Non-nutritive Sweeteners in Inflammatory Bowel Disease
Recruiting · NCT07769437 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospitals Cleveland Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
Sucralose (non-nutritive sweetener)
What this trial is about
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).
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
3 locations listed across 1 US state.
- UH Minoff Health Center - Chagrin Falls, Ohio, United States
- University Hospitals Cleveland Medical Center - Cleveland, Ohio, United States
- UH Westlake Health Center - Westlake, Ohio, United States