Microbes and Bariatric Surgery | NCT01130207

Studies
Microbes and Bariatric Surgery

NCT01130207

Sponsor

State University of New York - Upstate Medical University

Status

Completed

Last Update Posted

Nov 19, 2014Estimated

Enrollment

34Actual

Phase

Not provided

Conditions

Obesity
Diabetes
Periodontal Disease

Interventions

Not provided

Countries

United States

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

Nov 2014

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

May 2010

Primary Completion Date

Aug 2013Actual

Completion Date

Aug 2013Actual

First Submitted Date

May 24, 2010

First Submission Date that Met QC Criteria

May 24, 2010

First Posted Date

May 25, 2010Estimated

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

Nov 17, 2014

Last Update Posted Date

Nov 19, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Edward J. Shillitoe, Professor, State University of New York - Upstate Medical UniversityPrincipal Investigator

Lead Sponsor

State University of New York - Upstate Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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 investigators will study people who are obese and will be treated by bariatric surgery. The investigators will test the hypothesis that some of the features of obesity are related to the bacteria in the gastro-intestinal tract.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

34Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in microflora after bariatric surgery	Specific differences were measured in oral and intestinal bacteria immediately after surgery.	Six months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ages 18-65
Will undergo bariatric surgery for treatment of obesity in Syracuse NY
Willingness to participate

Exclusion Criteria:

Any previous gastrointestinal surgery
Use of antibiotics in the previous 3 months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with obesity who are already accepted for treatment by bariatric surgery in Syracuse NY

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Upstate Medical University		Syracuse	New York	13210	United States

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D003920	Diabetes Mellitus
D010510	Periodontal Diseases

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

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Browse Branches

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