Sucralose Sweetener and Gut Bacteria in People With Crohn's Disease
Tests how sucralose changes gut bacteria in adults with Crohn's disease.
Key facts
- Who runs it
- University Hospitals Cleveland Medical Center
- Where
- Chagrin Falls, Cleveland, and Westlake, United StatesSee the 3 sites
- Trial code
- Registry title
- Non-nutritive Sweeteners in Inflammatory Bowel Disease
- Status
- Recruiting
- People taking part
- 40 people, planned
- Started
- 3 Feb 2025
- Expected to end
- Dec 2026
- Type of study
- Interventional, 2 groups
- Treatments tested
- Sucralose (non-nutritive sweetener)
- Record updated
- 25 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with Crohn's disease who are in remission, and healthy adults without bowel disease. It studies how the sweetener sucralose changes gut bacteria.
- Age
- 18 to 70 years
- Sex
- All sexes can join.
- Disease stage
- Crohn's disease in remission, with a Harvey Bradshaw index below 6, treated as an outpatient. Healthy controls must not have IBD or irritable bowel syndrome (IBS).
- Earlier treatment
- No antibiotics in the last 14 days. No change in IBD medication in the last 4 weeks.
Main reasons for not taking part
- Short bowel syndrome, an ostomy, or a symptomatic narrowing of the bowel
- Being in hospital
- Pregnancy or breastfeeding
- Body mass index below 18 or 35 and above
- Bariatric surgery or phenylketonuria
The registry criteria, word for word
Show all 25 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Known drug abuse
- Change in IBD medication within past 4 weeks
- Bariatric surgery
- 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
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Where in United States
- UH Minoff Health CenterChagrin Falls, United StatesContact: Abigail Basson, RD PhDTaking people
- University Hospitals Cleveland Medical Center*Cleveland, United StatesContact: Abigail Basson, RD PhDTaking people
- UH Westlake Health CenterWestlake, United StatesContact: Abigail Basson, RD PhDTaking people
About the trial
What the trial wants to find out
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).
The 2 groups in the trial
- Crohn's participantsTreatment being tested
Crohn's participants will consume artificial sweetener: sucralose
Treatment: Sucralose (non-nutritive sweetener)
- Healthy ControlsTreatment being tested
Healthy control participants will consume artificial sweetener: sucralose
Treatment: Sucralose (non-nutritive sweetener)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Effect of Non-Nutritive Food Sweeteners in Inflammatory Bowel Disease
- Plain-language title
- Sucralose Sweetener and Gut Bacteria in People With Crohn's DiseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07769437, who can take part
- Record updated
- 25 September 2026