MS-20 on Gut Microbiota and Risk/Severity of Cachexia in Pancreatic Cancer Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cachexia
- Chemotherapy Effect
- Pancreatic Cancer
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 20 years and 75 years
- Gender
- Both males and females
Description
This is a double-blind, placebo-controlled, investigator-initiated randomized trial to evaluate the effects of MS-20 on gut microbiota and risk/severity of cachexia in patients receiving chemotherapy for pancreatic cancer. Approximately 40 subjects who meet the criteria will be enrolled into the stu...
This is a double-blind, placebo-controlled, investigator-initiated randomized trial to evaluate the effects of MS-20 on gut microbiota and risk/severity of cachexia in patients receiving chemotherapy for pancreatic cancer. Approximately 40 subjects who meet the criteria will be enrolled into the study. The total of study comprises of a 28 days screening period, a 12-week treatment period and a 8-week follow-up period. Potential candidates should provide signed informed consent forms before starting any screening activities. MS-20 or placebo will be orally administered twice per day in treatment period. All medications (especially antibiotics) should be recorded and documented during the study period. The investigator may withdraw a subject from the study if any of the following conditions occurs: Subjects who experiences a serious adverse event (SAE) or intolerable adverse event (AE), or laboratory safety assessments reveal clinically significant hematological or biochemical changes from baseline values. The subject would like to withdraw consent and discontinue from the study at any time, for any reason, without any influence on further treatment. (Patients who withdraw or terminate early from study should proceed to EOT visit for safety evaluation.)
Tracking Information
- NCT #
- NCT04600154
- Collaborators
- Microbio Co Ltd
- Investigators
- Principal Investigator: Wei-Chih Liao, MD/PhD Department of Internal Medicine, National Taiwan University Hospital