SNE1725: Can Oral Glutamine Facilitate Early Return of Gut Function

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. Identifier: NCT01750138
Recruitment Status : Unknown
Verified December 2012 by Syed Irfan Kabir, Scarborough General Hospital.
Recruitment status was:  Recruiting
First Posted : December 17, 2012
Last Update Posted : December 17, 2012
Information provided by (Responsible Party):
Syed Irfan Kabir, Scarborough General Hospital

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Gut Function Drug: Glutamine Drug: Dextrose powder Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Can Preoperative Oral Glutamine Facilitate Earlier Return of Gut Function in Patients Undergoing Colorectal Surgery. A Prospective Randomized Trial.
Study Start Date : June 2011
Estimated Primary Completion Date : June 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Glutamine
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Gut function [ Time Frame: post op ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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 identifier (NCT number): NCT01750138

United Kingdom
Scarborough District Hospital Recruiting
Scarborough, North Yorkshire, United Kingdom, YO12 6QL
Contact: Irfan Kabir, MBBS    00-44-1723368111 ext 5123   
Principal Investigator: irfan kabir, MBBS         
Sponsors and Collaborators
Scarborough General Hospital
Principal Investigator: syed irfan kabir, MBBS, MSc Scarborough General Hospital

Responsible Party: Syed Irfan Kabir, Research Fellow, Scarborough General Hospital Identifier: NCT01750138     History of Changes
Other Study ID Numbers: SNE1725
First Posted: December 17, 2012    Key Record Dates
Last Update Posted: December 17, 2012
Last Verified: December 2012