Inflamatory Bowel DiseaseNCT07852273
Investigating the Effect of the Non-nutritive Sweetener Sucralose in Inflammatory Bowel Disease
A study testing Sucralose (non-nutritive sweetener) in people with Inflamatory Bowel Disease and Crohn Disease (CD), run by Case Western Reserve University at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflamatory Bowel Disease, Crohn Disease (CD)
- What is being tested?
- Sucralose (non-nutritive sweetener)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Apr 2024to Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
UH Minoff Health Center
Chagrin Falls, Ohio, 44122
Abigail Basson, RD PhD, Abigail.Basson@uhhospitals.org
Jeffry Katz, MD
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Abigail Basson, RD PhD, 1-888-844-8447, Abigail.Basson@uhhospitals.org
Vu Nguyen, MD
- Recruiting
UH Westlake Health Center
Westlake, Ohio, 44145
Abigail Basson, RD PhD, Abigail.Basson@uhhospitals.org
Vu Nguyen, MD
About this study
Official title: The Effect of Non-Nutritive Food Sweeteners in Inflammatory Bowel Disease
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).
Read the detailed description
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.
- Conditions
- Inflamatory Bowel Disease, Crohn Disease (CD)
- Being tested
- Sucralose (non-nutritive sweetener)
- Keywords
- sweeteners, sucralose, inflammatory bowel disease, crohn's disease, IBD, CD, artificial sweeteners
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sucralose (non-nutritive sweetener)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Crohn's participants | Experimental | Crohn's participants will consume the artificial sweetener sucralose Receives: Other: Sucralose (non-nutritive sweetener) |
| Healthy Controls | Experimental | Healthy control participants will consume the artificial sweetener sucralose Receives: Other: Sucralose (non-nutritive sweetener) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fecal microbiome
Quantify the change in the fecal microbiome as measured by metagenome analysis
Measured: Baseline, 14 days post-baseline, and 21 days post-intervention
Secondary outcomes (5)
Change in Fecal Myleoperoxidase activity (MPO)
Quantify the change in fecal MPO
Measured: Baseline, 14 days post-baseline, and 21 days post-intervention
Change in Fecal Calprotectin
Quantify the change in fecal calprotectin
Measured: Baseline, 14 days post-baseline, and 21 days post-intervention
Change in Short Crohn's Disease Activity Index (sCDAI)
Quantify before/after intervention self-reported indices for Crohn's Disease patients using the sCDAI. The sCDAI, a shortened version of the Crohns Disease Activity Index, is a 4-question survey with abdominal pain, diarrhea frequency, and general well-being domains, reported over the previous 7 days. Score scale for sCDAI is: <150 define remission, 150-219 mild activity, 220-450 moderate activity, >450 severe activity.
Measured: Baseline, 14 days post-baseline, and 21 days post-intervention
Change in Crohns Disease Activity Index (CDAI)
Quantify before/after intervention indices for Crohn's Disease patients using the CDAI. CDAI score is: <150 define remission, 150-219 mild activity, 220-450 moderate activity, >450 severe activity.
Measured: Baseline, 14 days post-baseline, and 21 days post-intervention
Change in C-reactive protein (CRP)
Quantify change in CRP before/after intervention
Measured: 14 days post-baseline and 21 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start18 Apr 2024
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflamatory Bowel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two groups; Crohn's and Healthy participants who undergo the same intervention
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- Crohn's and Colitis Foundation
- Responsible party
- Sponsor
- Investigators
- Fabio Cominelli, MD, PhD, Principal investigator, Case Western Reserve UniversityAbigal Raffner, PhD, RD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852273
- Sponsor's protocol ID
- 20221141
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No