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. We 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).
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
40
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.
UH Minoff Health Center
Chagrin Falls, Ohio, United States
RECRUITINGUniversity Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
RECRUITINGUH Westlake Health Center
Westlake, Ohio, United States
RECRUITINGChange in fecal microbiome measured by metagenome analysis
Quantify the change in the fecal microbiome using metagenome analysis
Time frame: Baseline, three weeks pre-intervention, and three weeks after intervention
Change in Fecal Myeloperoxidase activity (MPO)
Quantify the change in fecal MPO
Time frame: Baseline, three weeks pre-intervention, three weeks post-intervention
Change in Fecal Calprotectin
Quantify the change in fecal calprotectin
Time frame: Baseline, three weeks pre-intervention, three weeks post-intervention
Change in Crohn's Disease Activity Index (CDAI)
Quantify the change in Crohn's Disease Activity Index. The Crohn's Disease Activity Index (CDAI) is a validated clinical instrument used to quantify Crohn's disease activity. It evaluates 8 components over a 7-day period: number of liquid or very soft stools, severity of abdominal pain, general well-being, extraintestinal complications, use of antidiarrheal medications, presence of an abdominal mass, hematocrit levels, and body weight deviation. Each component is multiplied by a specific weighting factor and summed to calculate a total score. Total scores range from 0 to approximately 600 points, where lower scores indicate lower disease activity. A score of \<150 indicates clinical remission, while a score of \>450 indicates severe disease. A negative change from baseline indicates clinical improvement.
Time frame: Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention)
Change in C-reactive protein (CRP)
Quantify change in CRP
Time frame: Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention_
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