Ulcerative Colitis (UC)Sulfur-UCNCT07640659
Using Breath Tests to Study Gut Sulfur Changes During Dietary Therapy
A study testing Elemental formula (mBiota Elemental, Good LFE, Santa Monica, CA), Reduced Sulfur diet and Habitual Diet in people with Ulcerative Colitis (UC), run by University of British Columbia at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Ulcerative Colitis (UC)
- What is being tested?
- Elemental formula (mBiota Elemental, Good LFE, Santa Monica, CA), Reduced Sulfur diet and Habitual Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2026to 31 Dec 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 23Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
University of British Columbia-Okanagan
Kelowna, British Columbia, V1V 1V7
Natasha Haskey, RD, PhD, 250-807-9597, natasha.haskey@ubc.ca
Natasha Haskey, RD, PhD
About this study
Official title: Sulfur on the Breath: Using Breath Biomarkers to Monitor Gut Microbial Sulfur Metabolism During Elemental and Reduced Sulfur Dietary Therapy
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.
Read the detailed description
Purpose To determine whether a short-term elemental diet followed by a reduced sulfur diet is a safe, tolerable, and effective non-pharmacologic strategy to improve clinical outcomes, reduce inflammation, and beneficially modulate the gut microbiome in adults with mild-to-moderate ulcerative colitis. A secondary purpose is to validate breath-based biomarkers as non-invasive tools to monitor sulfur metabolism and disease activity. Breath biomarkers include volatile organic compounds (VOCs) and exhaled breath condensate (EBC) to assess sulfur-related metabolites.
Hypothesis A 2-week elemental diet followed by a 10-week reduced sulfur diet will reduce intestinal inflammation and improve clinical outcomes by shifting the gut microbiome away from pro-inflammatory, sulfur-metabolizing bacteria, resulting in reduced sulfur metabolite production detectable through exhaled volatile organic compounds and exhaled breath condensate.
Justification Despite advances in biologic therapies, many UC patients fail to achieve sustained remission, and current treatments do not address upstream drivers such as diet-microbiome interactions. Elemental diets have demonstrated efficacy in Crohn's disease but remain understudied in UC. Emerging evidence links dietary sulfur, microbial sulfur metabolism, and toxic metabolites to UC pathogenesis. This study addresses critical gaps by testing a feasible dietary intervention and validating non-invasive breath biomarkers for real-time disease monitoring and precision nutrition.
Objectives
- Evaluate the clinical efficacy, safety, and feasibility of an elemental diet followed by an reduced sulfur diet.
- Characterize changes in gut microbiome composition, inflammatory markers, and sulfur-related metabolic outputs.
- Validate breath-based volatile organic compounds and exhaled breath condensate as biomarkers of sulfur metabolism and treatment response.
- Identify microbial and metabolic signatures predictive of dietary response.
Research Design A prospective, randomized, controlled trial in adults with mild-to-moderate UC. All participants complete a 2-week elemental diet, followed by randomization (2:1) to either a reduced sulfur diet group (intervention group) or return to habitual diet group (control group) for 10 weeks. Clinical indices, inflammatory biomarkers, stool microbiome profiles and breath samples are collected longitudinally. The initial 2-week elemental diet is applied uniformly to standardize baseline microbial and metabolic conditions prior to randomization and does not replace or delay clinical care decisions.
Statistical Analysis Primary outcomes will be assessed using within- and between-group comparisons of clinical and biochemical response at week 12. Microbiome and metabolomic data will be analyzed using multivariate and differential abundance methods. Correlations between breath biomarkers, microbiome features, and clinical outcomes will assess sensitivity and specificity.
- Conditions
- Ulcerative Colitis (UC)
- Being tested
- Elemental formula (mBiota Elemental, Good LFE, Santa Monica, CA), Reduced Sulfur diet, Habitual Diet
- Keywords
- Ulcerative colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 modulate the microbiota, suppress proinflammatory cytokines, support epithelial repair, and exclude common dietary additives that may provoke inflammation.
Reduced Sulfur dietBehavioural
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 DietBehavioural
Participants randomized to the comparator group will continue their usual dietary intake for 10 weeks without specific dietary restrictions.
| Study group | Role | What they receive |
|---|---|---|
| Reduced Sulfur Diet | Experimental | Participants will consume a novel elemental formula (mBiota Elemental, Good LFE, Santa Monica, CA) as their sole source of nutrition for two weeks. followed by a 10-week reduced sulfur diet. The reduced sulfur diet is designed to limit dietary sources of sulfur-containing compounds that may contribute to hydrogen sulfide production by the gut microbiota. Receives: Dietary Supplement: Elemental formula (mBiota Elemental, Good LFE, Santa Monica, CA); Behavioral: Reduced Sulfur diet |
| Habitual Diet | Active comparator | Participants will complete a 2-week elemental diet intervention followed by a 10-week habitual diet. Participants will be instructed to resume and maintain their usual dietary intake without specific sulfur-restriction recommendations. Receives: Dietary Supplement: Elemental formula (mBiota Elemental, Good LFE, Santa Monica, CA); Behavioral: Habitual Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 2 and week 12
Secondary outcomes (11)
Stool Biomarkers
fecal calprotectin, shotgun metagenomics (microbiome composition, sulfur metabolizing bacteria), and targeted metabolomics (e.g., hydrogen sulfide, thiosulfate)
Measured: Baseline, week 2 and week 12
C-Reactive Protein (CRP) concentration
Serum CRP concentration will be measured to assess systemic inflammation.
