Case Western Reserve University
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 Inflammatory Bowel Disease (IBD), compared to healthy non-IBD individuals. We will focus on studying IBD patients affected with Crohn's Disease (CD) as a proof of principle that could be tested later in other IBD subtypes (ulcerative colitis or others specific surgical conditions).
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.
Inclusion Criteria: * Age range from 18 to 75 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 Irritable Bowel Disease 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 partic…
Participants will consume 2 sachets/day during the exposure period resulting in the following daily dose: sucralose 2.5mg/kg. This dose is below the acceptable daily intakes (ADI) of 5mg/kg.
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