Health TrialsbyHealthPanel

Non-nutritive Sweeteners in Inflammatory Bowel Disease

ConditionsInflamatory Bowel DiseaseCrohn Disease (CD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity Hospitals Cleveland Medical Center

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 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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

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 intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Crohn's participantsExperimental treatment 1 intervention
Group B: Healthy ControlsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change 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

Secondary outcomes

1

Change in Fecal Myeloperoxidase activity (MPO)

Quantify the change in fecal MPO

Time frame
Baseline, three weeks pre-intervention, three weeks post-intervention
2

Change in Fecal Calprotectin

Quantify the change in fecal calprotectin

Time frame
Baseline, three weeks pre-intervention, three weeks post-intervention
3

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)
4

Change in C-reactive protein (CRP)

Quantify change in CRP

Time frame
Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospitals Cleveland Medical Center

Lead sponsor

Crohn's and Colitis Foundation

Collaborator

Source ClinicalTrials.gov
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