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Completed

NCT Number: NCT02563119

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel,Division of Gastroenterology and Hepatology

Basel, CH-4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Gastric Bypass or Sleeve gastrectomy

Procedure

Primary outcomes

  1. Characterization of of gut microbiome using next generation sequencing technology

    Time frame: six months postoperatively

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 29, 2015
Registry last updated
Sep 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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