SNE1725: Can Oral Glutamine Facilitate Early Return of Gut Function

Not Applicable

• Conditions: Gut Function
• Interventions: Drug: Dextrose powder; Drug: Glutamine

• Registration Number: NCT01750138
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Status Verified: 2012-12
• Study First Submitted: 2012-12-11
• Study First Submitted QC: 2012-12-12
• Last Update Submitted: 2012-12-12
• Study First Posted: 2012-12-17
• Last Update Posted: 2012-12-17
• Primary Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 206

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Dextrose powder	dextrose powder for 5 days pre-operatively
Glutamine	Glutamine	Glutamine powder given preoperatively for five days

Primary Outcome Measures

Name	Time	Method
Gut function	post op

Trial Locations

Locations (1)

Scarborough District Hospital; 🇬🇧 Scarborough, North Yorkshire, United Kingdom