Beta-glucan on Fecal Microflora in Polypectomized Patients | NCT00893659

Studies
Beta-glucan on Fecal Microflora in Polypectomized Patients

NCT00893659

Sponsor

Harokopio University

Status

Completed

Last Update Posted

Jul 24, 2015Estimated

Enrollment

69Actual

Phase

Not Applicable

Conditions

Polypectomized Patients

Interventions

wheat bread with beta-glucan
wheat bread without beta-glucan

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Dec 2012Actual

Completion Date

Jul 2015Actual

First Submitted Date

May 5, 2009

First Submission Date that Met QC Criteria

May 5, 2009

First Posted Date

May 6, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2015

Last Update Posted Date

Jul 24, 2015Estimated

Name	Class
JOTIS S.A. FOOD INDUSTRY, GREECE	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

69Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
wheat bread with beta-glucan supplementation	Experimental		Dietary Supplement: wheat bread with beta-glucan
wheat bread without beta-glucan	Placebo Comparator		Dietary Supplement: wheat bread without beta-glucan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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 with beta-glucan supplementation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To measure the effect of beta-glucan on fecal microflora (number of bacteria, bacterial enzyme activity, SCFA, pH).		four months
To observe the effect of beta-glucan on intestinal symptoms and well-being.		four months

Secondary Outcomes

Measure	Description	Time Frame
To study the fecal water cyto- and/or genotoxicity on HT-29 cell line.		one year

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adamantini Kyriacou, Ass. Professor	Harokopio University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Harokopio University		Athens	Attica	17671	Greece

Intervention Browse Module

MeSH Terms

ID	Term
D047071	beta-Glucans

Ancestor Terms

ID	Term
D005936	Glucans
D011134	Polysaccharides
D002241	Carbohydrates

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