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Beta-glucan on Fecal Microflora in Polypectomized Patients

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ClinicalTrials.gov Identifier: NCT00893659
Recruitment Status : Completed
First Posted : May 6, 2009
Last Update Posted : July 24, 2015
Sponsor:
Collaborator:
JOTIS S.A. FOOD INDUSTRY, GREECE
Information provided by (Responsible Party):
Kyriacou Adamantini, 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.

Condition or disease Intervention/treatment
Polypectomized Patients Dietary Supplement: wheat bread with beta-glucan Dietary Supplement: wheat bread without beta-glucan

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Beta-glucan on Faecal Microflora in Polypectomized Patients
Study Start Date : January 2009
Primary Completion Date : December 2012
Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. To measure the effect of beta-glucan on fecal microflora (number of bacteria, bacterial enzyme activity, SCFA, pH). [ Time Frame: four months ]
  2. To observe the effect of beta-glucan on intestinal symptoms and well-being. [ Time Frame: four months ]

Secondary Outcome Measures :
  1. To study the fecal water cyto- and/or genotoxicity on HT-29 cell line. [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00893659


Locations
Greece
Harokopio University
Athens, Attica, Greece, 17671
Sponsors and Collaborators
Harokopio University
JOTIS S.A. FOOD INDUSTRY, GREECE
Investigators
Study Director: Adamantini Kyriacou, Ass. Professor Harokopio University

Responsible Party: Kyriacou Adamantini, Assistant Professor, Harokopio University
ClinicalTrials.gov Identifier: NCT00893659     History of Changes
Other Study ID Numbers: HAR-GLUCAN-1
First Posted: May 6, 2009    Key Record Dates
Last Update Posted: July 24, 2015
Last Verified: July 2015

Keywords provided by Kyriacou Adamantini, Harokopio University:
Beta-glucan
faecal microflora
polypectomized
Precancerous Nonmalignant Condition