Investigating the Effect of the Non-nutritive Sweetener Sucralose in Inflammatory Bowel Disease
Not applicable · Testing Sucralose (non-nutritive sweetener) · 3 sites · Case Western Reserve University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Sucralose (non-nutritive sweetener) to better understand how the disease works. Condition(s) listed: Inflamatory Bowel Disease and Crohn Disease (CD).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 75
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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
Plus 1 more requirement(s). There are also 18 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 40 participants are expected to take part.
- The study has 2 groups.
- Start date: 2024-04-18.
- Main results expected around 2026-12 (estimate from the record).
- 3 study sites listed (3 marked recruiting) in United States.
Groups in this study
- Crohn's participants (listed as: experimental group)
- Healthy Controls (listed as: experimental group)
Main thing being measured
- Change in fecal microbiome (Baseline, 14 days post-baseline, and 21 days post-intervention)
In the researchers’ words
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…
Words you might see
- Remission: a period when the disease is quiet or under control.
- Stricture: a narrowing (of the bowel or of a bile duct).
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Inflamatory Bowel Disease; Crohn Disease (CD) |
| Lead sponsor | Case Western Reserve University |
| Collaborators | Crohn's and Colitis Foundation |
| Enrollment | 40 (estimated) |
| Start date | 2024-04-18 |
| Primary completion (est.) | 2026-12 |
| First posted | 2026-10-01 |
| Last updated | 2026-10-01 |
| Official title | The Effect of Non-Nutritive Food Sweeteners in Inflammatory Bowel Disease |
| ClinicalTrials.gov ID | NCT07852273 |
Interventions
- 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.
Full eligibility criteria (from the record)
Inclusion Criteria: * 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) Exclusion Criteria: * 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 * 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
Locations (3)
| Site | City | Country | Site status |
|---|---|---|---|
| UH Minoff Health Center | Chagrin Falls, Ohio | United States | Recruiting |
| University Hospitals Cleveland Medical Center | Cleveland, Ohio | United States | Recruiting |
| UH Westlake Health Center | Westlake, Ohio | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.