None listed
Conditions
Brief summary
The study aims to determine the health benefits of oral probiotics in improving the post-operative recovery following appendicectomy for acute appendicitis. Children with appendicitis will randomly allocated to receive probiotics or placebo for 1 month following appendicectomy. We will collect information regarding post-operative recovery (e.g. return to normal physical activities, number of bowel actions, etc.) to confirm if probiotics might be beneficial following surgery and provide a quicker recovery.
Interventions
Children (4-13 -years) with simple (non-perforated) and complicated (perforated) appendicitis will be randomly allocated to the intervention group (probiotic) following appendicectomy.
Children with simple (non-perforated) appendicitis will undergo appendectomy followed by 2 post-operative doses of intravenous antibiotics; patients will receive once daily oral probiotic supplement or placebo control for 4 weeks.
Children with complicated (perforated appendicitis) will undergo appendectomy follow
Children (4-13 -years) with simple (non-perforated) and complicated (perforated) appendicitis will be randomly allocated to the intervention group (probiotic) following appendicectomy. Children with simple (non-perforated) appendicitis will undergo appendectomy followed by 2 post-operative doses of intravenous antibiotics; patients will receive once daily oral probiotic supplement or placebo control for 4 weeks. Children with complicated (perforated appendicitis) will undergo appendectomy followed by 5 days of intravenous antibiotics. Patients will receive once daily oral probiotic supplement or placebo control for 4 weeks. Probiotics will be taken orally and provided in sachets (1.5 g in total) and composed of: - 50% L. helveticus (R52); (CFU count =2.5×10*9) - 12.5% B. bifidum (R71); (CFU count =0.625×10*9) - 12.5% B. longum subsp. infantis (R33); (CFU count =0.625×10*9) - 25% breve (M16V); (CFU count =1.25×10*9) Duration of administration will be 4 weeks, starting on the day the patients will have their first bowel motion following surgery. Adherence to the intervention will be confirmed at the time when patients are seen for the post-operative follow-up and by return of unused probiotics/placebo
Sponsors
Monash Health
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
4 Years to 13 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged 4-13 years 2. No associated co-morbidities (ASA 1) 3. Undergoing laparoscopic appendicectomy for simple (non-perforated) or complicated (perforated) appendicitis
Exclusion criteria
1. Any associated co-morbidities (ASA 2 and above as confirmed independently by the anaesthetist and surgeon prior to appendicectomy; if disagreement a third doctor, anaesthetist or surgeon, will be consulted) 2. Prior antibiotic use within the previous 3 months 3. Previous history of significant gastrointestinal conditions (e.g. IBD, etc.) or metabolic conditions (e.g. diabetes mellitus) even if well controlled 4. Immunocompromised patients or patients taking immunosuppressant drugs 5. Overseas travel within the last 3 months
Outcome results
None listed