Acute PancreatitisNCT06639516
Therapeutic Effect of Bifidobacterium Longum in Patients with Acute Pancreatitis: a Randomized, Double-Blind, Placebo-Controlled Trial
A study testing Bifidobacterium longum and Standard clinical treatment in people with Acute Pancreatitis, run by The First Affiliated Hospital of Nanchang University at 1 site in China.
Trial summary
The purpose of this clinical trial is to investigate the impact of Bifidobacterium longum(BL) on the clinical prognosis of patients with acute pancreatitis(AP), to analyze the correlation between BL and intestinal barrier function, as well as the gut microbiota, and to observe adverse reactions and risks in patients… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- Bifidobacterium longum and Standard clinical treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2025to 1 Dec 2025
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 year;
- The diagnosis of acute pancreatitis according to the revised Atlanta classification;
- The onset time of acute pancreatitis is within 48 hours;
- APACHE II score of ≥8, or C-reactive protein \> 150 mg/L, or SIRS score of ≥3;
- Signed the informed consent.
Who cannot join
- Within 48 hours of onset, there is multi-organ failure;
- Use of probiotics within the last month;
- Pancreatitis following endoscopic retrograde cholangiopancreatography (ERCP);
- Intra-operative diagnosis;
- Infection/sepsis caused by a second disease;
- Malignancy;
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- Immunocompromised patients;
- Pregnancy and/or lactation;
- Allergy to Bifidobacterium longum.
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
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Cong He, PhD, +8613807032823, hecong.1987@163.com
About this study
The purpose of this clinical trial is to investigate the impact of Bifidobacterium longum(BL) on the clinical prognosis of patients with acute pancreatitis(AP), to analyze the correlation between BL and intestinal barrier function, as well as the gut microbiota, and to observe adverse reactions and risks in patients with AP after the use of BL.
Participants will be randomly assigned to two groups: the intervention group and the control group. They will receive:
Read more
- Intervention group: Standard clinical treatment + BL capsules (10^10 CFU), twice a day, for a total of 14 days;
- Control group: Standard clinical treatment + placebo capsules, for a total of 14 days.
A total of 60 patients will be included in this study.
Read the detailed description
Rationale:The impairment of the intestinal mucosal barrier in patients with acute pancreatitis (AP) plays a crucial role in the progression to severe AP(SAP). Our previous research found that the early gut microbiota structure of AP patients is significantly different from that of healthy individuals, characterized by a marked increase in the relative abundance of conditional pathogens such as Escherichia coli and Shigella, while beneficial bacteria that produce short-chain fatty acids, such as Bifidobacterium, are significantly reduced, especially in patients with SAP. Bifidobacterium longum (BL), a well-known probiotic, has been used to treat a variety of diseases. In our previous animal experiments, we found that BL could alleviate pancreatic damage and inflammatory responses in AP mice and regulate the balance of the gut microbiota. Based on these findings, this study aims to assess the impact of BL on the clinical prognosis of AP patients through a randomized controlled trial, in order to provide a scientific basis for the application of BL in the treatment of AP and to further explore its potential clinical value.
Objective: The purpose of this clinical trial is to investigate the impact of BL on the clinical prognosis of patients with AP, to analyze the correlation between BL and intestinal barrier function, as well as the gut microbiota, and to observe adverse reactions and risks in patients with AP after the use of BL.
Study design: Single-center, randomized, double-blind, placebo-controlled study.
Study population:60 adult patients with acute pancreatitis. Intervention: The intervention group receives standard clinical treatment plus BL capsules (10^10 CFU), twice a day, for a total of 14 days; the control group receives standard clinical treatment plus placebo capsules, for a total of 14 days.
Main study parameters/endpoints: The primary endpoint is the number of days without SIRS within 14 days; the secondary endpoints include infectious complications (including fungal infections), parameters related to systemic inflammatory response, intestinal barrier function and gut microbiota composition, indicators related to recovery of intestinal function, antibiotic use, laboratory-related indicators, and clinical outcomes.
Safety: Throughout the study (or afterwards), treatment-emergent adverse events (TEAEs) were recorded, including gastrointestinal adverse reactions (abdominal pain, nausea, vomiting, bloating, or diarrhea) and allergic reactions, and adverse events that led to discontinuation of the study drug were documented.
