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The Effect of Beta-glucan on Faecal Microflora in Polypectomized Patients


N/A
20 Years
75 Years
Open (Enrolling)
Both
Polypectomy, Adenomatous Polyps

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Trial Information

The Effect of Beta-glucan on Faecal Microflora in Polypectomized Patients


Prebiotics, such as short- and long-chain fructo-oligosaccharides are fermented by the
microflora colonizing the gastrointestinal tract, and they selectively stimulate the growth
or the activity of one or limited number of bacteria within the intestine. Beta-glucans are
polysaccharides occurring in the bran of cereal grains, the cell wall of Saccharomyces
cerevisiae and bacteria, certain types of fungi, seaweed and many kinds of mushrooms. The
aim of this study is to determine the effect of the potential prebiotic beta-glucan on the
intestinal microflora, the bacterial enzyme activity (beta-glucuronidase and
beta-glucosidase) in the faeces, the faecal pH, and the concentration of faecal short-chain
fatty acid in polypectomized patients.


Inclusion Criteria:



- The subjects must have biopsy and histologically confirmed adenomatous polyps ≥ 1cm
in size or ≥ 3 in number with moderate or severe dysplasia

Exclusion Criteria:

- Subjects ≥ 75 years of age

- Subjects who are pregnant or desire to become pregnant during the study period

- Subjects who are considered to be poor clinic attendees

- Subjects who have been on antibiotics within the previous month or are likely to
require antibiotics during the trial

- Subjects who consume prebiotics or probiotics within the previous month or are likely
to require antibiotics during the trial

- Subjects with colon cancer

- Subjects with additional gastrointestinal disorders (e.g., Crohn's disease or
ulcerative colitis)

- Subjects with malignancy or any end-stage organ disease

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To measure the effect of beta-glucan on fecal microflora (number of bacteria, bacterial enzyme activity, SCFA, pH).

Outcome Time Frame:

four months

Safety Issue:

No

Principal Investigator

Adamantini Kyriacou, Ass. Professor

Investigator Role:

Study Director

Investigator Affiliation:

Harokopio University

Authority:

Greece: Ethics Committee

Study ID:

HAR-GLUCAN-1

NCT ID:

NCT00893659

Start Date:

January 2009

Completion Date:

January 2011

Related Keywords:

  • Polypectomy
  • Adenomatous Polyps
  • Beta-glucan
  • faecal microflora
  • polypectomy
  • Precancerous Nonmalignant Condition
  • Adenomatous Polyps

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