Crohn Disease (CD) · Inflamatory Bowel Disease
Sucralose and Gut Microbiota in Adults With Crohn’s Disease and Healthy Controls
Researchers are studying changes in gut microbiota after daily sucralose consumption in adults with Crohn’s disease in remission and healthy adults without inflammatory bowel disease or irritable bowel syndrome.
Registry title: Non-nutritive Sweeteners in Inflammatory Bowel Disease
3 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years–70 Years
- Treatment
- Sucralose (non-nutritive sweetener)
- Design
- Non Randomized
- Central study contact
- Abigail Raffner, RD PhD216-327-6003Abigail.Raffner@uhhospitals.org
- Sponsor
- University Hospitals Cleveland Medical Center
Research question
How does a 21-day period of daily sucralose consumption change the fecal microbiome in people with Crohn’s disease compared with healthy participants receiving the same intervention?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 70.
- One group consists of outpatients with a documented Crohn’s disease diagnosis who are in remission, with a Harvey-Bradshaw Index below 6.
- A separate healthy-control group consists of people without inflammatory bowel disease or irritable bowel syndrome.
- Participants must be able to complete daily surveys, consume nutrition by mouth, and record their meal intake.
- The listed recruiting locations are in Chagrin Falls, Cleveland, and Westlake, Ohio.
Participation overview
What participation may involve
Participation lasts at least 35 days: 14 days without listed non-nutritive sweeteners, followed by 21 days of daily sucralose. The study includes one virtual visit, two in-person visits, daily study activities, and collection of fecal, urine, and blood samples. What participation may involve: - During the 14-day baseline phase, participants remove all listed non-nutritive sweeteners from their diet. - During the 21-day intervention phase, participants consume two sucralose sachets per day, providing 2.5 milligrams per kilogram of body weight daily. - Participants provide fecal and urine samples before and after each phase, and blood is also collected. - Participants must be able to complete daily surveys and record meal intake. The registry states that participation lasts a minimum of 35 days: a 14-day baseline phase followed by a 21-day sucralose phase. The registry describes three study visits: one virtual visit and two in-person visits.
Study interventions
What participants may receive or do
- Sucralose (non-nutritive sweetener): Participants in both groups consume two sachets per day during the exposure period, providing a daily sucralose dose of 2.5 milligrams per kilogram of body weight.
Study design
How the comparison works
This is an interventional, parallel-group study with a Crohn’s disease group and a healthy-control group. Both groups undergo the same sucralose intervention. The study is non-randomized; participants are grouped according to whether they have Crohn’s disease or are healthy controls. The study uses no masking, so the registry does not describe participants or researchers as blinded to the intervention. The healthy-control group receives the same sucralose intervention as the Crohn’s disease group, allowing researchers to compare changes between these populations. No placebo or sham intervention is listed; both study groups receive sucralose.
Reported activities
Procedures and tests
- Fecal samples are collected before and after each study phase and analyzed for changes in the microbiome using metagenome analysis.
- Fecal samples are assessed for myeloperoxidase activity and calprotectin.
- Urine samples are collected before and after each study phase.
- Blood is collected during the study.
- C-reactive protein is measured to assess change during the study.
- Crohn’s disease activity is assessed with the Crohn’s Disease Activity Index, which includes symptoms, medication use, abdominal findings, hematocrit, and body weight.
- Participants complete daily surveys and record their meal intake.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be 18 through 70 years old.
- Participants entering the Crohn’s disease group must have a documented Crohn’s disease diagnosis.
- Crohn’s disease participants must be outpatients in remission, with a Harvey-Bradshaw Index score below 6.
- Healthy-control participants must have no diagnosis of inflammatory bowel disease or irritable bowel syndrome.
- Participants must be able to provide consent.
- Participants must be able to complete daily surveys, consume nutrition by mouth, and record meal intake.
Possible reasons someone may not be able to join
- People with short bowel syndrome, an ostomy, or a symptomatic intestinal stricture or narrowing are excluded.
- Hospitalized patients are excluded.
- People who used antibiotics within the previous 14 days are excluded.
- People whose inflammatory bowel disease medication changed within the previous four weeks are excluded.
- People with documented Clostridioides difficile colitis within four weeks of screening are excluded.
- People with a known parasitic disease of the digestive system are excluded.
- People who are pregnant or lactating are excluded.
- People with a body mass index below 18 or at least 35 are excluded.
- People with known active malignancy are excluded.
- People with a history of fewer than one natural bowel movement over three consecutive days are excluded.
- People unable to access technology needed for daily study activities are excluded.
