RECRUITING

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

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Conditions

Crohn's Disease in RemissionCrohn's diseaseQuiescent Crohn's diseaseLow sulfur dietMicrobiome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-12-12
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05849012

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Prior diagnosis of Crohn's disease based on endoscopic, radiographic, and/or histologic findings
  2. * 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
  3. * 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)
  1. * Prior total colectomy
  2. * Presence of an end ileostomy or colostomy in place
  3. * Changes in immunosuppressive medications within the past 4 weeks
  4. * Use of antibiotics or probiotics within the past 4 weeks
  5. * Active or suspected stricture/stenosis of the GI tract
  6. * Habitual vegetarian or vegan diet
  7. * Active or suspected gastrointestinal stricture or stenosis
  8. * Unable or unwilling to follow a low sulfur diet
  9. * 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
  10. * 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
  11. * 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.

Contacts and Locations

Study Contact

Allen Lee, MD, MS
CONTACT
734-936-9454
allenlee@umich.edu
Michael Santiago-Castro
CONTACT
santiamn@med.umich.edu

Principal Investigator

Allen Lee, MD, MS
PRINCIPAL_INVESTIGATOR
Assistant Professor

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-12
Study Completion Date2026-07

Study Record Updates

Study Start Date2023-12-12
Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Crohn's Disease in Remission