Microbiome and Bariatric Surgery
Status unconfirmed
Conditions studied: Weight Change, Body
In brief
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.
Key facts
- Study ID
- NCT03065426
- Run by
- North Dakota State University
- People needed
- 144
- Starts
- 2017-05-11
- Expected to finish
- 2021-09-01
- Last updated by the study team
- 2017-05-16
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- In evaluation for Roux-en-Y Gastric Bypass or Sleeve Gastrectomy.
- Age 18-65, inclusive
You may not qualify if…
- Alcohol or substance use disorder in past year
- Severe psychiatric disorder that may affect ability to complete the protocol
- Regular tobacco use during the last year
- Current medication taken routinely and known to impact factors that may affect the gut microbiome
- Use of any oral or injectable antibiotic in the past month
- Use of commercially available pre/pro biotic in the past month
- History of significant disease/disorder that would be expected to impact the microbiome of the gut
- Inability to engage in physical activity or dietary monitoring
- Nonprescribed/illicit drug use
- Pregnant or breastfeeding
Where it is running
- Neuropsychiatric Research Institute — Fargo, North Dakota, United States (enrolling)
- Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.