Trial Details

Recruiting
Basic Information
Clinical ID c2123
Identifier ACTRN12623001315606
Trial Title Do perioperative synbiotics reduce postoperative infectious complications in patients undergoing elective colorectal resection?
Trial URL Visit Original Page
Study Information
Study Results

No results available

Conditions Colorectal disease;Postoperative infection;Colorectal cancer;Inflammatory bowel disease; Colorectal disease Postoperative infection Colorectal cancer Inflammatory bowel disease;Surgery - Other surgery;Infection - Studies of infection and infectious agents;Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon;Oral and Gastrointestinal - Inflammatory bowel disease;Cancer - Bowel - Back passage (rectum) or large bowel (colon)
Interventions The intervention is a synbiotic powder manufactured by the Sydney based company ProGood. Synbiotics are a combination of probiotics and prebiotics. Probiotics and synbiotics are classified as food supplements, not medicines. The selected synbiotic product is called 'ProGood Original' and it contains the following probiotics and prebiotics: - 15 billion Lactobacillus acidophilus - 15 billion Bifidobacterium lactis - Arabinoglobulin - Inulin This synbiotic product was selected because of the presence of two commonly used probiotic species (Lactobacillus acidophilus and Bifidobacterium lactis) that appeared to be less prevalent as sources of bacteraemia in case reports, as opposed to other probiotic species. Of note, probiotic-induced bacteraemia is a rare outcome with documentation in isolated case reports and often in patients with severe immunosuppression. Nonetheless, we wanted to focus on selecting a synbiotic product that was as safe as possible for our randomised controlled trial. Participants randomised to the intervention group will be given a plain container containing 105g of synbiotic powder, and a scoop. They will be asked to take orally 5 grams (approximately 1 heaped teaspoon) synbiotic powder mixed in with a glass of water once daily for 1 week before surgery, in their own home. They will not take the synbiotic powder on the day of surgery, but they will bring the container to hospital for storage. They will take the synbiotic powder for two weeks after surgery. If they are nil by mouth after surgery due to a complication such as an ileus, they will not be required to take the powder on the days that they are nil by mouth. Instead, they will return to taking it when they are able to tolerate oral medications. Nursing staf
Participant Information
Sponsor The University of Auckland
City -
Country/Region New Zealand
Enrollment Criteria
Sex Requirement ALL
Age Requirement ADULT, ELDER, OLDER_ADULT
Study Design
Study Type Interventional
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -