A Pilot Study Examining Low Sulfur Diet as Treatment for Persistent Symptoms in Quiescent Crohn's Disease

Conditions

• Crohn's Disease in Remission

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Low Sulfur Diet — OTHER
  Subjects will be placed on a low sulfur diet for 8 weeks with the support of a nutritionist. In addition, participants will be asked to complete: surveys, lactulose-mannitol test, glucose hydrogen breath test, blood samples, visceral sensation test, 24-hour urine sample for sulfate level, provide stool samples, optional colonoscopy.
• Usual Diet — OTHER
  Subjects will continue on their usual diet for 8 weeks. At the end of 8 weeks, if participants are interested, they will be offered treatment with low sulfur diet for 8 weeks with the support of a nutritionist. In addition, participants will be asked to complete: surveys, lactulose-mannitol test, glucose hydrogen breath test, blood samples, visceral sensation test, 24-hour urine sample for sulfate level, provide stool samples, optional colonoscopy.

Study Details

The goal of this study is to learn about a low sulfur diet in patients with Crohn's disease. Study participants will be randomized to receive a low sulfur diet or usual diet for 8 weeks. Participants will work with study nutritionists and receive dietary educational materials. Participants will attend 2 in-person visits as well as 6 phone visits during the study. In addition, subjects will undergo testing, including a test to measure rectal sensation, a test to look for small intestinal bacterial overgrowth, and a test to measure leaky gut.

Key Dates

Start date

Dec 12, 2023

Status verified

Jan 2026

Primary completion

Dec 30, 2026

Completion

Apr 30, 2027

Study Design

Enrollment

20 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Low Sulfur Diet
  Participants in this group will follow a low sulfur diet. This diet decreases the amount of animal products (including meat, dairy, and eggs) as well as sulfur additives in the diet. The main types of foods in the low sulfur diet include fruits, vegetables, whole grains, nuts, seeds, and soy products.
• Active Comparator: Usual Diet
  Participants in this group will follow a standard of care usual diet for 8 weeks.

Primary Outcome Measure

Dietary Protein Intake for both groups as assessed by 24 hour diet recall [ Time Frame: 8 weeks ]

Central Contacts

• Allen Lee, MD, MS
  734-936-9454
  [email protected]
• Merrick Bay
  [email protected]

Locations (1)

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