Beta-glucan on Fecal Microflora in Polypectomized Patients

NCT ID: NCT00893659

Last Updated: 2015-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2015-07-31

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.

Conditions

Polypectomized Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

wheat bread with beta-glucan supplementation

Group Type: EXPERIMENTAL

wheat bread with beta-glucan

Intervention Type: DIETARY_SUPPLEMENT

3 g beta-glucan in approximately 200 g of wheat bread per day for 3 months

wheat bread without beta-glucan

Group Type: PLACEBO_COMPARATOR

wheat bread without beta-glucan

Intervention Type: DIETARY_SUPPLEMENT

Approximately 200 g of wheat bread (without beta-glucan supplementation) per day for 3 months

Interventions

wheat bread with beta-glucan

3 g beta-glucan in approximately 200 g of wheat bread per day for 3 months

Intervention Type: DIETARY_SUPPLEMENT

wheat bread without beta-glucan

Approximately 200 g of wheat bread (without beta-glucan supplementation) per day for 3 months

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

JOTIS S.A. FOOD INDUSTRY, GREECE

UNKNOWN

Sponsor Role: collaborator

Harokopio University

OTHER

Sponsor Role: lead

Responsible Party

Kyriacou Adamantini

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adamantini Kyriacou, Ass. Professor

Role: STUDY_DIRECTOR

Harokopio University

Locations

Harokopio University

Athens, Attica, Greece

Countries

Greece

Other Identifiers

HAR-GLUCAN-1

Identifier Type: -

Identifier Source: org_study_id