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Low Sulfur Diet for Crohn's Disease

N/A

Recruiting

Led By Allen Lee, MD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 16 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how a low sulfur diet affects Crohn's patients. Participants receive dietary help and attend in-person and phone visits, and undergo tests.

Who is the study for?

This trial is for individuals with Crohn's disease who are not currently experiencing inflammation but still have symptoms like abdominal pain and diarrhea. They must have a prior diagnosis confirmed by tests, and low levels of fecal calprotectin or no inflammation seen in recent colonoscopy.

What is being tested?

The study compares the effects of an 8-week low sulfur diet to a usual diet on patients with Crohn's disease. Participants will receive dietary guidance from nutritionists and undergo various tests to assess gut health, including rectal sensation, bacterial overgrowth, and intestinal permeability.

What are the potential side effects?

Potential side effects may include changes in bowel habits or discomfort due to dietary adjustments. However, specific side effects related to the low sulfur diet are not detailed in this summary.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in 24 hour urinary sulfate

Dietary Protein Intake as assessed by 24 hour diet recall

Dietary Protein Intake for both groups as assessed by 24 hour diet recall

Secondary study objectives

Tolerability of Low Sulfur Diet based on the Visual Analog Scale (VAS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Low Sulfur DietExperimental Treatment1 Intervention

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.

Group II: Usual DietActive Control1 Intervention

Participants in this group will follow a standard of care usual diet for 8 weeks.

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