- Conditions
- Acute Pancreatitis
- Being tested
- Bifidobacterium longum, Placebo, Standard clinical treatment
- Keywords
- acute pancreatitis, Probiotics
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium longumDietary supplement
Bifidobacterium longum
PlaceboDietary supplement
Placebo
Standard clinical treatmentCombination product
Fasting, gastrointestinal decompression, rehydration, inhibition of pancreatic fluid and pancreatic enzyme secretion, improvement of microcirculation, and support of organ function if organ dysfunction occurs at a later stage (mechanical ventilation, continuous renal replacement therapy, and the use of vasoactive drugs).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Bifidobacterium longum capsules (10^10 CFU) twice daily for 14 days Receives: Dietary Supplement: Bifidobacterium longum; Combination Product: Standard clinical treatment |
| Placebo group | Placebo comparator | Placebo capsules twice daily for 14 days Receives: Dietary Supplement: Placebo; Combination Product: Standard clinical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of days without SIRS within 14 days
Patients were randomized into the study group and remained free of SIRS up to 14 days after enrollment, with the total number of SIRS-free days counted
Measured: From randomization to 14 days after treatment
Secondary outcomes (16)
Infectious complications
The occurence of infected pancreatic necrosis, bacteremia, pneumonia, urosepsis, and/or infected ascites，including fungal infections
Measured: During the whole study period including follow-up of 90 days
Intestinal barrier function
Plasma D-lactate(D-lac）
Measured: Through study completion, an average of 1 year
Intestinal barrier function
Diamine oxidase activity(DAO)
Measured: Through study completion, an average of 1 year
Intestinal barrier function
Plasma endotoxin levels
Measured: Through study completion, an average of 1 year
Gut microbiota composition
Fecal samples were collected from patients prior to the start of treatment, as well as on days 3, 7, and 14 after treatment. Subsequently, DNA was extracted from the feces, and the DNA was fragmented by Covaris M220 to screen for fragments of approximately 350 bp to be constructed into paired-end (Paired-End) DNA libraries. Next, libraries were constructed using NEXTFLEX Rapid DNA-Seq. Finally, these libraries were subjected to macro-genomic sequencing for in-depth analysis of microbial community structure and function in the samples.
Measured: Baseline , 3 days，7 days and 14 days of treatment
Systemic inflammatory response parameters (SIRS)
The incidence of persistent SIRS (lasting ≥48 hours)
Measured: Through study completion, an average of 1 year
Systemic inflammatory response parameters (SIRS)
Trends in SIRS score changes
Measured: Through study completion, an average of 1 year
Systemic inflammatory response parameters (SIRS)
Trends in CRP level changes
Measured: Through study completion, an average of 1 year
Gut function recovery-related indicators
Improvement in abdominal signs
Measured: Through study completion, an average of 1 year
Antibiotic usage
The number of days of antibiotic use
Measured: Through study completion, an average of 1 year
Mortality
Occurence of death
Measured: During the whole study period including follow-up of 90 days
(New onset) transient/persistant (multiple) organ failure
The occurence of (new onset) transient/persistant (multiple) organ failure
Measured: During the whole study period including follow-up of 90 days
Disease severity according to the revised Atlanta Classification
Disease severity according to the revised Atlanta Classification
Measured: During the whole study period including follow-up of 90 days
Length of hospital and/or ICU stay
Measured in days
Measured: Through study completion, an average of 1 year
The need (and number of) for surgical, endoscopic or radiologic interventions
The need (and number of) for surgical, endoscopic or radiologic interventions
Measured: During the whole study period including follow-up of 90 days
Readmissions
The occurrence and number of readmissions
Measured: During the whole study period including follow-up of 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start15 Feb 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Nanchang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lingyu Luo, The First Affiliated Hospital of Nanchang University
- Investigators
- Cong He, PhD, Principal investigator, The First Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639516
- Sponsor's protocol ID
- Bifidobacterium Longum
- Status last verified
- Feb 2025
- First submitted
- 2 Oct 2024
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Bifidobacterium Longum in Patients with Acute Pancreatitis: a Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT06639516
- Acronym / sponsor ID
- Bifidobacterium Longum
- Conditions
- Acute Pancreatitis
- Keywords
- acute pancreatitis, Probiotics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 15 Feb 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 15 Oct 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.
The purpose of this clinical trial is to investigate the impact of Bifidobacterium longum(BL) on the clinical prognosis of patients with acute pancreatitis(AP), to analyze the correlation between BL and intestinal barrier function, as well as the gut microbiota, and to observe adverse reactions and risks in patients with AP after the use of BL.
Participants will be randomly assigned to two groups: the intervention group and the control group. They will receive:
- Intervention group: Standard clinical treatment + BL capsules (10^10 CFU), twice a day, for a total of 14 days;
- Control group: Standard clinical treatment + placebo capsules, for a total of 14 days.
A total of 60 patients will be included in this study.
Detailed description
Rationale:The impairment of the intestinal mucosal barrier in patients with acute pancreatitis (AP) plays a crucial role in the progression to severe AP(SAP). Our previous research found that the early gut microbiota structure of AP patients is significantly different from that of healthy individuals, characterized by a marked increase in the relative abundance of conditional pathogens such as Escherichia coli and Shigella, while beneficial bacteria that produce short-chain fatty acids, such as Bifidobacterium, are significantly reduced, especially in patients with SAP. Bifidobacterium longum (BL), a well-known probiotic, has been used to treat a variety of diseases. In our previous animal experiments, we found that BL could alleviate pancreatic damage and inflammatory responses in AP mice and regulate the balance of the gut microbiota. Based on these findings, this study aims to assess the impact of BL on the clinical prognosis of AP patients through a randomized controlled trial, in order to provide a scientific basis for the application of BL in the treatment of AP and to further explore its potential clinical value.
