Therapeutic Effect of Bifidobacterium Longum in Patients with Acute Pancreatitis: a Randomized, Double-Blind, Placebo-Controlled Trial

Launched by THE FIRST AFFILIATED HOSPITAL OF NANCHANG UNIVERSITY · Oct 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a specific probiotic called Bifidobacterium longum (BL) on patients with acute pancreatitis, a sudden inflammation of the pancreas. The goal is to see if taking BL along with standard medical treatments can improve recovery and support the gut's health. The researchers will also look for any side effects from taking the probiotic. In this trial, 60 patients aged 18 to 75 who have been diagnosed with acute pancreatitis within the last 48 hours may be eligible to participate.

Participants will be randomly placed into two groups: one will receive the standard treatment plus BL capsules taken twice daily for 14 days, while the other group will receive standard treatment plus placebo capsules that do not contain BL. This means that some patients will get the actual probiotic while others will receive a dummy version to compare the results. It’s important for potential participants to know that they cannot have certain conditions, such as multi-organ failure or recent use of probiotics, to qualify for this study. If you or a loved one fits the criteria, this trial could provide an opportunity to help improve understanding and treatment of acute pancreatitis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18-75 year;
• • 2. The diagnosis of acute pancreatitis according to the revised Atlanta classification;
• • 3. The onset time of acute pancreatitis is within 48 hours;
• • 4. APACHE II score of ≥8, or C-reactive protein \> 150 mg/L, or SIRS score of ≥3;
• • 5. Signed the informed consent.
• Exclusion Criteria:
• • 1. Within 48 hours of onset, there is multi-organ failure;
• • 2. Use of probiotics within the last month;
• • 3. Pancreatitis following endoscopic retrograde cholangiopancreatography (ERCP);
• • 4. Intra-operative diagnosis;
• • 5. Infection/sepsis caused by a second disease;
• • 6. Malignancy;
• • 7. Immunocompromised patients;
• • 8. Pregnancy and/or lactation;
• • 9. Allergy to Bifidobacterium longum.