Beta-glucan on Fecal Microflora in Polypectomized Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Polypectomized Patients

Intervention / Treatment
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* Dietary Supplement: wheat bread with beta-glucan
* Dietary Supplement: wheat bread without beta-glucan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: wheat bread with beta-glucan supplementation<br> | Dietary Supplement: wheat bread with beta-glucan<br>* 3 g beta-glucan in approximately 200 g of wheat bread per day for 3 months<br>|
| Placebo Comparator: wheat bread without beta-glucan<br> | Dietary Supplement: wheat bread without beta-glucan<br>* Approximately 200 g of wheat bread (without beta-glucan supplementation) per day for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the effect of beta-glucan on fecal microflora (number of bacteria, bacterial enzyme activity, SCFA, pH). |  | four months | 
| To observe the effect of beta-glucan on intestinal symptoms and well-being. |  | four months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study the fecal water cyto- and/or genotoxicity on HT-29 cell line. |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Beta-glucan, faecal microflora, polypectomized, Precancerous Nonmalignant Condition