this proposal is to test a novel diet capable of meeting the elevated protein requirements in ulcerative colitis (UC), while simultaneously decreasing microbial hydrogen sulfide (H2S) production in the colon with fiber. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- High Protein, High Fiber (HPHF) Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2026to 1 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability and willingness to provide informed consent
- Age at least 18 years old
- Diagnosis of UC based on clinical and endoscopic criteria
- UC duration of at least 3 months
- Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score ≤4 within 90 days of randomization
- On a stable dose or no existing UC therapies (apart from steroids) for defined periods (as outlined below).
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- ≥4 weeks if no medication, 5-ASA
- ≥8 wk for immunomodulatory therapy
- ≥12 wk for biologics
- Ability to comply with study requirements in the opinion of the primary investigator
Who cannot join
- Moderate or severe UC as defined by UCEIS ≥5
- History of stomach surgery or bowel resection
- Antibiotic use within 3 months
- Anticipated antibiotic exposure during the study period (e.g. perioperative antibiotics)
- Pregnancy or breastfeeding
- History of anaphylactic food allergies
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- Intolerance of high dietary fiber content
- Ongoing alcohol or drug abuse
- Habitual vegan diet pattern
- Insufficient freezer space to accommodate meal delivery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Of Minnesota
Minneapolis, Minnesota, 55455
Levi Teigen
About this study
The central objective of this proposal is to test a novel diet capable of meeting the elevated protein requirements in ulcerative colitis (UC), while simultaneously decreasing microbial hydrogen sulfide (H2S) production in the colon with fiber.
- Conditions
- Ulcerative Colitis
- Being tested
- High Protein, High Fiber (HPHF) Diet
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Protein, High Fiber (HPHF) DietOther
The HPHF diet is a diet designed to maximize the intake of proteins and fermentable dietary fibers. Frozen meals are provided to participants weekly and consumed over two non-consecutive 7-day periods.
| Study group | Role | What they receive |
|---|---|---|
| On-Off Cycling Intervention | Experimental | 1 week standard diet, followed by
1 week high-protein, high-fiber diet, followed by
1 week standard diet, followed by
1 week high-protein, high-fiber diet Receives: Other: High Protein, High Fiber (HPHF) Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal H2S Production
Assessed from stool samples
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start9 Nov 2026 (estimated)
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Levi Teigen, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520461
- Sponsor's protocol ID
- GI-2026-34620
- Status last verified
- Oct 2026
- First submitted
- 2 Apr 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome-targeted Diet Therapy in Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT07520461
- Acronym / sponsor ID
- GI-2026-34620
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 9 Nov 2026 (estimated)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 9 Apr 2026 (actual)
- 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 central objective of this proposal is to test a novel diet capable of meeting the elevated protein requirements in ulcerative colitis (UC), while simultaneously decreasing microbial hydrogen sulfide (H2S) production in the colon with fiber.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| On-Off Cycling Intervention | Experimental | Other: High Protein, High Fiber (HPHF) Diet1 week standard diet, followed by 1 week high-protein, high-fiber diet, followed by 1 week standard diet, followed by 1 week high-protein, high-fiber diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Ability and willingness to provide informed consent
- Age at least 18 years old
- Diagnosis of UC based on clinical and endoscopic criteria
- UC duration of at least 3 months
- Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score ≤4 within 90 days of randomization
Key exclusion criteria (10 listed)
- Moderate or severe UC as defined by UCEIS ≥5
- History of stomach surgery or bowel resection
- Antibiotic use within 3 months
- Anticipated antibiotic exposure during the study period (e.g. perioperative antibiotics)
- Pregnancy or breastfeeding
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 |
|---|---|---|
| High Protein, High Fiber (HPHF) DietThe HPHF diet is a diet designed to maximize the intake of proteins and fermentable dietary fibers. Frozen meals are provided to participants weekly and consumed over two non-consecutive 7-day periods. | Other | On-Off Cycling Intervention |
Primary outcome
Fecal H2S Production
Time frame: Week 4
Assessed from stool samples
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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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.
Levi Teigen principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Protein, High Fiber (HPHF) Diet in people with Ulcerative Colitis, run by University of Minnesota 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 10 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 20 Oct 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lulu Chen (612-301-8294, chen8124@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal H2S Production (time frame: Week 4). 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 20 Oct 2026.