Overview
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).
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.
Eligibility
Inclusion Criteria:
- 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.
- Able to complete daily surveys and take oral nutrition
- Able to record meal intake
- Healthy controls with no diagnosis of Irritable Bowel Disease 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 patient's cooperation.
- Existing pregnancy or lactation
- History of \<1 natural bowel movements per 3 consecutive days
- Unable to access technology that permits the daily completion of study related activities
- Change in IBD medication within past 4 weeks
- Body mass Index \<16 kg/m or ≥40 kg/m
- Documented C.difficile colitis within four weeks of screening
- Bariatric surgery
- Phenylketonuria
