Verification of the effect of lubiprostone on intestinal permeability in healthy volunteers
- Conditions
- Healthy Volunteers
- Registration Number
- JPRN-UMIN000017342
- Lead Sponsor
- Yokohama City University School of Medicine Department of Gastroenterology and Hepatology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 35
Not provided
1)Persons who have received NSAIDs within 3 months before obtaining the consent (excluding topical administration of NSAIDs) 2)Persons with history of food or drug allergy (diclofenac sodium, lubiprostone, etc.) or who are suspected of such allergy 3)Persons with current or history of serious cardiovascular/vascular, hematological, respiratory, liver, kidney, gastrointestinal, or neuropsychiatric disease 4)Persons who are taking proton pump inhibitors (PPIs), antibiotics, or intestinal drugs (excluding topical administration of antibiotics) 5)Persons who have participated in other clinical studies and received the study drug, etc. within 1 month prior to the start of this study (calculated from the administration date of the study drug) 6)Persons who were judged by the investigator, etc. to be inappropriate as a subject for this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Permeability of the small intestine using the lactulose/mannitol test
- Secondary Outcome Measures
Name Time Method Endotoxin activity in blood, changes in the intestinal flora