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NCT07769437From ClinicalTrials.govRecruiting

Non-nutritive Sweeteners in Inflammatory Bowel Disease

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

  • Inflamatory Bowel Disease
  • Crohn Disease (CD)

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
University Hospitals Cleveland Medical Center
Enrolment target
40
Started
3 February 2025
Main results due
December 2026
Study sites
3
Registry updated
25 September 2026

Can you take part?

  • Ages 18 years to 70 years.
  • Open to any sex.
  • Healthy volunteers can take part.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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

What this study is about

In the sponsor’s own words, from the registry.

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. The investigators 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 sites(3)

  • UH Minoff Health Center

    Chagrin Falls, Ohio, United States

    Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, United States

    Recruiting

  • UH Westlake Health Center

    Westlake, Ohio, United States

    Recruiting

Showing 3 of 3 sites. 3 of the 3 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07769437. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Non-nutritive Sweeteners in Inflammatory Bowel Disease | Trialion