Efficacy of Enteral Glutamine Supplementation in Patients With Predicted Severe Acute Pancreatitis- A Double-Blinded Randomized Controlled Trial
Acute pancreatitis (AP) is a potentially serious illness characterized by inflammation of the pancreas with variable involvement of peri-pancreatic tissues and/ or remote organ systems. AP is hyper catabolic condition due to systemic inflammatory response syndrome (SIRS without any proven specific treatments. Therefore, current therapy for AP is directed to intensive medical care, nutrition support and infection control.
Nutritional support is very crucial in the treatment of AP. Enteral nutrition (EN) is the preferred modality since parenteral nutrition is associated with various complications. EN could preserve the intestinal permeability, which would be the best barrier for prevention of certain complications.
Glutamine is the most abundant free amino acid in the body and is used as a major fuel and nucleotide substrate. When a nutritional deficiency arises in critical illness including SAP, glutamine tends to be conditionally depleted.
We hypothesize that enteral glutamine supplementation in patients with severe and predicted severe acute pancreatitis helps in their early recovery and prevention of adverse outcomes.
In this study, we aim to evaluate the therapeutic effect of enteral glutamine on clinical outcomes, gut permeability, systemic inflammation, oxidative stress and plasma glutamine levels.
|Acute Pancreatitis||Dietary Supplement: Enteral glutamine Dietary Supplement: Placebo|
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
- Development of infected (peri)pancreatic necrosis [ Time Frame: Baseline; 7 days; 6 months ]
- Mortality [ Time Frame: Baseline; 7 days; 6 months ]
- Change in levels of HS- CRP. [ Time Frame: Baseline, 7 days, 14 days ]
- Change in mucosal permeability [ Time Frame: Baseline, 7 days, 14 days ]
- Change in level of oxidative stress [ Time Frame: Baseline, 7 days, 14 days ]
- Change in cytokine levels in serum [ Time Frame: Baseline, 7 days, 14 days ]
|Study Start Date:||January 2012|
|Study Completion Date:||December 2014|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
|Experimental: Enteral glutamine||
Dietary Supplement: Enteral glutamine
Dosage of glutamine: 0.57g/kg, ~ 30g/day= 3sachets
|Placebo Comparator: Placebo||
Dietary Supplement: Placebo
Similar appearing nutritional supplement without glutamine.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01503320
|Asian Institute of Gastroenterology|
|Hyderabad, Andhra Pradesh, India, 500082|
|Principal Investigator:||Rupjyoti Talukdar, MD||Asian Institute of Gastroenterology|