SNE1725: Can Oral Glutamine Facilitate Early Return of Gut Function

December 12, 2012 updated by: Syed Irfan Kabir, Scarborough General Hospital

Can Preoperative Oral Glutamine Facilitate Earlier Return of Gut Function in Patients Undergoing Colorectal Surgery. A Prospective Randomized Trial.

The gastrointestinal tract has many functions; it provides nutrition, produces hormones, performs a barrier function, maintains a stable gastrointestinal micro flora and plays an important role in the inflammatory process as it is the largest producer of cytokines (proteins associated with inflammation). This gut function is impaired after colorectal (bowel) surgery. There is evidence to suggest that impaired gut function is associated with increased complications. Hence if gut function is preserved, it should equate with better outcomes. As a result, there has been increasing interest in treatments called Gut Specific Nutrients (GSN), which specifically target gut function. Most notable of them is Glutamine, a conditionally essential amino acid and preferred fuel source for intestinal cells. Research has shown that glutamine promotes cell growth, increases clearance of harmful organisms from the blood, and reduces the surgical stress response. In other words, glutamine has a favourable influence on gut function.

Recent studies from our unit using intravenous glutamine in critically ill patients have shown an early return of gut function, which in turn is associated with attenuation of the inflammatory response and improved outcomes. It is not known whether oral glutamine is associated with a similar outcome. A recent pilot study at our unit suggests an association between oral glutamine and early return of gut function. The aim of this research is to determine if giving oral glutamine results in an early return of gut function and whether this is associated with an attenuation of the systemic inflammatory response.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

206

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • North Yorkshire
      • Scarborough, North Yorkshire, United Kingdom, YO12 6QL
        • Recruiting
        • Scarborough District Hospital
        • Contact:
        • Principal Investigator:
          • irfan kabir, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All adult patients undergoing elective colorectal surgery (both open or keyhole) will be eligible for the study.

Exclusion Criteria:

  • Allergy to glutamine/placebo
  • Failure to obtain informed consent.
  • Patients with existing infections.
  • Pregnant women and children under the age of 18 years will be excluded from the study.
  • Patients on antibiotics in the previous 2 weeks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Glutamine
Glutamine powder given preoperatively for five days
Drug: Glutamine
ACTIVE_COMPARATOR: Placebo
dextrose powder for 5 days pre-operatively
Drug: Dextrose powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Gut function
Time Frame: post op
post op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scarborough General Hospital

Investigators

  • Principal Investigator: syed irfan kabir, MBBS, MSc, Scarborough General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ANTICIPATED)

June 1, 2014

Study Registration Dates

First Submitted

December 11, 2012

First Submitted That Met QC Criteria

December 12, 2012

First Posted (ESTIMATE)

December 17, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 17, 2012

Last Update Submitted That Met QC Criteria

December 12, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • SNE1725

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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