Microbiome-targeted Diet Therapy in Ulcerative Colitis
ConditionUlcerative Colitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Minnesota
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Crossover
Treatments tested in this trial
High Protein, High Fiber (HPHF) Diet
Other interventionThe 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: On-Off Cycling InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Fecal H2S Production
Assessed from stool samples
Time frame
Week 4Sponsors and contacts
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Source ClinicalTrials.gov