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Non-nutritive Sweeteners in Inflammatory Bowel Disease

Sponsor: University Hospitals Cleveland Medical Center • ClinicalTrials.gov ID: NCT07769437

Registry updated: 2026-09-25

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Description

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).

Interventions

Sucralose (non-nutritive sweetener) (Other)
Participants will consume 2 sachets/day during the exposure period resulting in the following daily dose: sucralose 2.5mg/kg. This dose is below the acceptable daily intakes (ADI) of 5mg/kg.

Eligibility criteria

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

Conditions

Inflamatory Bowel Disease Crohn Disease (CD)

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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