Inflamatory Bowel DiseaseNCT07769437
Non-nutritive Sweeteners in Inflammatory Bowel Disease
A study testing Sucralose (non-nutritive sweetener) in people with Inflamatory Bowel Disease and Crohn Disease (CD), run by University Hospitals Cleveland Medical Center 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 IBD, compared to healthy non-IBD individuals. Read more about this study
- Who is it for?
- Ages 18 to 70 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
- 3 Feb 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 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.
Show all 18Show fewer
- 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.
- 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
- 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, 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 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).
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 artificial sweetener: sucralose Receives: Other: Sucralose (non-nutritive sweetener) |
| Healthy Controls | Experimental | Healthy control participants will consume 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 measured by metagenome analysis
Quantify the change in the fecal microbiome using metagenome analysis
Measured: Baseline, three weeks pre-intervention, and three weeks after intervention
Secondary outcomes (4)
Change in Fecal Myeloperoxidase activity (MPO)
Quantify the change in fecal MPO
Measured: Baseline, three weeks pre-intervention, three weeks post-intervention
Change in Fecal Calprotectin
Quantify the change in fecal calprotectin
Measured: 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.
Measured: Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention)
Change in C-reactive protein (CRP)
Quantify change in CRP
Measured: Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start3 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (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
- Other
- 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
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Crohn's and Colitis Foundation
- Responsible party
- Principal investigator, Fabio Cominelli, University Hospitals Cleveland Medical Center
- Investigators
- Fabio Cominelli, MD PhD, Principal investigator, University Hospitals Cleveland Medical CenterAbigail Raffner, RD PhD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769437
- Sponsor's protocol ID
- STUDY20221141
- Status last verified
- Sep 2026
- First submitted
- 11 Aug 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Non-Nutritive Food Sweeteners in Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT07769437
- Acronym / sponsor ID
- STUDY20221141
- Conditions
- Inflamatory Bowel Disease, Crohn Disease (CD)
- Keywords
- sweeteners, sucralose, inflammatory bowel disease, crohn's disease, IBD, CD, artificial sweeteners
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Crohn's and Colitis Foundation
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups; Crohn's and Healthy participants who undergo the same intervention
| Arm | Type | Receives |
|---|---|---|
| Crohn's participants | Experimental | Other: Sucralose (non-nutritive sweetener)Crohn's participants will consume artificial sweetener: sucralose |
| Healthy Controls | Experimental | Other: Sucralose (non-nutritive sweetener)Healthy control participants will consume artificial sweetener: sucralose |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Crohn's participants, Healthy Controls |
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
4 secondary outcomes
Change in Fecal Myeloperoxidase activity (MPO)
Time frame: Baseline, three weeks pre-intervention, three weeks post-intervention
Change in Fecal Calprotectin
Time frame: Baseline, three weeks pre-intervention, three weeks post-intervention
Change in Crohn's Disease Activity Index (CDAI)
Time frame: Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention)
Change in C-reactive protein (CRP)
Time frame: Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fabio Cominelli, MD PhD principal investigator
University Hospitals Cleveland Medical Center
Abigail Raffner, RD PhD principal investigator
Case Western Reserve University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sucralose (non-nutritive sweetener) in people with Inflamatory Bowel Disease and Crohn Disease (CD), run by University Hospitals Cleveland Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abigail Raffner, RD PhD (216-327-6003, Abigail.Raffner@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fecal microbiome measured by metagenome analysis (time frame: Baseline, three weeks pre-intervention, and three weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.