SNE1725: Can Oral Glutamine Facilitate Early Return of Gut Function
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Purpose
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 | Intervention |
|---|---|
|
Gut Function |
Drug: Glutamine Drug: Dextrose powder |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) |
| Official Title: | Can Preoperative Oral Glutamine Facilitate Earlier Return of Gut Function in Patients Undergoing Colorectal Surgery. A Prospective Randomized Trial. |
- Gut function [ Time Frame: post op ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 206 |
| Study Start Date: | June 2011 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Glutamine
Glutamine powder given preoperatively for five days
|
Drug: Glutamine |
|
Active Comparator: Placebo
dextrose powder for 5 days pre-operatively
|
Drug: Dextrose powder |
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| United Kingdom | |
| Scarborough District Hospital | Recruiting |
| Scarborough, North Yorkshire, United Kingdom, YO12 6QL | |
| Contact: Irfan Kabir, MBBS 00-44-1723368111 ext 5123 irfankabir@hotmail.com | |
| Principal Investigator: irfan kabir, MBBS | |
| Principal Investigator: | syed irfan kabir, MBBS, MSc | Scarborough General Hospital |
More Information
No publications provided
| Responsible Party: | Syed Irfan Kabir, Research Fellow, Scarborough General Hospital |
| ClinicalTrials.gov Identifier: | NCT01750138 History of Changes |
| Other Study ID Numbers: | SNE1725 |
| Study First Received: | December 11, 2012 |
| Last Updated: | December 12, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee |
ClinicalTrials.gov processed this record on May 21, 2013