Non-nutritive Sweeteners in Inflammatory Bowel Disease

August 11, 2026 updated by: Fabio Cominelli, University Hospitals Cleveland Medical Center

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participation in this study will last for a minimum of 35 days (Phase I: 14-days; baseline with removal of all NNS (eg saccharin, sucralose, steviosides, aspartame, acesulfame-k, erythritol) from the diet, Phase II: 21-days; sucralose intervention, and will involve one virtual visit (study visit 1) and two in-person study visits (study visit 2 and study visit 3).

Fecal & urine samples will be collected before/after each phase. Blood will also be collected.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Chagrin Falls, Ohio, United States, 44122
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center
        • Sub-Investigator:
          • Jeffry Katz, MD
        • Contact:
        • Sub-Investigator:
          • Vu Nguyen, MD
      • Westlake, Ohio, United States, 44145

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Age range from: 18 to 70 years. Male or female. Documented diagnosis of Crohns disease. CD outpatients in remission; Harvey Bradshaw- index in remission (<6 score).

Capable of providing consent to participate. Able to complete daily surveys and take oral nutrition. Able to record meal intake. Healthy controls with no diagnosis of IBD or Irritable Bowel Syndrome (IBS).

Exclusion Criteria:

Short bowel syndrome. Hospitalized patients. Individuals who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, dementia patients.

Known drug abuse. Known parasitic disease of the digestive system. Symptomatic intestinal stricture/narrowing. Presence of an ostomy. Known active malignancy. Antibiotic use within last 14 days. Well-founded doubt about the patients cooperation. Existing pregnancy or lactation. History of <1 natural bowel movements per 3 consecutive days. Unable to access to technology that permits the daily completion of study related activities.

Change in IBD medication within past 4 weeks. Body mass Index <18 kg/m or ≥35 kg/m. Documented C.difficile colitis within four weeks of screening. Bariatric surgery Phenylketonuria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Crohn's participants
Crohn's participants will consume artificial sweetener: sucralose
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.
Experimental: Healthy Controls
Healthy control participants will consume artificial sweetener: sucralose
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fecal microbiome measured by metagenome analysis
Time Frame: Baseline, three weeks pre-intervention, and three weeks after intervention
Quantify the change in the fecal microbiome using metagenome analysis
Baseline, three weeks pre-intervention, and three weeks after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fecal Myeloperoxidase activity (MPO)
Time Frame: Baseline, three weeks pre-intervention, three weeks post-intervention
Quantify the change in fecal MPO
Baseline, three weeks pre-intervention, three weeks post-intervention
Change in Fecal Calprotectin
Time Frame: Baseline, three weeks pre-intervention, three weeks post-intervention
Quantify the change in fecal calprotectin
Baseline, three weeks pre-intervention, three weeks post-intervention
Change in Crohn's Disease Activity Index (CDAI)
Time Frame: Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention)
Quantify the change in Crohn's Disease Activity Index. The Crohn's Disease Activity Index (CDAI) is a validated clinical instrument used to quantify Crohn's disease activity. It evaluates 8 components over a 7-day period: number of liquid or very soft stools, severity of abdominal pain, general well-being, extraintestinal complications, use of antidiarrheal medications, presence of an abdominal mass, hematocrit levels, and body weight deviation. Each component is multiplied by a specific weighting factor and summed to calculate a total score. Total scores range from 0 to approximately 600 points, where lower scores indicate lower disease activity. A score of <150 indicates clinical remission, while a score of >450 indicates severe disease. A negative change from baseline indicates clinical improvement.
Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention)
Change in C-reactive protein (CRP)
Time Frame: Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention_
Quantify change in CRP
Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention_

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Collaborators

Crohn's and Colitis Foundation

Investigators

  • Principal Investigator: Fabio Cominelli, MD PhD, University Hospitals Cleveland Medical Center
  • Principal Investigator: Abigail Raffner, RD PhD, Case Western Reserve University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

August 11, 2026

First Submitted That Met QC Criteria

August 11, 2026

First Posted (Actual)

August 18, 2026

Study Record Updates

Last Update Posted (Actual)

August 18, 2026

Last Update Submitted That Met QC Criteria

August 11, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY20221141

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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