Efficacy of Enteral Glutamine Supplementation in Patients With Predicted Severe Acute Pancreatitis- A Double-Blinded Randomized Controlled Trial
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|ClinicalTrials.gov Identifier: NCT01503320|
Recruitment Status : Completed
First Posted : January 4, 2012
Last Update Posted : June 8, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Pancreatitis||Dietary Supplement: Enteral glutamine Dietary Supplement: Placebo||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||December 2014|
|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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01503320
|Asian Institute of Gastroenterology|
|Hyderabad, Andhra Pradesh, India, 500082|
|Principal Investigator:||Rupjyoti Talukdar, MD||Asian Institute of Gastroenterology|