Non-nutritive Sweeteners in Inflammatory Bowel Disease
The Effect of Non-Nutritive Food Sweeteners in Inflammatory Bowel Disease
- Inflamatory Bowel Disease
- Crohn Disease (CD)
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- University Hospitals Cleveland Medical Center
- Enrolment target
- 40
- Started
- 3 February 2025
- Main results due
- December 2026
- Study sites
- 3
- Registry updated
- 25 September 2026
Can you take part?
- Ages 18 years to 70 years.
- Open to any sex.
- Healthy volunteers can take part.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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
What this study is about
In the sponsor’s own words, from the registry.
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).
Study sites(3)
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
Showing 3 of 3 sites. 3 of the 3 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07769437. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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