NCT07769437Recruiting
Non-nutritive Sweeteners in Inflammatory Bowel Disease
The Effect of Non-Nutritive Food Sweeteners in Inflammatory Bowel Disease
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 11 Aug 2026
- Start date
- 3 Feb 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Diseases
- Crohn's disease
- NCT number
- NCT07769437
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 3 Feb 2025 to the primary completion date, Dec 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known drug abuse.
- Change in IBD medication within past 4 weeks.
- Bariatric surgery
Other illness
- Short bowel syndrome.
- Individuals who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, dementia patients.
- Known parasitic disease of the digestive system.
- Known active malignancy.
- History of \<1 natural bowel movements per 3 consecutive days.
Other
- Hospitalized patients.
- Symptomatic intestinal stricture/narrowing.
- Presence of an ostomy.
- Antibiotic use within last 14 days.
- Well-founded doubt about the patients cooperation.
- Existing pregnancy or lactation.
- Unable to access to technology that permits the daily completion of study related activities.
- Body mass Index \<18 kg/m or ≥35 kg/m.
- Documented C.difficile colitis within four weeks of screening.
- Phenylketonuria
Who the study is looking for
- 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).
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UH Minoff Health Center Coordinator of this site? Confirm its status | Chagrin Falls | United States | Recruiting |
| University Hospitals Cleveland Medical Center* Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| UH Westlake Health Center Coordinator of this site? Confirm its status | Westlake | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.