Impact of sucralose on gut health in Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants with Crohn's disease in remission and healthy controls will undergo a 35-day study. The first 14 days remove all non-nutritive sweeteners from the diet, followed by 21 days of sucralose intervention at a dose of 2.5 mg/kg per day. The study collects fecal and urine samples before and after each phase, and includes one virtual visit and two in-person visits for clinical assessments and blood draws. The goal is to see how sucralose may alter the gut microbiota and related markers in Crohn's disease. Results could inform whether sucralose exposure affects gut health differently in IBD patients versus healthy individuals.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age range from: 18 to 70 years.
* Male or female.
* Documented diagnosis of Crohns disease. CD outpatients in remission; Harvey Bradshaw- index in remission (\<6 score).
* Capable of providing consent to participate.
* Able to complete daily surveys and take oral nutrition.
* Able to record meal intake.
* Healthy controls with no diagnosis of IBD or Irritable Bowel Syndrome (IBS).

Exclusion Criteria:

* Short bowel syndrome.
* Hospitalized patients.
* Individuals who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, dementia patients.
* Known drug abuse.
* Known parasitic disease of the digestive system.
* Symptomatic intestinal stricture/narrowing.
* Presence of an ostomy.
* Known active malignancy.
* Antibiotic use within last 14 days.
* Well-founded doubt about the patients cooperation.
* Existing pregnancy or lactation.
* History of \<1 natural bowel movements per 3 consecutive days.
* Unable to access to technology that permits the daily completion of study related activities.
* Change in IBD medication within past 4 weeks.
* Body mass Index \<18 kg/m or ≥35 kg/m.
* Documented C.difficile colitis within four weeks of screening.
* Bariatric surgery
* Phenylketonuria

Where it's running

• UH Minoff Health Center
  Chagrin Falls, Ohio, United States Recruiting
• University Hospitals Cleveland Medical Center
  Cleveland, Ohio, United States Recruiting
• UH Westlake Health Center
  Westlake, Ohio, United States Recruiting

Study contacts

• Principal investigator: Fabio Cominelli, MD PhD — University Hospitals Cleveland Medical Center
• Study coordinator: Abigail Raffner, RD PhD
• Email: Abigail.Raffner@uhhospitals.org
• Phone: 216-327-6003

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Familial IBD Early Risk

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.