Clinical trial NCT00893659: Beta-glucan on Fecal Microflora in Polypectomized Patients
Official title: The Effect of Beta-glucan on Faecal Microflora in Polypectomized Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polypectomized Patients
Keywords: Beta-glucan
faecal microflora
polypectomized
Precancerous Nonmalignant Condition
Lead sponsor: Harokopio University
Sponsor class: OTHER
Collaborators: name: JOTIS S.A. FOOD INDUSTRY, GREECE
First posted: 2009-05-06
Enrollment: 69
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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 feces, the fecal pH and the concentration of fecal short-chain fatty acid in polypectomized patients. Also the in vitro anti-cyto- and anti-genotoxicity of fecal water will be examined on human cell culture (HT29). During the trial, patient's clinical symptoms (intestinal habits), physical activity, well-being and food intake will be recorded.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: To measure the effect of beta-glucan on fecal microflora (number of bacteria, bacterial enzyme activity, SCFA, pH).
timeFrame: four months
measure: To observe the effect of beta-glucan on intestinal symptoms and well-being.
timeFrame: four months
Secondary outcomes:
measure: To study the fecal water cyto- and/or genotoxicity on HT-29 cell line.
timeFrame: one year
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Harokopio University
state: Attica
Study officials:
affiliation: Harokopio University
name: Adamantini Kyriacou, Ass. Professor
role: STUDY_DIRECTOR
References: