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Non-nutritive Sweeteners in Inflammatory Bowel Disease

RecruitingHealthy volunteers welcome

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

Who can join

Ages 18 to 70 · All sexes · Healthy volunteers welcome

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

About the study

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).

What is being tested

Sponsor: University Hospitals Cleveland Medical Center · Participants: 40 · Started: Feb 3, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07769437

Locations in the U.S.

OhioUH Minoff Health Center, Chagrin Falls
University Hospitals Cleveland Medical Center, Cleveland
UH Westlake Health Center, Westlake

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.