Beta-glucan on Fecal Microflora in Polypectomized Patients

Not Applicable

Completed

• Conditions: Polypectomized Patients
• Interventions: Dietary Supplement: wheat bread without beta-glucan; Dietary Supplement: wheat bread with beta-glucan

• Registration Number: NCT00893659
• Lead Sponsor: Harokopio University

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-05-05
• Study First Submitted QC: 2009-05-05
• Study First Posted: 2009-05-06
• Primary Completion: 2012-12
• Status Verified: 2015-07
• Study Completion: 2015-07
• Last Update Submitted: 2015-07-23
• Last Update Posted: 2015-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
wheat bread without beta-glucan	wheat bread without beta-glucan	-
wheat bread with beta-glucan supplementation	wheat bread with beta-glucan	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To study the fecal water cyto- and/or genotoxicity on HT-29 cell line.	one year

Trial Locations

Locations (1)

Harokopio University; 🇬🇷 Athens, Attica, Greece