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RECRUITING
NCT07852273
NA

Investigating the Effect of the Non-nutritive Sweetener Sucralose in Inflammatory Bowel Disease

Sponsor: Case Western Reserve University

View on ClinicalTrials.gov

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 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).

Official title: The Effect of Non-Nutritive Food Sweeteners in Inflammatory Bowel Disease

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-04-18

Completion Date

2027-06

Last Updated

2026-10-01

Healthy Volunteers

Yes

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.

Locations (3)

UH Minoff Health Center

Chagrin Falls, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

UH Westlake Health Center

Westlake, Ohio, United States