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SNE1725: Can Oral Glutamine Facilitate Early Return of Gut Function

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Scarborough General Hospital
Sponsor:
Information provided by (Responsible Party):
Syed Irfan Kabir, Scarborough General Hospital
ClinicalTrials.gov Identifier:
NCT01750138
First received: December 11, 2012
Last updated: December 12, 2012
Last verified: December 2012
  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.

Resource links provided by NLM:


Further study details as provided by Scarborough General Hospital:

Primary Outcome Measures:
  • 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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01750138

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         
Sponsors and Collaborators
Scarborough General Hospital
Investigators
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 November 25, 2014