ClinicalTrials.gg
RecruitingNCT07520461Updated Nov 9, 2026

Microbiome-targeted Diet Therapy in Ulcerative Colitis

An interventional study of High Protein, High Fiber (HPHF) Diet in Ulcerative Colitis, sponsored by University of Minnesota. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by University of Minnesota · Not applicable, Interventional, and Treatment

Updated Nov 9, 2026Start date movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Ulcerative Colitis

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03

In context

Colitis, Ulcerative

1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.

This study's planned enrollment of 40 is below the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.

Browse Colitis, Ulcerative studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.

Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Ability and willingness to provide
  • 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 ) for defined periods (as outlined below).

    1. ≥4 weeks if no medication, 5-ASA
    2. ≥8 wk for immunomodulatory therapy
    3. ≥12 wk for biologics
  • Ability to comply with study requirements in the opinion of the primary investigator

Exclusion criteria

Exclusion Criteria:

  • 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
  • Intolerance of high dietary fiber content
  • Ongoing alcohol or drug abuse
  • Habitual vegan diet pattern
  • Insufficient freezer space to accommodate meal delivery
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    On-Off Cycling Intervention

    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

    Other: High Protein, High Fiber (HPHF) Diet

Interventions

  • OtherHigh Protein, High Fiber (HPHF) Diet

    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.

06

What researchers measure

Primary outcomes

  1. Fecal H2S Production

    Assessed from stool samples

    Time frame: Week 4

07

Study locations

1 of 1 sites recruiting
08

Updates

3 registry updates since Sep 25, 2026
Start date
Sep 26, 2026→Nov 4, 2026
moved 3 times, Oct 6, 2026 – Nov 9, 2026
Show all 3 updates
  1. Nov 9, 2026
    Start date Nov 9, 2026→Nov 4, 2026
    + 1 other change: verification date
  2. Oct 20, 2026
    Start date Oct 15, 2026→Nov 9, 2026
  3. Oct 6, 2026
    Start date Sep 26, 2026→Oct 15, 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07520461
Responsible party
Sponsor
First posted
Apr 9, 2026
Start date
Nov 4, 2026 (estimated)
Primary completion
Jun 1, 2029 (estimated)
Completion
Jun 1, 2029 (estimated)
Last update
Nov 9, 2026

Study contacts

Lulu Chen
Contact
chen8124@umn.edu
612-301-8294
Levi Teigen
principal investigator · University of Minnesota

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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