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Do Synbiotics Reduce Infections in Foregut Surgery?

Do Synbiotics Reduce Infections in Adults undergoing Major Foregut Surgery?

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000295842
Acronym
DISCO
Enrollment
258
Registered
2021-03-18
Start date
2023-01-30
Completion date
Unknown
Last updated
2023-03-27

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

Conditions

None listed

Brief summary

The perioperative administration of synbiotics (a combination of probiotics and prebiotics) has been associated with a relative risk reduction in postoperative infectious complications of 50% for patients undergoing general surgery. Major foregut surgery includes oesophagectomy, gastrectomy, distal pancreatectomy, pancreaticoduodenectomy, and liver resections. These operations have a relatively high incidence of postoperative infections complications. From our locally maintained prospective database at St Vincent’s Hospital, the rate of infectious complications following major foregut surgery is 31%. This patient population will have preoperative dysbiosis due to the underlying pathology, neoadjuvant chemotherapy and radiotherapy, medications including antibiotics, weight loss, stress, and diet. They could gain significantly from interventions aimed at improving their microbiota and clinical outcomes. We propose a randomised, placebo-controlled, double-blinded trial to assess perioperative synbiotic administration's effectiveness on reducing postoperative infections in major foregut surgery patients. Additional clinical outcomes will assess the impact of synbiotics on time to first bowel movement, length of stay in intensive care, length of hospital stay, antibiotic therapy duration, and mortality. We will also perform a scientific examination of faecal microbiota and assess intestinal permeability and systemic inflammation. By examining whether changes in clinical outcomes are correlated with alterations in these measures, we aim to understand the mechanism of action of synbiotics further.

Interventions

Progood premium probiotics and prebiotic preparation. It contains 30 billion of the probiotic strains Lactobacillus acidophilus, and Bifidobacterium lactis. It contains the prebiotics as folllows: - 1.4 grams of dietary fibre (aribinogalactan) - 1.3 grams of Inulin - 1.8 grams of Trehalose Prepared as a 5g scoop of the powdered concentrate that is reconstituted with water and taken enterally. Participants will take 1 scoop daily for 14 days prior to surgery, and 1 scoop daily for 14 days after

Progood premium probiotics and prebiotic preparation. It contains 30 billion of the probiotic strains Lactobacillus acidophilus, and Bifidobacterium lactis. It contains the prebiotics as folllows: - 1.4 grams of dietary fibre (aribinogalactan) - 1.3 grams of Inulin - 1.8 grams of Trehalose Prepared as a 5g scoop of the powdered concentrate that is reconstituted with water and taken enterally. Participants will take 1 scoop daily for 14 days prior to surgery, and 1 scoop daily for 14 days after the surgery. Patients are provided with a handout with checkboxes for them to indicate which days the treatment was ingested.

Sponsors

Amanda Nikolic
Lead SponsorIndividual

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

Patients eligible for participation in this trial include all adult patients undergoing elective major foregut surgery at St Vincent’s Public and St Vincent’s Private hospital in Melbourne. Inclusion Criteria - Adults older then 18 years old - Scheduled for any major foregut operation for any indication including oesophagectomy, total gastrectomy, subtotal gastrectomy, pancreaticoduodenectomy, any type of pancreatectomy, splenectomy, liver resection, major bile duct resection

Exclusion criteria

Exclusion Criteria - Inoperable tumours resulting in major resection not proceeding - Patient refusal to participate in the study - Emergency Surgery - Allergy to probiotics or prebiotics

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026