40 Participants NeededMy employer runs this trial

Sucralose for Inflammatory Bowel Disease

Recruiting at 2 trial locations
AR
SS
Overseen BySargun Singh, M.B.B.S.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University Hospitals Cleveland Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Who Is on the Research Team?

FC

Fabio Cominelli, MD PhD

Principal Investigator

University Hospitals Cleveland Medical Center

AR

Abigail Raffner, RD PhD

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with Crohn's disease (a type of inflammatory bowel disease) and healthy people without IBD. Participants should not have other types of IBD or recent surgeries related to the gut.

Inclusion Criteria

Able to complete daily surveys and take oral nutrition
Able to record meal intake
I have Crohn's disease and my condition is currently in remission.
See 4 more

Exclusion Criteria

Hospitalized patients
Known drug abuse
Well-founded doubt about the patient's cooperation
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Removal of all non-nutritive sweeteners from the diet

2 weeks
1 virtual visit

Sucralose Intervention

Participants consume sucralose (2 sachets/day) to study its effect on gut microbiota

3 weeks
2 in-person visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Sucralose

Trial Overview

The study tests how taking sucralose, a common artificial sweetener, affects gut bacteria in people with Crohn's disease compared to healthy individuals. Participants will consume two sachets of sucralose daily.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Healthy ControlsExperimental Treatment1 Intervention
Group II: Crohn's participantsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials
348
Recruited
394,000+

Crohn's and Colitis Foundation

Collaborator

Trials
44
Recruited
27,500+