Recruiting

Impact of Sucralose on Gut Microbiota in Crohn's Disease Patients

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This study aims to quantify the change in the fecal microbiome of Crohn's Disease patients after consuming Sucralose, as measured by metagenome analysis.

What is being tested

Daily Sucralose Consumption Study

+ Daily Sucralose Consumption Study

Other
Who is being recruted

Digestive System Diseases+3

+ Gastroenteritis

+ Gastrointestinal Diseases

From 18 to 75 Years
+25 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Interventional
Study Start: April 2024
See protocol details

Summary

Principal SponsorCase Western Reserve University
Study ContactSargun Singh, M.B.B.S.More contacts
Last updated: October 1, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 18, 2024

Actual date on which the first participant was enrolled.

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.

NCT07852273
Principal SponsorCase Western Reserve University
Study ContactSargun Singh, M.B.B.S.More contacts
Last updated: October 1, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesGastroenteritisGastrointestinal DiseasesIntestinal DiseasesCrohn DiseaseInflammatory Bowel Diseases

Criteria

7 inclusion criteria required to participate
Able to complete daily surveys and take oral nutrition
Able to record meal intake
Age range from 18 to 75 years
Capable of providing consent to participate
Show More Criteria
18 exclusion criteria prevent from participating
Antibiotic use within last 14 days
Bariatric surgery
Body mass Index < 16 kg/m or >= 40 kg/m
Change in IBD medication within past 4 weeks
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants in this group have Crohn's disease and will consume a non-nutritive sweetener called sucralose daily.

Group II

Experimental
This group consists of healthy individuals who will consume a non-nutritive sweetener, Sucralose, in the form of 2 sachets per day. The daily dose is below the acceptable daily intakes.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Recruiting

UH Minoff Health Center

Chagrin Falls, United StatesOpen UH Minoff Health Center in Google Maps
Recruiting

University Hospitals Cleveland Medical Center

Cleveland, United States
Recruiting

UH Westlake Health Center

Westlake, United States
Recruiting
3 Study Centers