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An Open-Label, Pilot Clinical Trial To Test The Efficacy Of A Suspension of Freeze-dried Microbiota In Patients Undergoing Colon Resection
Status: Recruiting
We have determined that the microbes (bacteria) in the colon can play a role in causing and preventing complications of colon surgery. While the surgical bowel prep before surgery eliminates the harmful bacteria, it also eliminates the beneficial bacteria that aid wound healing. The purpose of this study is to determine if we can restore the presence of good bacteria (also known as ‘intestinal microbiota’) in the colon by transplanting them from a healthy donor.
Sex: Male or Female
Age Group: 18 years and over
Inclusion Criteria:
• 18 to 75 years old
• having surgery for unresectable polyps, early-stage colon cancer (Stage 1 or 2) and don't expect to have chemotherapy or diverticulitis
• able to provide fecal samples
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:
• history of inflammatory bowel disease (Crohn's, Ulcerative Colitis)
• women who are pregnant or breastfeeding
• presence of ileostomy or colostomy
• history of solid organ or bone marrow transplant
• history of celiac disease
• receiving cancer chemotherapy, immunotherapy, or radiation
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions:
Cancer, Digestive & Liver Health
Keywords:
bowel resection, bowel surgery, Clinics and Surgery Center (CSC), colon cancer
Study Contact: Kathryn Vera - giero002@umn.edu
Principal Investigator: Cyrus Jahansouz
Phase: PHASE1
IRB Number: STUDY00023336
See this study on ClinicalTrials.gov