Measured: Baseline, week 2 and week 12
Complete Blood Count (CBC) parameters
CBC parameters, including hemoglobin, white blood cell count, platelet count, and differential counts, will be measured.
Measured: Baseline, week 2 and week 12
Serum inflammatory biomarker concentrations
Serum concentrations of IL-6, TNF-α, MCP-1, and LBP will be measured individually and reported separately.
Measured: Baseline, week 2 and week 12
Breath Biomarkers
Volatile Organic Compounds (VOCs) and exhaled breath condensate (EBC) to assess sulfur-containing metabolites and host-microbiota interactions
Measured: Baseline, week 2 and week 12
Adherence to the Elemental Diet and Reduced Sulfur Diet Intervention
Adherence to the ED intervention will be assessed using a modified Medication Adherence Report Scale questionnaire at each visit, as well as through compliance phone calls and food diaries. Poor adherence will be defined as meeting at least one of the following three criteria:
- intolerance, indicated by discontinuation of dietary therapy due to the patient's refusal to continue; or
- low adherence scores (score of 0-1) reported on the modified Medication Adherence Report Scale; and
- collect the empty mBiota containers as a measure of adherence. Adherence to the RS diet will be assessed through food recalls collected via ASA-24.
Adverse events (AEs) will be systematically collected throughout the study using a combination of participant self-reporting, scheduled assessments, and clinical monitoring.
Measured: Baseline, week 2 and week 12
Change in Quality of Life
Health-related quality of life will be measured using the 12-item short form-12 (SF-12). The SF-12 comprises two components: physical health and mental health. Scores range from 0 to 100, where 0 indicates the lowest level of health and 100 the highest.
Measured: Baseline, week 2 and week 12
Change in Anxiety
Anxiety will be assessed by the GAD-7 (Generalized Anxiety Disorder-7). It is a self-reported screening tool used to measure the severity of generalized anxiety disorder (GAD) symptoms over the past two weeks. The total score ranges from 0 to 21. A score of 10 or higher typically indicates clinically significant anxiety and suggests the need for further evaluation or intervention..
Measured: Baseline, week 2 and week 12
Change in Depression
Depression levels will be assessed by PHQ-8 (Patient Health Questionnaire-8). It is a widely used self-report screening tool for assessing the severity of depressive symptoms over the past two weeks. The total score is the sum of all item responses, ranging from 0 to 24. A score of 10 or higher indicates the presence of clinically significant depressive symptoms and suggests the need for further evaluation or intervention.
Measured: Baseline, week 2 and week 12
Change in Weight
Body weight will be measured in kilograms (kg)
Measured: Baseline, week 2 and week 12
Change in Body Mass Index (BMI)
BMI will be calculated as weight (kg) divided by height squared (m²).
Measured: Baseline, week 2 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Mar 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary
- Responsible party
- Principal investigator, Natasha Haskey, University of British Columbia
- Investigators
- Natasha Haskey, RD, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640659
- Sponsor's protocol ID
- H26-00017
- Other IDs
- POP25-11968
- Acronym
- Sulfur-UC
- Status last verified
- Jun 2026
- First submitted
- 29 May 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD used in the results of the publication will be shared
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- Sulfur-UC / H26-00017
- Conditions
- Ulcerative Colitis (UC)
- Keywords
- Ulcerative colitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- University of Calgary
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 11 Jun 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.
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.
Detailed description
Purpose To determine whether a short-term elemental diet followed by a reduced sulfur diet is a safe, tolerable, and effective non-pharmacologic strategy to improve clinical outcomes, reduce inflammation, and beneficially modulate the gut microbiome in adults with mild-to-moderate ulcerative colitis. A secondary purpose is to validate breath-based biomarkers as non-invasive tools to monitor sulfur metabolism and disease activity. Breath biomarkers include volatile organic compounds (VOCs) and exhaled breath condensate (EBC) to assess sulfur-related metabolites.
Hypothesis A 2-week elemental diet followed by a 10-week reduced sulfur diet will reduce intestinal inflammation and improve clinical outcomes by shifting the gut microbiome away from pro-inflammatory, sulfur-metabolizing bacteria, resulting in reduced sulfur metabolite production detectable through exhaled volatile organic compounds and exhaled breath condensate.
