Crohn'sRecruiting
A Pilot Study Examining Low Sulfur Diet as Treatment for Persistent Symptoms in Quiescent Crohn's Disease
Not applicable · Testing Low Sulfur Diet and Usual Diet · 1 site · University of Michigan
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Low Sulfur Diet and Usual Diet as a possible treatment. Condition(s) listed: Crohn's Disease in Remission.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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…
There are also 11 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 20 participants are expected to take part.
- Start date: 2023-12-12.
- Main results expected around 2026-12-30 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- Dietary Protein Intake for both groups as assessed by 24 hour diet recall (8 weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn's Disease in Remission |
| Lead sponsor | University of Michigan |
| Enrollment | 20 (estimated) |
| Start date | 2023-12-12 |
| Primary completion (est.) | 2026-12-30 |
| First posted | 2023-05-08 |
| Last updated | 2026-01-15 |
| Official title | A Pilot Study Examining Low Sulfur Diet as Treatment for Persistent Symptoms in Quiescent Crohn's Disease |
| ClinicalTrials.gov ID | NCT05849012 |
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. - 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 sulfat…
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan | Ann Arbor, Michigan | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.