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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
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Tolerability of Low Sulfur Diet based on the Visual Analog Scale (VAS)
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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Who is running the clinical trial?
University of MichiganLead Sponsor
1,798 Previous Clinical Trials
6,378,118 Total Patients Enrolled
Allen Lee, MDPrincipal InvestigatorAssistant Professor
3 Previous Clinical Trials
146 Total Patients Enrolled
Allen Lee, MD, MSPrincipal InvestigatorAssistant Professor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had my entire colon removed.I have an ileostomy or colostomy.I haven't changed my immunosuppressive medications in the last 4 weeks.I have or might have a narrowed area in my digestive tract.I have been diagnosed with Crohn's disease through tests like endoscopy.I have ongoing stomach pain or diarrhea with a score of 55 or more on the NIH PROMIS-GI scale.I have not taken antibiotics or probiotics in the last 4 weeks.I have or might have a narrowing in my digestive tract.My Crohn's disease is inactive, confirmed by tests.I am not pregnant or breastfeeding and agree to use contraception during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Low Sulfur Diet
- Group 2: Usual Diet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment into this trial still available for participants?
"The clinical research listed on clinicialtrials.gov is no longer recruiting, as the most recent revision was made on May 4th 2023. Despite this, 260 other studies are actively seeking participants at present."
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