SNE1725: Can Oral Glutamine Facilitate Early Return of Gut Function

NCT01750138 | Unknown DMC

• 1 other identifier: SNE1725
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

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.

Conditions

Gut Function

Outcome Measures

Primary Outcomes (1)

• Gut function

  post op

Study Arms (2)

Glutamine

EXPERIMENTAL

Glutamine powder given preoperatively for five days

Drug: Glutamine

Placebo

ACTIVE COMPARATOR

dextrose powder for 5 days pre-operatively

Drug: Dextrose powder

Interventions

Glutamine DRUG

Glutamine

Dextrose powder DRUG

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients undergoing elective colorectal surgery (both open or keyhole) will be eligible for the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Scarborough General Hospital: lead

Study Sites (1)

Scarborough District Hospital

Scarborough, North Yorkshire, YO12 6QL, United Kingdom

RECRUITING

MeSH Terms

Interventions

Glutamine

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral

Study Officials

• syed irfan kabir, MBBS, MSc

  Scarborough General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: December 11, 2012
• First Posted: December 17, 2012
• Study Start: June 1, 2011
• Primary Completion: June 1, 2014
• Last Updated: December 17, 2012

Record last verified: 2012-12

Locations

GB (1)