Using Breath Tests to Study Gut Sulfur Changes During Dietary Therapy
Not applicable · Testing Elemental formula (mBiota Elemental, Good LFE, Santa Monica, CA), Reduced Sulfur diet and… · 1 site · University of British Columbia
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Elemental formula (mBiota Elemental, Good LFE, Santa Monica, CA) (a dietary supplement), Reduced Sulfur diet (a behavioral program) and Habitual Diet (a behavioral program) as a possible treatment. Condition(s) listed: Ulcerative Colitis (UC).
Participants are assigned to groups by chance (randomized).
It is single-blind: participants do not know which group they are in.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 19 to 70
- Any sex
Some of the main requirements, copied from the record:
- Age 19-70 years.
- =Diagnosis of mild-to-moderate ulcerative colitis, defined by a partial Mayo score (pMayo) of 2-7.
- Evidence of active inflammation at enrollment, defined as:
Plus 5 more requirement(s). There are also 23 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 45 participants are expected to take part.
- Start date: 2026-06-01 (planned).
- Main results expected around 2029-03-01 (estimate from the record).
- 1 study site listed in Canada.
Main thing being measured
- Composite clinical and biochemical response (Baseline, Week 2 and week 12)
In the researchers’ words
This study aims to test whether a short liquid-based diet, followed by a low-sulfur eating plan, is safe, manageable, and helpful for people with mild to moderate ulcerative colitis. Investigators want to see if this approach can improve gut health, lower inflammation, and reduce symptoms.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis (UC) |
| Lead sponsor | University of British Columbia |
| Collaborators | University of Calgary |
| Enrollment | 45 (estimated) |
| Start date | 2026-06-01 |
| Primary completion (est.) | 2029-03-01 |
| First posted | 2026-06-11 |
| Last updated | 2026-06-11 |
| Official title | Sulfur on the Breath: Using Breath Biomarkers to Monitor Gut Microbial Sulfur Metabolism During Elemental and Reduced Sulfur Dietary Therapy |
| ClinicalTrials.gov ID | NCT07640659 |
Interventions
- Elemental formula (mBiota Elemental, Good LFE, Santa Monica, CA) (Dietary Supplement)
Elemental liquid diets (EDs) are a subset of Exclusive Enteral Nutrition (EEN). Similar to EEN, they are nutritionally complete formulas, but differ in that they consist of free amino acids, monosaccharides, and fatty acids instead of whole, intact macronutrients, which are designed for optimal digestibility and to minimize antigenicity. EDs have been shown to reduce immune activation, favourably … - Reduced Sulfur diet (Behavioral)
This diet excludes high sulfur foods (e.g., red meat, seafood, eggs), cruciferous vegetables, dried fruits, and fermented beverages. It also accounts for sulfate intake from drinking water and processed food additives. - Habitual Diet (Behavioral)
Participants randomized to the comparator group will continue their usual dietary intake for 10 weeks without specific dietary restrictions.
Full eligibility criteria (from the record)
Inclusion Criteria: * Age 19-70 years. =Diagnosis of mild-to-moderate ulcerative colitis, defined by a partial Mayo score (pMayo) of 2-7. * Evidence of active inflammation at enrollment, defined as: * C-reactive protein (CRP) > 5 mg/L; or * Fecal calprotectin (FCP) > 200 µg/g. * Receiving stable medical therapy for ulcerative colitis for at least 8 weeks prior to enrollment. * No corticosteroid use at the time of recruitment. * Under consideration by the treating physician for treatment escalation or biologic switch due to inadequate response to current therapy. Exclusion Criteria: * Partial Mayo score (pMayo) > 7. * Pregnant or breastfeeding. * Body mass index (BMI) < 18 kg/m². * History of an eating disorder. * Severe psychiatric disorder. * Severe medical conditions, including: * Active cancer; * Significant cardiovascular disease; * Diabetes mellitus; or * Severe food allergies. * Known allergy or intolerance to corn, dextrose, or maltodextrin. * Antibiotic use within 3 months prior to enrollment. * Probiotic use within 3 months prior to enrollment. * Use of herbal anti-inflammatory supplements during the study period, including but not limited to: * Serrapeptidase; * Curcumin; * Boswellia; or * Bromelain. * History of major gastrointestinal surgery, including: * Ostomy; * Total colectomy; or * Short bowel syndrome. * Inability or unwillingness to comply with study procedures, including anticipated travel or other commitments that may interfere with participation.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University of British Columbia-Okanagan | Kelowna, British Columbia | Canada |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.