Using probiotics with enteral nutrition to reduce infections after pancreatic surgery
Official title: Probiotics Combined with Enteral Nutrition on Infectious Complications After Pancreaticoduodenectomy:a Single-centre, Prospective Randomised, Open, Parallel-controlled, Superiority Study
Run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · NCT06719596 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 68 (estimated) |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Status | Recruiting |
| Started | May 10, 2024 |
| Main results expected | June 10, 2025 |
| Study ends | June 28, 2025 |
| Registry record updated | December 6, 2024 |
| Trial ID | NCT06719596 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adult patients over 18 years old scheduled for elective pancreaticoduodenal surgery.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.