Using probiotics with enteral nutrition to reduce infections after pancreatic surgery
Probiotics Combined with Enteral Nutrition on Infectious Complications After Pancreaticoduodenectomy:a Single-centre, Prospective Randomised, Open, Parallel-controlled, Superiority Study
PHASE1; PHASE2 · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · NCT06719596
This study is testing if adding probiotics to the feeding plan after pancreatic surgery can help reduce infections in patients.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (other) |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06719596 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of probiotics, specifically Bifidobacterium Bifidum, combined with enteral nutrition on reducing postoperative infectious complications in patients undergoing elective pancreaticoduodenal surgery. The study aims to enroll adult patients who meet specific eligibility criteria, including the ability to provide informed consent and a lack of recent probiotic or antibiotic use. The trial is designed to assess the safety and efficacy of this intervention in improving patient outcomes following surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients over 18 years old scheduled for elective pancreaticoduodenal surgery.
Not a fit: Patients who have recently used probiotics or antibiotics, those unable to tolerate the procedure due to health issues, or those undergoing emergency surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of postoperative infections in patients undergoing pancreatic surgery.
How similar studies have performed: While the specific combination of probiotics and enteral nutrition in this context may be novel, similar studies have shown promise in reducing postoperative complications in other surgical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients greater than 18 years of age; * Indication for elective pancreaticoduodenal surgery; * Patients who understand the nature of the trial and are willing and able to provide written consent Exclusion Criteria: . Current or recent (within the previous 1 month) use of probiotic-based products or antibiotic therapy medications. Inability to tolerate PD due to cardiopulmonary function and other parameters * Received radiotherapy before surgery * Emergency PD surgery * Pregnant and breastfeeding women
Where this trial is running
Nanjing, Jiangsu
- 321 Zhongshan Road, Nanjing Gulou Hospital, Gulou District, Nanjing, Jiangsu Province, China — Nanjing, Jiangsu, China (RECRUITING)
Study contacts
- Study coordinator: Fu XU FUXU
- Email: fuxunju2012@163.com
- Phone: +86 182 0518 8516
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infectious Complications