Intestinal Microbiota in Patients Before and After Bariatric Surgery and Healthy Controls

Study Overview
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Brief Summary
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Studying obesity and metabolic syndrome attention is focused more and more on gut microbiota. In humans and animals, bariatric surgery (mainly gastric bypass surgery) lead to alterations of gut microbiota, which seem to be favourable. In this study the investigators aim to examine the effect of different bariatric procedures on composition of gut microbiota.

Detailed Description
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The human gastrointestinal tract is home to an extremely numerous and diverse collection of microbes communities, collectively termed the intestinal microbiota. This amazingly complex and poorly understood group of communities has an enormous impact on humans. Indeed, microbiota is considered to play a number of key roles in the maintenance of host health, including aiding digestion of otherwise indigestible dietary compounds, synthesis of vitamins and other beneficial metabolites, immune system regulation and enhanced resistance against colonization by pathogenic microorganisms. Conversely, the intestinal microbiota is also a potent source of antigens and potentially harmful compounds. Schematically, humans can be considered to exist in a state of natural balance with their microbial inhabitants. A shift in the balance of microbiota composition such that it may become deleterious to host health is termed dysbiosis. Dysbiosis of the gut microbiota has been implicated in numerous disorders, ranging from intestinal such as inflammatory bowel diseases and colorectal cancer to disorders with more systemic effects such as diabetes, obesity, insulin resistance and steatohepatitis. The link between the microbes in the human gut and the development of obesity, cardiovascular disease and metabolic syndromes, such as type 2 diabetes, is becoming clearer but, because of the complexity of the microbial community, the functional connections are less well understood. In humans and animals, bariatric surgery (mainly gastric bypass surgery) lead to alterations of gut microbiota, which seem to be favourable. In this study the investigators aim to examine the effect of different bariatric procedures on composition of gut microbiota.

Official Title
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Characterization of Intestinal Microbiota in Healthy Subjects and Patients Before and After Bariatric Surgery Using Next Generation Sequencing Methods

Conditions
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Obesity

Intervention / Treatment
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* Procedure: Gastric Bypass or Sleeve gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 30 healthy controls: BMI 18-30kg/m2 good general health 40 morbidly obese patients (BMI >35kg/m2) scheduled for either sleeve gastrectomy or gastric bypass surgery Exclusion Criteria: Antibiotic therapy within the last 2 months before enrolment regular intake of proton pump Inhibitors (PPI) previous surgery on the gastrointestinal tract (appendectomy acceptable)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gastric Bypass Group<br>Twenty morbidly obese patients undergoing gastric bypass surgery | Procedure: Gastric Bypass or Sleeve gastrectomy<br> <br> |
| Active Comparator: Sleeve Group<br>Twenty morbidly obese patients undergoing sleeve gastrectomy | Procedure: Gastric Bypass or Sleeve gastrectomy<br> <br> |
| No Intervention: Healthy controls<br>Thirty healthy, lean controls | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of of gut microbiome using next generation sequencing technology |  | six months postoperatively |