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SNE1725: Can Oral Glutamine Facilitate Early Return of Gut Function

NCT ID: NCT01750138

Last Updated: 2012-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Brief Summary

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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

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Conditions

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Gut Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Glutamine

Glutamine powder given preoperatively for five days

Group Type EXPERIMENTAL

Glutamine

Intervention Type DRUG

Placebo

dextrose powder for 5 days pre-operatively

Group Type ACTIVE_COMPARATOR

Dextrose powder

Intervention Type DRUG

Interventions

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Glutamine

Intervention Type DRUG

Dextrose powder

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Scarborough General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Syed Irfan Kabir

Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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syed irfan kabir, MBBS, MSc

Role: PRINCIPAL_INVESTIGATOR

Scarborough General Hospital

Locations

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Scarborough District Hospital

Scarborough, North Yorkshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Facility Contacts

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Irfan Kabir, MBBS

Role: primary

Other Identifiers

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SNE1725

Identifier Type: -

Identifier Source: org_study_id