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Beta-glucan on Fecal Microflora in Polypectomized Patients

H

Harokopio University

Status

Completed

Conditions

Polypectomized Patients

Treatments

Dietary Supplement: wheat bread with beta-glucan
Dietary Supplement: wheat bread without beta-glucan

Study type

Interventional

Funder types

Other

Identifiers

NCT00893659
HAR-GLUCAN-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

69 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

69 participants in 2 patient groups, including a placebo group

wheat bread with beta-glucan supplementation
Experimental group
Treatment:
Dietary Supplement: wheat bread with beta-glucan
wheat bread without beta-glucan
Placebo Comparator group
Treatment:
Dietary Supplement: wheat bread without beta-glucan

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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