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Non-nutritive Sweeteners in Inflammatory Bowel Disease

RecruitingNAAges 18 Years - 70 YearsAllUniversity Hospitals Cleveland Medical Center
NCT07769437 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 IBD, compared to healthy non-IBD individuals. The investigators will focus on studying IBD patients affected with CD as a proof of principle that could be tested later in other IBD subtype (ulcerative colitis or others specific surgical conditions).

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📋 Eligibility rules (as published)
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
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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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