Investigating the Effect of the Non-nutritive Sweetener Sucralose in Inflammatory Bowel Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCase Western Reserve University
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Short bowel syndrome
Hospitalized patients
Individuals who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, dementia patients
Known drug abuse
Trial design
Design model
Parallel
Treatments tested in this trial
Sucralose (non-nutritive sweetener)
Other interventionParticipants 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Crohn's participantsExperimental treatment 1 intervention
Group B: Healthy ControlsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in fecal microbiome
Quantify the change in the fecal microbiome as measured by metagenome analysis
Time frame
Baseline, 14 days post-baseline, and 21 days post-interventionSecondary outcomes
1
Change in Fecal Myleoperoxidase activity (MPO)
Quantify the change in fecal MPO
Time frame
Baseline, 14 days post-baseline, and 21 days post-intervention2
Change in Fecal Calprotectin
Quantify the change in fecal calprotectin
Time frame
Baseline, 14 days post-baseline, and 21 days post-intervention3
Change in Short Crohn's Disease Activity Index (sCDAI)
Quantify before/after intervention self-reported indices for Crohn's Disease patients using the sCDAI. The sCDAI, a shortened version of the Crohns Disease Activity Index, is a 4-question survey with abdominal pain, diarrhea frequency, and general well-being domains, reported over the previous 7 days. Score scale for sCDAI is: \<150 define remission, 150-219 mild activity, 220-450 moderate activity, \>450 severe activity.
Time frame
Baseline, 14 days post-baseline, and 21 days post-intervention4
Change in Crohns Disease Activity Index (CDAI)
Quantify before/after intervention indices for Crohn's Disease patients using the CDAI. CDAI score is: \<150 define remission, 150-219 mild activity, 220-450 moderate activity, \>450 severe activity.
Time frame
Baseline, 14 days post-baseline, and 21 days post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Case Western Reserve University
Lead sponsor
Crohn's and Colitis Foundation
Collaborator
Source ClinicalTrials.gov