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Could a common sweetener reshape the gut in Crohn's disease?

NCT ID NCT07769437

Knowledge-focused Sponsor: University Hospitals Cleveland Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This study investigates whether consuming sucralose, a common artificial sweetener, changes the gut microbiome in people with Crohn's disease compared to healthy individuals. Participants will consume two sachets of sucralose daily for a period, and researchers will measure changes in fecal bacteria and markers of gut inflammation. The goal is to understand if this sweetener might influence gut health in IBD.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sucralose, a non-nutritive sweetener
What this could lead to
If sucralose is found to alter gut bacteria in Crohn's disease, it could point toward dietary recommendations to help manage the condition.
What could go wrong
This is a small, early-stage study focused on microbiome changes, not clinical outcomes. Results may not apply to all IBD subtypes or lead to direct treatment changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn disease (CD) Inflamatory bowel disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UH Minoff Health Center

    RECRUITING

    Chagrin Falls, Ohio, 44122, United States

  • UH Westlake Health Center

    RECRUITING

    Westlake, Ohio, 44145, United States

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

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