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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 6 visits
  • Time periods mentioned: 8 weeks
  • Procedures mentioned: Phone or video check-ins, Urine samples

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Study participants will be randomized to receive a low sulfur diet or usual diet for 8 weeks."
  • "Participants will attend 2 in-person visits as well as 6 phone visits during the study."
  • "Participants will have an initial phone visit to determine eligibility to participate in the study and to review potential participants normal diet with a study nutritionist."
  • "Participants will be randomized to receive a low sulfur diet or usual diet for 8 weeks."
  • "During this visit, participants will undergo testing, including a rectal barostat test to evaluate rectal sensation, glucose hydrogen breath test to assess for small intestinal bacterial overgrowth, lactulose-mannitol test to evaluate intestinal permeability, and a 24-hour urine sample to measure urine sulfate levels."
  • "Participants will then have phone visits every 2 weeks (week 2, week, 4, and week 6)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a low sulfur diet helps people with Crohn’s disease who still have belly pain or diarrhea even when their disease is not active. Participants are assigned by chance to follow a low sulfur diet or their usual diet for 8 weeks, with help from study nutritionists. The study includes 2 in-person visits, 6 phone visits, and gut tests.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have Crohn’s disease confirmed by a scope exam, imaging, or tissue tests.
  • Have Crohn’s disease that is not active: a stool inflammation test below 150 mcg/g within 30 days of joining, and/or no inflammation on a colonoscopy within 90 days of joining.
  • Still have belly pain and/or diarrhea, with a score of at least 55 on the study’s symptom survey.

Who can't join

  • Have had the whole colon removed, or have an end ileostomy or colostomy—an opening in the belly for stool to leave the body.
  • Changed medicines that lower immune system activity in the past 4 weeks, or used antibiotics or probiotics during that time.
  • Have, or may have, a narrowed area in the digestive tract.
  • Usually eat a vegetarian or vegan diet, or cannot or will not follow a low sulfur diet.
  • Are underweight, with a body mass index (BMI) below 18.5, or lost more than 7.5% of body weight without trying in the past 3 months.
  • Are pregnant, or cannot or will not follow the birth control rules from the study’s start through the last gut leak test. These rules also apply to sexually active men and/or their female partners who could become pregnant.
  • Are breastfeeding. The listing also says breastfeeding participants must stop nursing during and for at least 12 hours after the gut leak test drink, and pump and throw away milk during that time.
  • Will not agree to avoid donating sperm, eggs, or breast milk from the study’s start through the last gut leak test.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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.

Study sites (1)

MI