Skip to content

Do synbiotics reduce infections after bowel surgery?

Do perioperative synbiotics reduce postoperative infectious complications in patients undergoing elective colorectal resection?

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623001315606
Enrollment
209
Registered
2023-12-15
Start date
2024-06-06
Completion date
2025-07-17
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Bowel surgery is a common procedure and is associated with relatively high rates of postoperative infections which results in longer hospital stays and increased costs. Probiotics are thought of as 'beneficial bacteria', and prebiotics are thought of as 'food for probiotics'. Synbiotics are a combination of probiotics and prebiotics. Some studies have been published which suggest that synbiotics are associated with improved outcomes after surgery, but the evidence is not yet conclusive. This randomised clinical trial is investigating whether taking synbiotics before and after bowel surgery is associated with a decrease in postoperative infections, when compared to placebo, in the New Zealand context.

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 pr

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 staff will assist with administration of the synbiotic powder in hospital. The container will be required to be stored in a refrigerator to ensure that the synbiotic powder is stored at a temperature under 8 degrees. If the participant is discharged before two weeks after surgery, they will be given their synbiotic container to complete the two week course at home. Participants will be provided with a chart to document days of successfully taking the synbiotic powder. The synbiotic container will be collected by the researcher at the end of the participant's three week course, to assess adherence.

Sponsors

The University of Auckland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

- Adult patients undergoing elective colorectal resection for malignant or benign conditions at selected trial sites in New Zealand. - Elective colorectal resection includes surgical planning for anastomosis +/- stoma formation.

Exclusion criteria

- Patients undergoing acute or emergency operation - Patients not receiving an anastomosis - Patients undergoing surgical planning to remove all of their colon - Not enough time for patient to have 3 days or more preoperative powder (due to short time-frames between clinic and date of surgery) - Intolerance to probiotics or synbiotics - Unwilling to provide informed consent after discussions held in the participant's preferred language - Development of acute pancreatitis during the clinical trial - Severe immunosuppression with neutrophils less than 1 prior to enrollment in the clinical trial

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 15, 2026