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Investigating the Effect of the Non-nutritive Sweetener Sucralose in Inflammatory Bowel Disease
The Effect of Non-Nutritive Food Sweeteners in Inflammatory Bowel Disease
Who can join
Ages 18 to 75 · All sexes · Healthy volunteers welcome
Full eligibility criteria
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
About the study
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).
What is being tested
- Sucralose (non-nutritive sweetener) (other)
Sponsor: Case Western Reserve University · Participants: 40 · Started: Apr 18, 2024
Contact the study team
- Sargun Singh, M.B.B.S. · Phone: 216-333-6085
- Abigail Raffner, RD, PhD · Phone: 216-327-6003
Official record on ClinicalTrials.gov — NCT07852273
Locations in the U.S.
| Ohio | UH Minoff Health Center, Chagrin Falls University Hospitals Cleveland Medical Center, Cleveland UH Westlake Health Center, Westlake |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.