Recruiting

Microbiome & Bariatric Surgery

Sponsor:

North Dakota State University

Code:

NCT03065426

Conditions

Weight Change, Body

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Weight Change, Body

Study ID

NCT03065426

Start date

May 11, 2017

Status verified date

May, 2017

Completion date

Sep, 2021

Anticipated

Primary completion date

Sep, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

144 participants

Anticipated

Interventions and Outcome Measures

Arms

Roux-en-Y Gastric Bypass

Patients planning to undergo Roux-en-Y Gastric Bypass will be invited to participate in this study.

Sleeve Gastrectomy

Patients planning to undergo Sleeve Gastrectomy will be invited to participate in this study.

Primary outcome measure

  • Weight trajectory [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Carrie Nelson, BSN

701-365-4918cnelson@nrifargo.com

Locations

Neuropsychiatric Research Institute

Recruiting

Fargo, North Dakota, United States, 58103

Principal Investigator:

Kristine Steffen

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Principal Investigator:

Leslie Heinberg

More Information

Sponsor

North Dakota State University

Last update posted

May 16, 2017

Last verified

May, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by North Dakota State University on 2017-05-16.