NCT02563119

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2015

Completed
Last Updated

September 29, 2015

Status Verified

September 1, 2015

Enrollment Period

1.7 years

First QC Date

September 28, 2015

Last Update Submit

September 28, 2015

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Characterization of of gut microbiome using next generation sequencing technology

    six months postoperatively

Study Arms (3)

Gastric Bypass Group

ACTIVE COMPARATOR

Twenty morbidly obese patients undergoing gastric bypass surgery

Procedure: Gastric Bypass or Sleeve gastrectomy

Sleeve Group

ACTIVE COMPARATOR

Twenty morbidly obese patients undergoing sleeve gastrectomy

Procedure: Gastric Bypass or Sleeve gastrectomy

Healthy controls

NO INTERVENTION

Thirty healthy, lean controls

Interventions

Gastric Bypass or Sleeve gastrectomyPROCEDURE
Gastric Bypass GroupSleeve Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy controls: BMI 18-30kg/m2 good general health
  • morbidly obese patients (BMI \>35kg/m2) scheduled for either sleeve gastrectomy or gastric bypass surgery

You may not qualify if:

  • Antibiotic therapy within the last 2 months before enrolment
  • regular intake of proton pump Inhibitors (PPI)
  • previous surgery on the gastrointestinal tract (appendectomy acceptable)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel,Division of Gastroenterology and Hepatology

Basel, CH-4031, Switzerland

Location

MeSH Terms

Conditions

Obesity

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Christoph Beglinger, Prof.

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2015

First Posted

September 29, 2015

Study Start

October 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

September 29, 2015

Record last verified: 2015-09

Locations

CH(1)