Crohn Disease (CD), Inflamatory Bowel Disease
Conditions
Keywords
sweeteners, sucralose, inflammatory bowel disease, crohn's disease, IBD, CD, artificial sweeteners
Brief 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. 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).
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.
Interventions
OTHERSucralose (non-nutritive sweetener)
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.
Sponsors
University Hospitals Cleveland Medical Center
Crohn's and Colitis Foundation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Two groups; Crohn's and Healthy participants who undergo the same intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in fecal microbiome measured by metagenome analysis | Baseline, three weeks pre-intervention, and three weeks after intervention | Quantify the change in the fecal microbiome using metagenome analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fecal Myeloperoxidase activity (MPO) | Baseline, three weeks pre-intervention, three weeks post-intervention | Quantify the change in fecal MPO |
| Change in Fecal Calprotectin | Baseline, three weeks pre-intervention, three weeks post-intervention | Quantify the change in fecal calprotectin |
| Change in Crohn's Disease Activity Index (CDAI) | Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention) | 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. |
| Change in C-reactive protein (CRP) | Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention_ | Quantify change in CRP |
Countries
United States
Contacts
CONTACTAbigail Raffner, RD PhD
CONTACTSargun Singh, M.B.B.S.
PRINCIPAL_INVESTIGATORFabio Cominelli, MD PhD
University Hospitals Cleveland Medical Center
PRINCIPAL_INVESTIGATORAbigail Raffner, RD PhD
Case Western Reserve University
Outcome results
None listed