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

NCT05849012 | Recruiting

• 1 other identifier: HUM00218796
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Crohn's Disease in Remission

Keywords

Crohn's disease; Quiescent Crohn's disease; Low sulfur diet; Microbiome

Outcome Measures

Primary Outcomes (4)

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

  Dietary protein intake (animal-based) as assessed by 24 hour diet recall

  8 weeks

• Dietary Protein Intake as assessed by 24 hour diet recall

  Dietary protein intake (animal-based) as assessed by 24 hour diet recall. This is for the group that voluntarily goes on the low sulfur diet after standard of care arm is completed.

  Approximately 16 weeks

• Change in 24 hour urinary sulfate

  Change in 24 hour urinary sulfate level from baseline

  8 weeks

• Change in 24 hour urinary sulfate

  Change in 24 hour urinary sulfate level from baseline. This is for the group that voluntarily goes on the low sulfur diet after standard of care arm is completed

  Approximately 16 weeks

Secondary Outcomes (4)

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

  Week 4

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

  Approximately week 12

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

  Week 8

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

  Approximately 16 weeks

Study Arms (2)

Low Sulfur Diet

EXPERIMENTAL

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.

Other: Low Sulfur Diet

Usual Diet

ACTIVE COMPARATOR

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

Other: Usual Diet

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.

Low Sulfur Diet

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.

Usual Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prior diagnosis of Crohn's disease based on endoscopic, radiographic, and/or histologic findings
• Quiescent Crohn's disease as defined by fecal calprotectin level less than 150 micrograms/gram (mcg/g) stool and/or absence of inflammation on colonoscopy within 30 and 90 days, respectively, of enrollment
• Persistent symptoms will be defined by abdominal pain and/or diarrhea T-scores greater than or equal to 55 by the National Institutes of Health (NIH) Patient-Reported outcomes measurement information system Gastrointestinal scale (PROMIS-GI)

You may not qualify if:

• Prior total colectomy
• Presence of an end ileostomy or colostomy in place
• Changes in immunosuppressive medications within the past 4 weeks
• Use of antibiotics or probiotics within the past 4 weeks
• Active or suspected stricture/stenosis of the GI tract
• Habitual vegetarian or vegan diet
• Active or suspected gastrointestinal stricture or stenosis
• Unable or unwilling to follow a low sulfur diet
• Patients who are underweight as defined by BMI \< 18.5 kg/m2 or have significant unintentional weight loss as defined by \>7.5% body weight in the past 3 months
• Currently pregnant, breastfeeding, and/or unwillingness/inability to use contraception start of the study until the last 13C-mannitol:lactulose test is complete. Sexually active male participants and/or their female partners of reproductive potential must agree to use effective contraception from the start of the study and until the last 13C-mannitol:lactulose test is complete. Women who are breastfeeding must stop breastfeeding during and for at least 12 hours after consuming the 13C-mannitol:lactulose test. Breastfeeding women must pump and dispose of the breastmilk during this time period
• Subjects must agree to not donate sperm or ova (eggs) or breast milk from the start of the study until the last 13C-mannitol:lactulose test is complete.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Allen Lee, MD, MS

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allen Lee, MD, MS

CONTACT

734-936-9454; allenlee@umich.edu

Merrick Bay

CONTACT

merricb@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 20 subjects will be randomized to receive either a low sulfur diet or usual diet.

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 8, 2023
• Study Start: December 12, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)