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Efficacy of Enteral Glutamine Supplementation in Patients With Predicted Severe Acute Pancreatitis- A Double-Blinded Randomized Controlled Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01503320
First Posted: January 4, 2012
Last Update Posted: June 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Asian Institute of Gastroenterology, India
  Purpose

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 Intervention
Acute Pancreatitis Dietary Supplement: Enteral glutamine Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Asian Institute of Gastroenterology, India:

Primary Outcome Measures:
  • Development of infected (peri)pancreatic necrosis [ Time Frame: Baseline; 7 days; 6 months ]
  • Mortality [ Time Frame: Baseline; 7 days; 6 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: January 2012
Study Completion Date: December 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients over the age 18.
  • Patient admitted within 72hrs of onset of abdominal pain for over 24hr with raised (>3- fold) serum lipase/amylase on admission.
  • Marshall Score of ≥ 2 in any one organ, excluding the liver component
  • Pancreatic necrosis >30% on Computed tomography (CT) scan or a modified CT severity index of ≥6.
  • Apache II score ≥8.
  • BUN at admission of >20mg/dL or an BUN elevation of >5mg/dL within 48hrs of admission.

Exclusion Criteria:

  • Patients with chronic pancreatitis and pancreatic insufficiency requiring pancreatic enzyme supplements.
  • Pre-existing chronic renal insufficiency requiring hemodialysis or peritoneal dialysis.
  • Patients with ARF.
  • Pre-existing end-stage liver disease with ascites, coagulopathy and encephalopathy.
  • Pancreatic cancer.
  • Current somatostatin or corticosteroid therapy.
  • Any form of artificial feeding since commencement of acute pancreatitis symptoms.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
India
Asian Institute of Gastroenterology
Hyderabad, Andhra Pradesh, India, 500082
Sponsors and Collaborators
Asian Institute of Gastroenterology, India
Investigators
Principal Investigator: Rupjyoti Talukdar, MD Asian Institute of Gastroenterology
  More Information

Responsible Party: Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier: NCT01503320     History of Changes
Other Study ID Numbers: AIG-GI-2011-05
First Submitted: January 1, 2012
First Posted: January 4, 2012
Last Update Posted: June 8, 2015
Last Verified: June 2015

Keywords provided by Asian Institute of Gastroenterology, India:
To evaluate
efficacy
enteral glutamine

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases


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