FindTrial
Sign In

A Double Blind Placebo Controlled Trial Assessing Rifaximins Effect on Infected Pancreatic Necrosis in Patients with Acute Necrotizing Pancreatitis.

A randomized double-blind placebo-controlled trial to evaluate the effect of Rifaximin to reduce the incidence of infected pancreatic Necrosis in patients with Acute necrotizing pancreatitis without persistent organ failure. - PAN-RIX

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089677
Enrollment
100
Registered
2025-06-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: K858- Other acute pancreatitis

Interventions

Intervention1: Oral Rifaximin Group: Patients will receive oral rifaximin at a dose of 550 mg 2 times daily for 6 weeks. Control Intervention1: Placebo Group: Patients will receive a matching placebo

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults (age 12-75 years) diagnosed with acute necrotizing pancreatitis without any persistent organ failure presenting beyond first week till 6 week of onset of illness.

Exclusion criteria

Exclusion criteria: 1. Persistent organ failure 2. evidence of infected pancreatic necrosis at time of screening 3. prior drainage and/or necrosectomy 4. contraindication to enteral feeding or not tolerating enteral feed 5. Major comorbidity such as decompensated cirrhosis, heart failure, significant lung parenchymal or airway disease, advanced chronic kidney disease 6. pregnancy 7. patients with chronic pancreatitis 8. refusal to give consent

Design outcomes

Primary

MeasureTime frame
Incidence of Infected (peri) pancreatic fluid collections.Timepoint: From randomization to 90 days.—

Secondary

MeasureTime frame
Need for drainage of collection (endoscopic, percutaneous or surgical) Need for necrosectomy Hospital readmission rate within 42 days of discharge Mortality rate at 90 days Length of hospital stay (days) Need for antibiotics for suspected infected pancreatic fluid collections Duration of antibiotic use Incidence of new-onset organ failure Duration of Organ failure Time to readmission after discharge adverse events associated with rifaximin administration Duration of ICU stay 60 days alive and out of hospital (DAOH60) post discharge Change in gut microbiome at baseline and at day 42 Improvement in BMI, Albumin, CRP, Faecal elastaseTimepoint: From randomization to 42 days, 60 days, and 90 days.—

Countries

India

Contacts

Public ContactDr Mohammad Tabish

All India Institute of Medical Sciences

soumyajagannath@yahoo.com9990420767

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026