SNE1725: Can Oral Glutamine Facilitate Early Return of Gut Function
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|ClinicalTrials.gov 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
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|
|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|
Glutamine powder given preoperatively for five days
Active Comparator: Placebo
dextrose powder for 5 days pre-operatively
|Drug: Dextrose powder|
- Gut function [ Time Frame: post op ]
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): NCT01750138
|Scarborough District Hospital||Recruiting|
|Scarborough, North Yorkshire, United Kingdom, YO12 6QL|
|Contact: Irfan Kabir, MBBS 00-44-1723368111 ext 5123 email@example.com|
|Principal Investigator: irfan kabir, MBBS|
|Principal Investigator:||syed irfan kabir, MBBS, MSc||Scarborough General Hospital|