Objective: The purpose of this clinical trial is to investigate the impact of BL on the clinical prognosis of patients with AP, to analyze the correlation between BL and intestinal barrier function, as well as the gut microbiota, and to observe adverse reactions and risks in patients with AP after the use of BL.
Study design: Single-center, randomized, double-blind, placebo-controlled study.
Study population:60 adult patients with acute pancreatitis. Intervention: The intervention group receives standard clinical treatment plus BL capsules (10^10 CFU), twice a day, for a total of 14 days; the control group receives standard clinical treatment plus placebo capsules, for a total of 14 days.
Main study parameters/endpoints: The primary endpoint is the number of days without SIRS within 14 days; the secondary endpoints include infectious complications (including fungal infections), parameters related to systemic inflammatory response, intestinal barrier function and gut microbiota composition, indicators related to recovery of intestinal function, antibiotic use, laboratory-related indicators, and clinical outcomes.
Safety: Throughout the study (or afterwards), treatment-emergent adverse events (TEAEs) were recorded, including gastrointestinal adverse reactions (abdominal pain, nausea, vomiting, bloating, or diarrhea) and allergic reactions, and adverse events that led to discontinuation of the study drug were documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Bifidobacterium longum, Combination Product: Standard clinical treatmentBifidobacterium longum capsules (10^10 CFU) twice daily for 14 days |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo, Combination Product: Standard clinical treatmentPlacebo capsules twice daily for 14 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-75 year;
- The diagnosis of acute pancreatitis according to the revised Atlanta classification;
- The onset time of acute pancreatitis is within 48 hours;
- APACHE II score of ≥8, or C-reactive protein \> 150 mg/L, or SIRS score of ≥3;
- Signed the informed consent.
Key exclusion criteria (9 listed)
- Within 48 hours of onset, there is multi-organ failure;
- Use of probiotics within the last month;
- Pancreatitis following endoscopic retrograde cholangiopancreatography (ERCP);
- Intra-operative diagnosis;
- Infection/sepsis caused by a second disease;
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 longumBifidobacterium longum | Dietary supplement | Intervention group |
| PlaceboPlacebo | Dietary supplement | Placebo group |
| Standard clinical treatmentFasting, gastrointestinal decompression, rehydration, inhibition of pancreatic fluid and pancreatic enzyme secretion, improvement of microcirculation, and support of organ function if organ dysfunction occurs at a later stage (mechanical ventilation, continuous renal replacement therapy, and the use of vasoactive drugs). | Combination product | Intervention group, Placebo group |
Primary outcome
The number of days without SIRS within 14 days
Time frame: From randomization to 14 days after treatment
Patients were randomized into the study group and remained free of SIRS up to 14 days after enrollment, with the total number of SIRS-free days counted
16 secondary outcomes
Infectious complications
Time frame: During the whole study period including follow-up of 90 days
Intestinal barrier function
Time frame: Through study completion, an average of 1 year
Intestinal barrier function
Time frame: Through study completion, an average of 1 year
Intestinal barrier function
Time frame: Through study completion, an average of 1 year
Gut microbiota composition
Time frame: Baseline , 3 days，7 days and 14 days of treatment
Systemic inflammatory response parameters (SIRS)
Time frame: Through study completion, an average of 1 year
Systemic inflammatory response parameters (SIRS)
Time frame: Through study completion, an average of 1 year
Systemic inflammatory response parameters (SIRS)
Time frame: Through study completion, an average of 1 year
Gut function recovery-related indicators
Time frame: Through study completion, an average of 1 year
Antibiotic usage
Time frame: Through study completion, an average of 1 year
Mortality
Time frame: During the whole study period including follow-up of 90 days
(New onset) transient/persistant (multiple) organ failure
Time frame: During the whole study period including follow-up of 90 days
Disease severity according to the revised Atlanta Classification
Time frame: During the whole study period including follow-up of 90 days
Length of hospital and/or ICU stay
Time frame: Through study completion, an average of 1 year
The need (and number of) for surgical, endoscopic or radiologic interventions
Time frame: During the whole study period including follow-up of 90 days
Readmissions
Time frame: During the whole study period including follow-up of 90 days
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 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Cong He, PhD principal investigator
The First Affiliated Hospital of Nanchang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bifidobacterium longum and Standard clinical treatment in people with Acute Pancreatitis, run by The First Affiliated Hospital of Nanchang University 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 5 inclusion and 9 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: opening soon, as of the sponsor's last update on 6 Feb 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 yin zhu, PhD (+8613970847464, ndyfy01977@ncu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of days without SIRS within 14 days (time frame: From randomization to 14 days after treatment). 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 Feb 2025.