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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Procedure: Gastric Bypass or Sleeve gastrectomy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, CH-4031
    • University Hospital Basel,Division of Gastroenterology and Hepatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: September 28, 2015
• First Submitted That Met QC Criteria: September 28, 2015
• First Posted (Estimate): September 29, 2015

Study Record Updates

• Last Update Posted (Estimate): September 29, 2015
• Last Update Submitted That Met QC Criteria: September 28, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: CBeglinger