Effect of prebiotic and probiotic drink in reducing the serious septic complications of severe pancreatitis
Phase 3
Completed
- Conditions
- Health Condition 1: K859- Acute pancreatitis, unspecifiedHealth Condition 2: null- All patients of more than 18 years of age admitted with a diagnosis of acute pancreatitis in the department of general surgery will be included
- Registration Number
- CTRI/2018/03/012597
- Lead Sponsor
- JIPMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 86
Inclusion Criteria
All patients >18 years undergoing treatment for moderately severe and severe acute pancreatitis
Exclusion Criteria
1.Traumatic pancreatitis
2.Pancreatitis after endoscopic retrograde cholangio-pancreaticography (ERCP)
3.Suspected/ Proven malignancy of the pancreas or biliary tree
4.Non-pancreatic infection or sepsis caused by a second disease
5.Diagnosis of pancreatitis first made at operation
6.Medical history of immune deficiency
7.Acute- on chronic pancreatitis
8.Pancreatitis patients presents with evidence of sepsis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Septic complications such as Infected pancreatic necrosis <br/ ><br>Pancreatic abscess <br/ ><br>Bacteremia <br/ ><br>Pneumonia or Urosepsis <br/ ><br>Infected ascites <br/ ><br>Reduction in markers one day before the synbiotic supplementation and after 7 days and 14 days of probiotics therapy <br/ ><br>TLC DLC <br/ ><br>IL8 IL10 TNF alpha <br/ ><br>LDH CRP <br/ ><br>Timepoint: Septic complications defined as the following occurs during hospital stay or within 90 days follow up <br/ ><br>Reduction in the systemic inflammatory response by measuring the following inflammatory markers one day before the synbiotic supplementation and after 7 days and 14 days of probiotics therapy
- Secondary Outcome Measures
Name Time Method Mortality <br/ ><br>Morbidity related to organ dysfunction <br/ ><br>Sequential organ failure assessment scores <br/ ><br>Onset of multi organ failure after randomization and during admission <br/ ><br>Non-septic morbidity <br/ ><br>Abdominal complaints like Vomiting diarrhea intolerance to enteral feeding <br/ ><br>Length of hospital stay and ICU stay in days <br/ ><br>Requirement of surgical and minimally invasive procedure <br/ ><br>Timepoint: 90 days