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Low Sulfur Diet for Persistent Symptoms in Crohn's Disease

This study is exploring whether a low sulfur diet can help people with Crohn's disease who are in remission (quiescent) but still have symptoms like abdominal pain or diarrhea. We want to see if changing your diet can affect the microbes in your gut (gut microbiome) and improve these symptoms. Participants will be randomly assigned to either follow a low sulfur diet for 8 weeks with nutritionist support, or continue their usual diet for 8 weeks. The study will measure changes in your diet and sulfate levels in your urine. To join, you need to be 18 or older, have a Crohn's disease diagnosis, and be in remission but still experiencing persistent symptoms. The study is currently recruiting about 20 participants.

Study design
This is an interventional study where participants are randomly assigned to one of two groups: a low sulfur diet or their usual diet. About 20 participants will be enrolled.
What's involved
You will have an initial phone visit, two in-person visits, and six phone visits over approximately 8 weeks. You will also complete surveys, provide blood and urine samples, and undergo several tests, including one for rectal sensation and another for gut bacteria.
Compensation
Not stated in the trial record.
Follow-up
The study assesses dietary protein intake at 8 weeks and again at approximately 16 weeks, and urinary sulfate at 8 weeks.

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NCT05849012

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

Recruiting
NAAges 18+InterventionalTreatment
University of Michigan
~20 participants
Updated 2026-01-15 on ClinicalTrials.gov
What's tested:Low Sulfur DietUsual Diet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dietary Protein Intake for both groups as assessed by 24 hour diet recall
Measured over 8 weeks
+3 more outcomes measured

Conditions

Crohn's Disease in Remission

Explore related trials

Crohn Disease

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Allen Lee, MD, MS · PRINCIPAL_INVESTIGATOR · Assistant Professor

Who to contact

Allen Lee, MD, MS
[email protected]
734-936-9454
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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)

Exclusion

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.

What this trial measures

  • Dietary Protein Intake for both groups as assessed by 24 hour diet recall8 weeks

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

  • Dietary Protein Intake as assessed by 24 hour diet recallApproximately 16 weeks

    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.

  • Change in 24 hour urinary sulfate8 weeks

    Change in 24 hour urinary sulfate level from baseline

  • Change in 24 hour urinary sulfateApproximately 16 weeks

    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