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Investigating the Effect of the Non-nutritive Sweetener Sucralose in Inflammatory Bowel Disease

RecruitingNAAges 18 Years - 75 YearsAllCase Western Reserve University
NCT07852273 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study will focus on the commonly used non-nutritive sweetener (NNS) sucralose (2 sachets/day resulting in daily dose: sucralose 2.5mg/kg) and its role in changing the gut microbiota in humans with Inflammatory Bowel Disease (IBD), compared to healthy non-IBD individuals. We will focus on studying IBD patients affected with Crohn's Disease (CD) as a proof of principle that could be tested later in other IBD subtypes (ulcerative colitis or others specific surgical conditions).

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age range from 18 to 75 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 Irritable Bowel Disease 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 patient's cooperation. * Existing pregnancy or lactation * History of \<1 natural bowel movements per 3 consecutive days * Unable to access technology that permits the daily completion of study related activities * Change in IBD medication within past 4 weeks * Body mass Index \<16 kg/m or ≥40 kg/m * Documented C.difficile colitis within four weeks of screening * Bariatric surgery * Phenylketonuria
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What it tests

  • Sucralose (non-nutritive sweetener)
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Where

3 sites
UH Minoff Health Center
Chagrin Falls, United States
University Hospitals Cleveland Medical Center
Cleveland, United States
UH Westlake Health Center
Westlake, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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