Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Using Breath Tests to Study Gut Sulfur Changes During Dietary Therapy (Sulfur-UC)

5 czerwca 2026 zaktualizowane przez: Natasha Haskey, University of British Columbia

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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

45

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Kanada
    • British Columbia
      • Kelowna, British Columbia, Kanada, V1V 1V7
        • University of British Columbia-Okanagan
        • Kontakt:
        • Główny śledczy:
          • Natasha Haskey, RD, PhD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Reduced Sulfur Diet
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.
Suplement diety: 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.
Behawioralne: Reduced Sulfur diet
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.
Aktywny komparator: Habitual Diet
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.
Suplement diety: 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.
Behawioralne: Habitual Diet
Participants randomized to the comparator group will continue their usual dietary intake for 10 weeks without specific dietary restrictions.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Composite clinical and biochemical response
Ramy czasowe: 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.
Baseline, Week 2 and week 12

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Stool Biomarkers
Ramy czasowe: Baseline, week 2 and week 12
fecal calprotectin, shotgun metagenomics (microbiome composition, sulfur metabolizing bacteria), and targeted metabolomics (e.g., hydrogen sulfide, thiosulfate)
Baseline, week 2 and week 12
C-Reactive Protein (CRP) concentration
Ramy czasowe: Baseline, week 2 and week 12
Serum CRP concentration will be measured to assess systemic inflammation.
Baseline, week 2 and week 12
Complete Blood Count (CBC) parameters
Ramy czasowe: Baseline, week 2 and week 12
CBC parameters, including hemoglobin, white blood cell count, platelet count, and differential counts, will be measured.
Baseline, week 2 and week 12
Serum inflammatory biomarker concentrations
Ramy czasowe: Baseline, week 2 and week 12
Serum concentrations of IL-6, TNF-α, MCP-1, and LBP will be measured individually and reported separately.
Baseline, week 2 and week 12
Breath Biomarkers
Ramy czasowe: Baseline, week 2 and week 12
Volatile Organic Compounds (VOCs) and exhaled breath condensate (EBC) to assess sulfur-containing metabolites and host-microbiota interactions
Baseline, week 2 and week 12
Adherence to the Elemental Diet and Reduced Sulfur Diet Intervention
Ramy czasowe: Baseline, week 2 and week 12

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:

  1. intolerance, indicated by discontinuation of dietary therapy due to the patient's refusal to continue; or
  2. low adherence scores (score of 0-1) reported on the modified Medication Adherence Report Scale; and
  3. 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.
Baseline, week 2 and week 12
Change in Quality of Life
Ramy czasowe: Baseline, week 2 and week 12
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.
Baseline, week 2 and week 12
Change in Anxiety
Ramy czasowe: Baseline, week 2 and week 12
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..
Baseline, week 2 and week 12
Change in Depression
Ramy czasowe: Baseline, week 2 and week 12
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.
Baseline, week 2 and week 12
Change in Weight
Ramy czasowe: Baseline, week 2 and week 12
Body weight will be measured in kilograms (kg)
Baseline, week 2 and week 12
Change in Body Mass Index (BMI)
Ramy czasowe: Baseline, week 2 and week 12
BMI will be calculated as weight (kg) divided by height squared (m²).
Baseline, week 2 and week 12

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of British Columbia

Współpracownicy

University of Calgary

Śledczy

  • Główny śledczy: Natasha Haskey, RD, PhD, University of British Columbia

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 marca 2029

Ukończenie studiów (Szacowany)

31 grudnia 2029

Daty rejestracji na studia

Pierwszy przesłany

29 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

5 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

11 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

11 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

5 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • H26-00017
  • POP25-11968 (Inny numer grantu/finansowania: Weston Family Foundation)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

All IPD used in the results of the publication will be shared

Kryteria dostępu do udostępniania IPD

A proposal for planned analyses must be submitted to the PI's of this research.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF
  • ANALITYCZNY_KOD
  • CSR

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Wrzodziejące zapalenie jelita grubego (UC)

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Bulgaria

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

Subskrybuj