Using Breath Tests to Study Gut Sulfur Changes During Dietary Therapy
ConditionUlcerative Colitis (UC)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-70
SponsorUniversity of British Columbia
About this trial
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. Investigators will also test breath samples as an easy, non-invasive way to track gut bacteria activity and disease changes. Investigators believe this diet plan can reduce harmful gut bacteria that produce irritating sulfur compounds, leading to better gut health and measurable improvements that can be detected through breath testing.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 19-70 years.
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.
Disqualifiers
Partial Mayo score (pMayo) > 7.
Pregnant or breastfeeding.
Body mass index (BMI) < 18 kg/m².
History of an eating disorder.
Trial design
Design model
Parallel
Treatments tested in this trial
Elemental formula (mBiota Elemental, Good LFE, Santa Monica, CA)
Dietary supplementElemental 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 modulate the microbiota, suppress proinflammatory cytokines, support epithelial repair, and exclude common dietary additives that may provoke inflammation.
Reduced Sulfur diet
BehavioralThis 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
BehavioralParticipants randomized to the comparator group will continue their usual dietary intake for 10 weeks without specific dietary restrictions.
Treatment groups
45 Participants
are divided into 2 treatment groupsGroup A: Reduced Sulfur DietExperimental treatment 2 interventions
Group B: Habitual DietActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Composite clinical and biochemical response
Composite clinical and biochemical response at week 12, defined as \>30% and \>1-point reduction in pMayo score from baseline, plus rectal bleeding subscore decrease of \>1 or an absolute subscore \<1, with fecal calprotectin \<250 μg/g and CRP \<5 mg/L.
Time frame
Baseline, Week 2 and week 12Secondary outcomes
1
Stool Biomarkers
fecal calprotectin, shotgun metagenomics (microbiome composition, sulfur metabolizing bacteria), and targeted metabolomics (e.g., hydrogen sulfide, thiosulfate)
Time frame
Baseline, week 2 and week 122
C-Reactive Protein (CRP) concentration
Serum CRP concentration will be measured to assess systemic inflammation.
Time frame
Baseline, week 2 and week 123
Complete Blood Count (CBC) parameters
CBC parameters, including hemoglobin, white blood cell count, platelet count, and differential counts, will be measured.
Time frame
Baseline, week 2 and week 124
Serum inflammatory biomarker concentrations
Serum concentrations of IL-6, TNF-α, MCP-1, and LBP will be measured individually and reported separately.
Time frame
Baseline, week 2 and week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of British Columbia
Lead sponsor
University of Calgary
Collaborator
Source ClinicalTrials.gov
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