The purpose of this study is to investigate the safety and effectiveness of a new investigational drug in women for the treatment of diarrhea-predominant irritable bowel syndrome.  The investigational drug is a natural product taken from a plant that grows in South America.  The study medication will be administered orally twice a day.  Subjects will be not able to remain on certain standard IBS medications (anti-diarrheals) while participating in the study.  The total duration of the study is 18 weeks. 

The study requires five study visits that include physical exams, ECG, blood draws, laboratory studies, and a colon procedure (such as a colonoscopy or flexible sigmoidoscopy if an appropriate procedure has not been performed in the last 5 years.) Participants will be asked to make entries into a touch-tone telephone diary on a daily basis.

Participants must meet all of the following criteria:

·         Females at least 18 years of age

·         Diagnosis of diarrhea predominant Irritable Bowel Syndrome

·         Willingness to make daily calls on a touch-tone telephone

·         Willingness to have an endoscopic and/or radiologic bowel evaluation, if you have not received one in the past 5 years.

·         Willingness to take an approved method of birth control (if required)

Participants CANNOT meet any of the following criteria:

·         Serious medical or surgical conditions

·         Colon Cancer, Crohns Disease or Ulcerative Colitis

·         Pregnant or breast feeding

For information on this study please contact:

Carol Ward

Phone #: 336-323-3229 

carol.ward@mosescone.com

 Site Address:  LeBauer Research Associates
  520 N. Elam Avenue
  Greensboro, NC  27403

Principal Investigator at this site:  Robert D. Kaplan, M.D.

This clinical trial is sponsored by Trine Pharmaceuticals, Inc.