SNE1725: Can Oral Glutamine Facilitate Early Return of Gut Function

Study Overview
=================
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.

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

Conditions
-----------------
Gut Function

Intervention / Treatment
-----------------
* Drug: Glutamine
* Drug: Dextrose powder


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glutamine<br>Glutamine powder given preoperatively for five days | Drug: Glutamine<br> <br> |
| Active Comparator: Placebo<br>dextrose powder for 5 days pre-operatively | Drug: Dextrose powder<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut function |  | post op |