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Completed

NCT Number: NCT00893659

Beta-glucan on Fecal 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.

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harokopio University

Athens, Attica, 17671, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

wheat bread with beta-glucan

Dietary Supplement

3 g beta-glucan in approximately 200 g of wheat bread per day for 3 months

wheat bread without beta-glucan

Dietary Supplement

Approximately 200 g of wheat bread (without beta-glucan supplementation) per day for 3 months

Primary outcomes

  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 outcomes

  1. To study the fecal water cyto- and/or genotoxicity on HT-29 cell line.

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Harokopio University

Other

Collaborators

  • JOTIS S.A. FOOD INDUSTRY, GREECE

Registry information

Official study title

The Effect of Beta-glucan on Faecal Microflora in Polypectomized Patients

Important dates

Study start
2009
Primary completion
2012
Study completion
2015
First posted
May 6, 2009
Registry last updated
Jul 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.