SNE1725: Can Oral Glutamine Facilitate Early Return of Gut Function

Gut Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01750138
• Other study ID #: SNE1725
• Status: Recruiting
• Phase: N/A
• First received: December 11, 2012
• Last updated: December 12, 2012
• Start date: June 2011

Study information

• Verified date: December 2012
• Source: Scarborough General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 206
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Gut Function

Intervention

Drug:
• Glutamine

• Dextrose powder

Locations

Country	Name	City	State
United Kingdom	Scarborough District Hospital	Scarborough	North Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Scarborough General Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut function		post op	No