Microbiome and Bariatric Surgery

Weight Change, Body Clinical Trial

— Biobehavioral  

Official title:

Mechanisms That Predict Weight Trajectory After Bariatric Surgery: The Interactive Roles of Behavior and Biology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03065426
• Other study ID #: BIO-XXX
• Status: Recruiting
• Phase: N/A
• First received: February 22, 2017
• Last updated: May 12, 2017
• Start date: May 11, 2017
• Est. completion date: September 2021

Study information

• Verified date: May 2017
• Source: North Dakota State University
• Contact: Carrie Nelson, BSN
• Phone: 701-365-4918
• Email: cnelson[@]nrifargo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective, 24-month, longitudinal study of patients planning to undergo bariatric surgery (Roux-en-Y Gastric Bypass or Sleeve Gastrectomy) in which we aim to identify correlates and predictors of observed weight loss trajectories following bariatric surgery. This approach will expand current knowledge by examining the combined impact of empirically supported behavioral and biological data in a large sample over time. Intensive measurement of problematic eating behaviors, mood, and compliance with diet and exercise regimens post-surgery will be analyzed in the context of lterations in parallel with, or in response to, changes observed in the gut microbiota. Identifying these post-surgical predictors of weight loss and comorbidity resolution will allow for the development of individualized interventions to optimize surgery-related outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. In evaluation for Roux-en-Y Gastric Bypass or Sleeve Gastrectomy.

2. Age 18-65, inclusive

Exclusion Criteria:

1. Alcohol or substance use disorder in past year

2. Severe psychiatric disorder that may affect ability to complete the protocol

3. Regular tobacco use during the last year

4. Current medication taken routinely and known to impact factors that may affect the gut microbiome

5. Use of any oral or injectable antibiotic in the past month

6. Use of commercially available pre/pro biotic in the past month

7. History of significant disease/disorder that would be expected to impact the microbiome of the gut

8. Inability to engage in physical activity or dietary monitoring

9. Nonprescribed/illicit drug use

10. Pregnant or breastfeeding

Related Conditions & MeSH terms

• Body Weight Changes
• Weight Change, Body

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio
United States	Neuropsychiatric Research Institute	Fargo	North Dakota

Sponsors (3)

Lead Sponsor	Collaborator
North Dakota State University	Neuropsychiatric Research Institute, The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight trajectory	Weight outcomes following bariatric surgery	24 months