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Non-nutritive Sweeteners in Inflammatory Bowel Disease

NCT07769437 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-18

No results posted yet for this study

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 IBD, compared to healthy non-IBD individuals. We 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).

Conditions

  • Inflamatory Bowel Disease
  • Crohn Disease (CD)

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.

Sponsors & Collaborators

  • Crohn's and Colitis Foundation

    collaborator OTHER

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Fabio Cominelli, MD PhD · University Hospitals Cleveland Medical Center

  • Abigail Raffner, RD PhD · Case Western Reserve University

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-03
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07769437 on ClinicalTrials.gov