Using Breath Tests to Study Gut Sulfur Changes During Dietary Therapy

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Habitual Diet: Participants randomized to the comparator group will continue their usual dietary intake for 10 weeks without specific dietary restrictions.

Study 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. 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

Primary outcome measure(s)

• Composite clinical and biochemical response — 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.

Trial sites (1)

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