An interventional study of Sucralose (non-nutritive sweetener) in Inflamatory Bowel Disease and Crohn Disease (CD), sponsored by University Hospitals Cleveland Medical Center. Recruiting at 3 sites in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by University Hospitals Cleveland Medical Center · Not applicable, Interventional, and Other
Among 660 studies in Crohn Disease with a site in United States — 123 open to participants now, 164 under way, 35 of them phase 3. Crohn Disease · United States.
Among the 660 studies in Crohn Disease with a site in United States, this one is the 310th largest by planned enrollment of the 528 interventional ones, is one of 30 that started in 2025, is one of 128 with no phase, reaches primary completion later than 30 of the 162 other live ones, and was the 656th registered.
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
This study's planned enrollment of 40 is below the median of 67 across 1,260 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →123 of the 660 studies in Crohn Disease with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 354 Crohn Disease studies recruiting now, 155 (44%) set no upper age limit and 144 (41%) stop at 75 or younger; 96 take children under 18; 56 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · healthy volunteers too.
The full table on the hub →660 studies; the count open now beside each. This study's row is marked.
First in 1995; this study’s year is marked. 30 started in 2025.
Median enrollment 60 across the 528 interventional studies, 168 across the 128 observational. Of the 452 that completed or were terminated, 205 (45%) have results posted.
310 of 660 have an industry lead sponsor. The 10 most frequent:
University Hospitals Cleveland Medical Center is the lead sponsor of 295 studies on the registry; 45 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 30 (83%) have results posted.
University Hospitals Cleveland Medical Center has 7 studies filed under Crohn Disease — fewer than ten, so there is no comparison to draw.
59 of the studies in Crohn Disease with a site in United States that are under way reach primary completion within a year, 9 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06063967Phase 3AbbVieA Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease. | 2027-03 |
| NCT05347095Phase 3Janssen-Cilag Ltd.A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease | 2027-03-25 |
| NCT05660746Phase 3Children's Hospital Medical Center, CincinnatiPrecise Infliximab Exposure and Pharmacodynamic Control | 2027-03-31 |
| NCT06408935Phase 3Janssen-Cilag Ltd.Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients | 2027-06-08 |
| NCT06227910Phase 3TakedaA Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease | 2027-06-08 |
Among the 660 studies in Crohn Disease with a site in United States, from their registry updates:
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).
Participation in this study will last for a minimum of 35 days (Phase I: 14-days; baseline with removal of all NNS (eg saccharin, sucralose, steviosides, aspartame, acesulfame-k, erythritol) from the diet, Phase II: 21-days; sucralose intervention, and will involve one virtual visit (study visit 1) and two in-person study visits (study visit 2 and study visit 3).
Fecal \& urine samples will be collected before/after each phase. Blood will also be collected.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Crohn's participants will consume artificial sweetener: sucralose
Other: Sucralose (non-nutritive sweetener)
Healthy control participants will consume artificial sweetener: sucralose
Other: Sucralose (non-nutritive sweetener)
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.
Change in fecal microbiome measured by metagenome analysis
Quantify the change in the fecal microbiome using metagenome analysis
Time frame: Baseline, three weeks pre-intervention, and three weeks after intervention
Change in Fecal Myeloperoxidase activity (MPO)
Quantify the change in fecal MPO
Time frame: Baseline, three weeks pre-intervention, three weeks post-intervention
Change in Fecal Calprotectin
Quantify the change in fecal calprotectin
Time frame: Baseline, three weeks pre-intervention, three weeks post-intervention
Change in Crohn's Disease Activity Index (CDAI)
Quantify the change in Crohn's Disease Activity Index. The Crohn's Disease Activity Index (CDAI) is a validated clinical instrument used to quantify Crohn's disease activity. It evaluates 8 components over a 7-day period: number of liquid or very soft stools, severity of abdominal pain, general well-being, extraintestinal complications, use of antidiarrheal medications, presence of an abdominal mass, hematocrit levels, and body weight deviation. Each component is multiplied by a specific weighting factor and summed to calculate a total score. Total scores range from 0 to approximately 600 points, where lower scores indicate lower disease activity. A score of \<150 indicates clinical remission, while a score of \>450 indicates severe disease. A negative change from baseline indicates clinical improvement.
Time frame: Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention)
Change in C-reactive protein (CRP)
Quantify change in CRP
Time frame: Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention)
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2025 (actual). Primary completion is estimated for Dec 2026, 22 months after the start.
Of 287 non-industry interventional studies with no phase under Crohn Disease, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 67. This study's planned 22 months is below that.
Counting every sponsor, half of 299 studies reached it within 45 months; a quarter within 21 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University Hospitals Cleveland Medical Center →