Infectious ComplicationsPhase 1/22024-225-01NCT06719596
Probiotics Combined with Enteral Nutrition Reduces Postoperative Infectious Complications in PD
A Phase 1/2 study testing Bifidobacterium Bifidum Oral Capsule in people with Infectious Complications, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
Probiotics combined with enteral nutrition reduces postoperative infectious complications in PD Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infectious Complications
- What is being tested?
- Bifidobacterium Bifidum Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2024to 28 Jun 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- . 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
321 Zhongshan Road, Nanjing Gulou Hospital, Gulou District, Nanjing, Jiangsu Province, China
Nanjing, Jiangsu, 222000
fuxunju2012@163.com
About this study
Official title: Probiotics Combined with Enteral Nutrition on Infectious Complications After Pancreaticoduodenectomy:a Single-centre, Prospective Randomised, Open, Parallel-controlled, Superiority Study
Probiotics combined with enteral nutrition reduces postoperative infectious complications in PD
- Conditions
- Infectious Complications
- Being tested
- Bifidobacterium Bifidum Oral Capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium Bifidum Oral CapsuleDrug
enteral nutrition+Pre-operative + one week post-operative Oral Bifidobacterium bifidum live triple capsule, 4 capsules Oral BID
| Study group | Role | What they receive |
|---|---|---|
| Probiotics combined with enteral nutrition reduces postoperative infectious complications in PD | Experimental | enteral nutrition+Pre-operative + one week post-operative Oral Bifidobacterium bifidum live triple capsule, 4 capsules Oral BID Receives: Drug: Bifidobacterium Bifidum Oral Capsule |
| Control group | No intervention | Conventional postoperative treatment of the pancreas combined with enteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
infectious complication
- Post-operative infections: Surgical site infections (SSI): including surgical incision infections and abdominal cavity infections. (1) incision infection: purulent secretions in the incision and culture of pathogenic bacteria (2) abdominal cavity infection: diagnosis can be made by meeting one of the following criteria: ① postoperative symptoms of systemic infection (fever > 38 ° C, white blood cell count higher than the upper limit of normal values), accompanied by abdominal distension, abdominal pain, and signs of peritonitis; ② abdominal drainage or puncture drainage fluid is purulent fluid, positive bacteriological culture results; ③ ultrasound, CT and other imaging tests or re-operation to confirm the presence of oozing or encapsulated abscess in the abdominal cavity; ③ ultrasound, CT and other imaging tests or re-operation to confirm the presence of oozing or encapsulated abscess. (iii) ultrasound or CT imaging or re-surgical confirmation of the presence of intra-abdominal ex
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start10 May 2024
- Primary completion10 Jun 2025 (estimated)
- Study completion28 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious ComplicationsStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719596
- Sponsor's protocol ID
- 2024-225-01
- Acronym
- 2024-225-01
- Status last verified
- Nov 2024
- First submitted
- 2 Dec 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics Combined with Enteral Nutrition on Infectious Complications After Pancreaticoduodenectomy:a Single-centre, Prospective Randomised, Open, Parallel-controlled, Superiority Study
- ClinicalTrials.gov ID
- NCT06719596
- Acronym / sponsor ID
- 2024-225-01 / 2024-225-01
- Conditions
- Infectious Complications
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 10 May 2024 (actual)
- Primary completion
- 10 Jun 2025 (estimated)
- Study completion
- 28 Jun 2025 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Probiotics combined with enteral nutrition reduces postoperative infectious complications in PD
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics combined with enteral nutrition reduces postoperative infectious complications in PD | Experimental | Drug: Bifidobacterium Bifidum Oral Capsuleenteral nutrition+Pre-operative + one week post-operative Oral Bifidobacterium bifidum live triple capsule, 4 capsules Oral BID |
| Control group | No intervention | –Conventional postoperative treatment of the pancreas combined with enteral nutrition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- . 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bifidobacterium Bifidum Oral Capsuleenteral nutrition+Pre-operative + one week post-operative Oral Bifidobacterium bifidum live triple capsule, 4 capsules Oral BID | Drug | Probiotics combined with enteral nutrition reduces postoperative infectious complications in PD |
Primary outcome
infectious complication
Time frame: 30 days after surgery
1. Post-operative infections: Surgical site infections (SSI): including surgical incision infections and abdominal cavity infections. (1) incision infection: purulent secretions in the incision and culture of pathogenic bacteria (2) abdominal cavity infection: diagnosis can be made by meeting one of the following criteria: ① postoperative symptoms of systemic infection (fever > 38 ° C, white blood cell count higher than the upper limit of normal values), accompanied by abdominal distension, abdominal pain, and signs of peritonitis; ② abdominal drainage or puncture drainage fluid is purulent fluid, positive bacteriological culture results; ③ ultrasound, CT and other imaging tests or re-operation to confirm the presence of oozing or encapsulated abscess in the abdominal cavity; ③ ultrasound, CT and other imaging tests or re-operation to confirm the presence of oozing or encapsulated abscess. (iii) ultrasound or CT imaging or re-surgical confirmation of the presence of intra-abdominal ex
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bifidobacterium Bifidum Oral Capsule in people with Infectious Complications, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fu XU FUXU (+86 182 0518 8516, fuxunju2012@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
infectious complication (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.