Justification Despite advances in biologic therapies, many UC patients fail to achieve sustained remission, and current treatments do not address upstream drivers such as diet-microbiome interactions. Elemental diets have demonstrated efficacy in Crohn's disease but remain understudied in UC. Emerging evidence links dietary sulfur, microbial sulfur metabolism, and toxic metabolites to UC pathogenesis. This study addresses critical gaps by testing a feasible dietary intervention and validating non-invasive breath biomarkers for real-time disease monitoring and precision nutrition.
Objectives
- Evaluate the clinical efficacy, safety, and feasibility of an elemental diet followed by an reduced sulfur diet.
- Characterize changes in gut microbiome composition, inflammatory markers, and sulfur-related metabolic outputs.
- Validate breath-based volatile organic compounds and exhaled breath condensate as biomarkers of sulfur metabolism and treatment response.
- Identify microbial and metabolic signatures predictive of dietary response.
Research Design A prospective, randomized, controlled trial in adults with mild-to-moderate UC. All participants complete a 2-week elemental diet, followed by randomization (2:1) to either a reduced sulfur diet group (intervention group) or return to habitual diet group (control group) for 10 weeks. Clinical indices, inflammatory biomarkers, stool microbiome profiles and breath samples are collected longitudinally. The initial 2-week elemental diet is applied uniformly to standardize baseline microbial and metabolic conditions prior to randomization and does not replace or delay clinical care decisions.
Statistical Analysis Primary outcomes will be assessed using within- and between-group comparisons of clinical and biochemical response at week 12. Microbiome and metabolomic data will be analyzed using multivariate and differential abundance methods. Correlations between breath biomarkers, microbiome features, and clinical outcomes will assess sensitivity and specificity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced Sulfur Diet | Experimental | Dietary Supplement: Elemental formula (mBiota Elemental, Good LFE, Santa Monica, CA), Behavioral: Reduced Sulfur dietParticipants will consume a novel elemental formula (mBiota Elemental, Good LFE, Santa Monica, CA) as their sole source of nutrition for two weeks. followed by a 10-week reduced sulfur diet. The reduced sulfur diet is designed to limit dietary sources of sulfur-containing compounds that may contribute to hydrogen sulfide production by the gut microbiota. |
| Habitual Diet | Active comparator | Dietary Supplement: Elemental formula (mBiota Elemental, Good LFE, Santa Monica, CA), Behavioral: Habitual DietParticipants will complete a 2-week elemental diet intervention followed by a 10-week habitual diet. Participants will be instructed to resume and maintain their usual dietary intake without specific sulfur-restriction recommendations. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (23 listed)
- Partial Mayo score (pMayo) > 7.
- Pregnant or breastfeeding.
- Body mass index (BMI) < 18 kg/m².
- History of an eating disorder.
- Severe psychiatric disorder.
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 |
|---|---|---|
| Elemental formula (mBiota Elemental, Good LFE, Santa Monica, CA)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 modulate the microbiota, suppress proinflammatory cytokines, support epithelial repair, and exclude common dietary additives that may provoke inflammation. | Dietary supplement | Habitual Diet, Reduced Sulfur Diet |
| Reduced Sulfur dietThis 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. | Behavioural | Reduced Sulfur Diet |
| Habitual DietParticipants randomized to the comparator group will continue their usual dietary intake for 10 weeks without specific dietary restrictions. | Behavioural | Habitual Diet |
Primary outcome
Composite clinical and biochemical response
Time frame: Baseline, Week 2 and week 12
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.
11 secondary outcomes
Stool Biomarkers
Time frame: Baseline, week 2 and week 12
C-Reactive Protein (CRP) concentration
Time frame: Baseline, week 2 and week 12
Complete Blood Count (CBC) parameters
Time frame: Baseline, week 2 and week 12
Serum inflammatory biomarker concentrations
Time frame: Baseline, week 2 and week 12
Breath Biomarkers
Time frame: Baseline, week 2 and week 12
Adherence to the Elemental Diet and Reduced Sulfur Diet Intervention
Time frame: Baseline, week 2 and week 12
Change in Quality of Life
Time frame: Baseline, week 2 and week 12
Change in Anxiety
Time frame: Baseline, week 2 and week 12
Change in Depression
Time frame: Baseline, week 2 and week 12
Change in Weight
Time frame: Baseline, week 2 and week 12
Change in Body Mass Index (BMI)
Time frame: Baseline, week 2 and week 12
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 11 Jun 2026.
- Individual participant dataSharing planned: Yes. All IPD used in the results of the publication will be shared
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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.
Natasha Haskey, RD, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elemental formula (mBiota Elemental, Good LFE, Santa Monica, CA), Reduced Sulfur diet and Habitual Diet in people with Ulcerative Colitis (UC), run by University of British Columbia at 1 site in Canada.
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 8 inclusion and 23 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: opening soon, as of the sponsor's last update on 11 Jun 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 Canada. 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 Natasha Haskey, PhD (250-807-9597, natasha.haskey@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite clinical and biochemical response (time frame: Baseline, Week 2 and week 12). 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 11 Jun 2026.