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Microbes and Bariatric Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Edward J. Shillitoe, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT01130207
First received: May 24, 2010
Last updated: November 17, 2014
Last verified: November 2014
  Purpose

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.


Condition
Obesity
Diabetes
Periodontal Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effects of Bariatric Surgery on the Gastro-intestinal Microflora

Resource links provided by NLM:


Further study details as provided by State University of New York - Upstate Medical University:

Primary Outcome Measures:
  • Changes in microflora after bariatric surgery [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Specific differences were measured in oral and intestinal bacteria immediately after surgery.


Biospecimen Retention:   Samples With DNA

Bacterial samples from dental plaque and feces, and serum


Enrollment: 34
Study Start Date: May 2010
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01130207

Locations
United States, New York
Upstate Medical University
Syracuse, New York, United States, 13210
Sponsors and Collaborators
State University of New York - Upstate Medical University
  More Information

No publications provided

Responsible Party: Edward J. Shillitoe, Professor, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT01130207     History of Changes
Other Study ID Numbers: Microbes and Bariatric Surgery
Study First Received: May 24, 2010
Last Updated: November 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York - Upstate Medical University:
Obesity
Diabetes
Periodontal disease

Additional relevant MeSH terms:
Obesity
Periodontal Diseases
Body Weight
Mouth Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Stomatognathic Diseases

ClinicalTrials.gov processed this record on November 20, 2014