Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

May 5, 2009
September 2, 2009
January 2009
January 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00893659 on ClinicalTrials.gov Archive Site
To study the fecal water cyto- and/or genotoxicity on HT-29 cell line. [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Beta-glucan on Fecal Microflora in Polypectomized Patients
The Effect of Beta-glucan on Faecal Microflora in Polypectomized Patients

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Polypectomy
  • Adenomatous Polyps
  • Dietary Supplement: wheat bread with beta-glucan
    3 g beta-glucan in approximately 200 g of wheat bread per day for 3 months
  • Dietary Supplement: wheat bread without beta-glucan
    Approximately 200 g of wheat bread (without beta-glucan supplementation) per day for 3 months
  • Experimental: wheat bread with beta-glucan supplementation
    Intervention: Dietary Supplement: wheat bread with beta-glucan
  • Placebo Comparator: wheat bread without beta-glucan
    Intervention: Dietary Supplement: wheat bread without beta-glucan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact: Adamantini Kyriacou, Ass. Professor +302109549142 mkyriacou@hua.gr
Contact: Katja Turunen, Cl. Nutrionist +302109549135 k.t.turunen@gmail.com
Greece
 
NCT00893659
HAR-GLUCAN-1
Yes
Harokopio University
Harokopio University
JOTIS S.A. FOOD INDUSTRY, GREECE
Study Director: Adamantini Kyriacou, Ass. Professor Harokopio University
Harokopio University
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP