Beta-glucan on Fecal Microflora in Polypectomized Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Harokopio University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
JOTIS S.A. FOOD INDUSTRY, GREECE
Information provided by:
Harokopio University
ClinicalTrials.gov Identifier:
NCT00893659
First received: May 5, 2009
Last updated: September 2, 2009
Last verified: September 2009
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Beta-glucan on Faecal Microflora in Polypectomized Patients

Resource links provided by NLM:


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 Study Completion Date: January 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: wheat bread with beta-glucan supplementation Dietary Supplement: wheat bread with beta-glucan
3 g beta-glucan in approximately 200 g of wheat bread per day for 3 months
Placebo Comparator: wheat bread without beta-glucan Dietary Supplement: wheat bread without beta-glucan
Approximately 200 g of wheat bread (without beta-glucan supplementation) 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
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
ClinicalTrials.gov Identifier: NCT00893659     History of Changes
Other Study ID Numbers: HAR-GLUCAN-1
Study First Received: May 5, 2009
Last Updated: September 2, 2009
Health Authority: Greece: Ethics Committee

Keywords provided by Harokopio University:
Beta-glucan
faecal microflora
polypectomy
Precancerous Nonmalignant Condition

Additional relevant MeSH terms:
Adenomatous Polyps
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014