40 Participants NeededMy employer runs this trial

Sucralose for Crohn's Disease

Recruiting at 2 trial locations
SS
AR
Overseen ByAbigail Raffner, RD, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Case Western Reserve University
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 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).

Who Is on the Research Team?

FC

Fabio Cominelli, MD, PhD

Principal Investigator

Case Western Reserve University

AR

Abigal Raffner, PhD, RD

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 (IBD), as well as healthy people without IBD. Participants should not have other types of IBD or recent surgeries related to the condition.

Inclusion Criteria

I am able to keep a record of what I eat.
I am male or female.
I have Crohn's disease and my condition is currently in remission.
See 4 more

Exclusion Criteria

I have fewer than one natural bowel movement every three days.
I have taken antibiotics in the past 14 days.
I am able to understand and give consent for my participation.
See 15 more

What Are the Treatments Tested in This Trial?

Interventions

  • Sucralose

Trial Overview

The study tests whether taking sucralose, an artificial sweetener (2 sachets per day), changes gut bacteria in people with Crohn's Disease compared to healthy individuals. The design compares these two groups over time.

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?

Case Western Reserve University

Lead Sponsor

Trials
314
Recruited
236,000+

Crohn's and Colitis Foundation

Collaborator

Trials
44
Recruited
27,500+