Effect of prebiotic and probiotic drink in reducing the serious septic complications of severe pancreatitis

Effect of synbiotics in reducing the systemic inflammatory response and septic complications in moderately severe and severe acute pancreatitis- A prospective parallel arm double blind randomised trial.

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/03/012597

Enrollment

Registered

2018-03-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K859- Acute pancreatitis, unspecified Health 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

Interventions

Intervention1: synbiotic powder: synbiotic powder (two sachets) mixed in saline twice a day through nasogastric tube starting at the earliest and not later than 72 hours. The same preparation will be

Eligibility

Inclusion criteria

Inclusion criteria: All patients >18 years undergoing treatment for moderately severe and severe acute pancreatitis

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Septic complications such as Infected pancreatic necrosis Pancreatic abscess Bacteremia Pneumonia or Urosepsis Infected ascites Reduction in markers one day before the synbiotic supplementation and after 7 days and 14 days of probiotics therapy TLC DLC IL8 IL10 TNF alpha LDH CRP Timepoint: Septic complications defined as the following occurs during hospital stay or within 90 days follow up 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	—

Measure

Time frame

Septic complications such as Infected pancreatic necrosis Pancreatic abscess Bacteremia Pneumonia or Urosepsis Infected ascites Reduction in markers one day before the synbiotic supplementation and after 7 days and 14 days of probiotics therapy TLC DLC IL8 IL10 TNF alpha LDH CRP Timepoint: Septic complications defined as the following occurs during hospital stay or within 90 days follow up 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

Measure	Time frame
Mortality Morbidity related to organ dysfunction Sequential organ failure assessment scores Onset of multi organ failure after randomization and during admission Non-septic morbidity Abdominal complaints like Vomiting diarrhea intolerance to enteral feeding Length of hospital stay and ICU stay in days Requirement of surgical and minimally invasive procedure Timepoint: 90 days	—

Countries

India

Contacts

Public ContactG Rohith

Jawaharlal Institute of Postgraduate Medical Education and Research

drsureshkumar08@yahoo.com9788637893

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 14, 2026