Beta-Glucan on Fecal Microflora in Polypectomized Patients - Full Text View

Sponsors and Collaborators:	Harokopio University JOTIS S.A. FOOD INDUSTRY, GREECE
Information provided by:	Harokopio University
ClinicalTrials.gov Identifier:	NCT00893659

Purpose

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.

Condition	Intervention
Polypectomy Adenomatous Polyps	Dietary Supplement: wheat bread with beta-glucan Dietary Supplement: wheat bread without beta-glucan

MedlinePlus related topics: Dietary Supplements Diets Drinking Water

Drug Information available for: beta-Glucan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Effect of Beta-Glucan on Faecal Microflora in Polypectomized Patients

Further study details as provided by Harokopio University:

Primary Outcome Measures:

To measure the effect of beta-glucan on fecal microflora (number of bacteria, bacterial enzyme activity, SCFA, pH). [ Time Frame: four months ] [ Designated as safety issue: No ]
To observe the effect of beta-glucan on intestinal symptoms and well-being. [ Time Frame: four months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To study the fecal water cyto- and/or genotoxicity on HT-29 cell line. [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	January 2009
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
wheat bread with beta-glucan supplementation: Experimental	Dietary Supplement: wheat bread with beta-glucan 3 g per day for 3 months
wheat bread without beta-glucan: Placebo Comparator	Dietary Supplement: wheat bread without beta-glucan 3 g per day for 3 months

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

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893659

Contacts

Contact: Adamantini Kyriacou, Ass. Professor	+302109549142	mkyriacou@hua.gr
Contact: Katja Turunen, CL Nutrionist	+302109549135	k.t.turunen@gmail.com

Locations

Greece, Attica
Harokopio University	Recruiting
Athens, Attica, Greece, 17671
Contact: Adamantini Kyriacou, Assoc. Professor +302109549142 mkyriacou@hua.gr

Sponsors and Collaborators

Harokopio University

JOTIS S.A. FOOD INDUSTRY, GREECE

Investigators

Study Director:

Adamantini Kyriacou, Ass. Professor

Harokopio University

More Information

No publications provided

Responsible Party:	Harokopio University ( Harokopio University )
Study ID Numbers:	HAR-GLUCAN-1
Study First Received:	May 5, 2009
Last Updated:	May 5, 2009
ClinicalTrials.gov Identifier:	NCT00893659 History of Changes
Health Authority:	Greece: Ethics Committee

Keywords provided by Harokopio University:

Beta-glucan
faecal microflora
polypectomy
Precancerous Nonmalignant Condition

Study placed in the following topic categories:

Precancerous Conditions
Polyps
Adenoma
Adenomatous Polyps
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Adenoma
Adenomatous Polyps
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009