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NCT07769437NARecruitingAccepts Healthy Volunteers

Non-nutritive Sweeteners in Inflammatory Bowel Disease

University Hospitals Cleveland Medical Center

Start Date

2/3/2025

Completion Date

12/1/2026

Summary

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).

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.

Eligibility Criteria

Age Range: 18 years to 70 years

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

Interventions

OTHER

Sucralose (non-nutritive sweetener)

Interested in This Trial?

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Conditions

Inflamatory Bowel DiseaseCrohn Disease (CD)

Locations

UH Minoff Health Center

Chagrin Falls, Ohio 44122

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

UH Westlake Health Center

Westlake, Ohio 44145

United States