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

Part of paid clinical trials in Chagrin Falls, Ohio.

Sponsor
Case Western Reserve University
Study ID
NCT07852273
Status
Recruiting
Apply to this trial

Conditions

  • Crohn Disease (CD)
  • Inflamatory Bowel Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

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.

Study Details

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).

Key Dates

First listed
Oct 1, 2026
Start date
Apr 18, 2024
Status verified
Sep 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Crohn's participants
    Crohn's participants will consume the artificial sweetener sucralose
  • Experimental: Healthy Controls
    Healthy control participants will consume the artificial sweetener sucralose

Primary Outcome Measure

Change in fecal microbiome [ Time Frame: Baseline, 14 days post-baseline, and 21 days post-intervention ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
UH Minoff Health CenterChagrin FallsOhio44122
Abigail Basson, RD PhD
[email protected]
Jeffry Katz, MD (SUB_INVESTIGATOR)
University Hospitals Cleveland Medical CenterClevelandOhio44106
Abigail Basson, RD PhD
[email protected]
1-888-844-8447
Vu Nguyen, MD (SUB_INVESTIGATOR)
Jeffry Katz, MD (SUB_INVESTIGATOR)
UH Westlake Health CenterWestlakeOhio44145
Abigail Basson, RD PhD
[email protected]
Vu Nguyen, MD (SUB_INVESTIGATOR)

Find similar trials in Chagrin Falls, OH

By research site
UH Minoff Health Center· Chagrin Falls, OHUniversity Hospitals Cleveland Medical Center· Cleveland, OHUH Westlake Health Center· Westlake, OH

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