- People with prior bariatric surgery or phenylketonuria are excluded.
Important unknowns
What the record does not make clear
- The registry identifies one virtual and two in-person visits but does not provide the timing or expected length of each visit.
- The registry excludes people with an inflammatory bowel disease medication change in the previous four weeks but does not explain which ongoing treatments may continue during the study.
- The registry gives timing restrictions for recent antibiotics and inflammatory bowel disease medication changes but does not provide a complete medication washout policy.
- The registry does not describe what treatment or study procedures apply if Crohn’s disease symptoms worsen.
- The registry does not state which study-related costs are covered or whether insurance may be billed.
- The registry does not state whether participants receive compensation.
- The registry does not state whether transportation, parking, mileage, or other travel expenses are supported.
- The registry does not describe whether participants receive individual test findings or an overall study-results summary after participation.
Before contacting the site
Questions for the study team
- When does each study visit occur, how long does it take, and which Ohio location would I attend?
- Exactly which foods, drinks, medicines, and supplements containing non-nutritive sweeteners must be avoided during the baseline phase?
- Which Crohn’s disease medicines and other treatments may continue during the study, and are any changes required?
- What should a participant do if symptoms worsen or a medication change becomes necessary during the study?
- What daily surveys and meal records are required, and approximately how much time do they take?
- How often and where are blood, fecal, and urine samples collected, and what preparation is required?
- Are there participant costs, compensation, or travel and parking support?
Before changing care
Questions for your gastroenterologist
- Is my Crohn’s disease stable enough to discuss a study that requires remission and a Harvey-Bradshaw Index below 6?
- Could the required dietary removal of non-nutritive sweeteners or daily sucralose intake affect my symptoms, nutrition plan, or other conditions?
- Which of my current medicines, supplements, or nutrition products should the research team review before I contact the study?
- What approved treatment alternatives or monitoring options should I consider if my Crohn’s disease symptoms change while I am exploring this study?
- How should my gastroenterology team and the research team coordinate disease monitoring, laboratory results, and any needed treatment changes?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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. We 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.
Study design and administration
- Organization
- University Hospitals Cleveland Medical Center
- Organization class
- Other
- Organization study ID
- STUDY20221141
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Non Randomized
- Intervention model
- Parallel
- Primary purpose
- Other
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
Crohn's participants
Crohn's participants will consume artificial sweetener: sucralose
Interventions: Other: Sucralose (non-nutritive sweetener)
Experimental
Healthy Controls
Healthy control participants will consume artificial sweetener: sucralose
Interventions: Other: Sucralose (non-nutritive sweetener)
Interventions
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.
Eligibility
18 Years–70 Years
All
Accepted
Inclusion criteria (2)
- 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).Registry-derived · unreviewed
- 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).Registry-derived · unreviewed
Exclusion criteria (3)
- Short bowel syndrome. Hospitalized patients. Individuals who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, dementia patients.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- 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 PhenylketonuriaRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Change in fecal microbiome measured by metagenome analysis
Time frame: Baseline, three weeks pre-intervention, and three weeks after intervention
Quantify the change in the fecal microbiome using metagenome analysis
Secondary outcome
Change in Fecal Myeloperoxidase activity (MPO)
Time frame: Baseline, three weeks pre-intervention, three weeks post-intervention
Quantify the change in fecal MPO
Secondary outcome
Change in Fecal Calprotectin
Time frame: Baseline, three weeks pre-intervention, three weeks post-intervention
Quantify the change in fecal calprotectin
Secondary outcome
Change in Crohn's Disease Activity Index (CDAI)
Time frame: Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention)
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.
Secondary outcome
Change in C-reactive protein (CRP)
Time frame: Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention_
Quantify change in CRP
Recruiting locations in the United States
UH Minoff Health Center
RecruitingChagrin Falls, Ohio, 44122, United States
Abigail Basson, RD PhDAbigail.Basson@uhhospitals.org
Jeffry Katz, MD
University Hospitals Cleveland Medical Center
RecruitingCleveland, Ohio, 44106, United States
Abigail Basson, RD PhDAbigail.Basson@uhhospitals.org
Vu Nguyen, MD
Jeffry Katz, MD
UH Westlake Health Center
RecruitingWestlake, Ohio, 44145, United States
Abigail Basson, RD PhDAbigail.Basson@uhhospitals.org
Vu Nguyen, MD
Central study contacts
Registry dates
- First posted
- Aug 18, 2026
- Primary completion
- Dec 2026
- Overall completion
- Dec 2026
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.