Use of Rectal Dialysis Technique to Measure Rectal 5-ASA Levels in Healthy Volunteers Receiving Asacol
- Conditions
- Ulcerative Colitis
- Interventions
- Drug: Rectal dialysis
- Registration Number
- NCT04032652
- Lead Sponsor
- NorthShore University HealthSystem
- Brief Summary
The investigators plan to develop a novel method of estimating 5-ASA levels in the rectum at a mucosal level using in vivo rectal dialysis technique towards the eventual goal of determining the optimal dosing of Asacol® that would provide therapeutic levels of 5-ASA in the left colon.
- Detailed Description
Asacol® is mesalazine in a pH-dependent tablet (Eudragit S) that remains intact until reaching the terminal ileum. The tablet dissolves at a pH 7 or greater, allowing mesalazine release in the terminal ileum and throughout the colon; hence, it would be anticipated that this form of 5-ASA will produce higher concentrations in the left colon in patients with active ulcerative colitis compared to other immediate release forms of 5-ASA. However, preliminary research using dynamic computer modeling and simulation predicted that patients with active ulcerative colitis (characterized by an increased stool frequency) treated with Asacol® and Lialda (another delayed release formulation) will achieve very low 5-ASA levels in the sigmoid colon and rectum. The model predicts that these 5-ASA preparations will be relatively ineffective in treating the left side of the colon in active ulcerative colitis.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
- Eligible subjects would be healthy males and females
- 18-45 years of age (inclusive)
- Within 20% of normal body weight at screening
- Who are able to give written informed consent.
- History of any chronic illness
- Evidence of significant organic or psychiatric disease on a brief health questionnaire
- A history or presence of any condition causing malabsorption or an effect on gastrointestinal motility
- A history of any gastrointestinal surgery
- A history of acute or chronic renal insufficiency
- Pre existing liver disease
- A history of severe allergic reaction to salicylates, aminosalicylates or any of the ingredients of Asacol® tablets or a history of multiple food/drug allergies or if they are pregnant or lactating.
- Subjects will be required to refrain from any prescription or nonprescription drug or herbal products except their birth control medications for gastrointestinal disorders for 7 days prior to dosing and during the study, till its completion at the end of the fifth visit.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1200 mg Asacol once daily for 1 week Rectal dialysis Rectal dialysis will be done after 1 week on 1200 mg asacol 2400 mg Asacol once daily for 1 week Rectal dialysis Rectal dialysis will be done after 1 week on 2400 mg asacol
- Primary Outcome Measures
Name Time Method Detection of 5-ASA 2 weeks after starting Asacol 5-ASA to be measured using rectal dialysis technique in-vivo
- Secondary Outcome Measures
Name Time Method Change in Detected 5-ASA With Change in Ingested Asacol Dose 5 weeks after starting study Comparison of 2-week and 5-week 5-ASA as measured thorugh rectal dialysis