Clinical trial NCT03412149: Three M Study (Malabsorption, Microbiota, Mini-Gastric Bypass)
Official title: Malabsorption and Gut Microbiota Profile Changes After Laparoscopic Mini-Gastric Bypass (MGB) vs Roux-en-Y Gastric Bypass (RYGB): a Prospective Multicenter Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity (Disorder)
Keywords: Malabsorption, Mini Gastric Bypass, Roux en Y Gastric Bypass
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Bariatric surgery represents the best therapeutic option to induce sustainable weight loss and to solve serious comorbidities improving the life-expectancy and the quality of life. Actually the choice of the procedure is based on the surgeon's and patients preference . Mini gastric bypass(MGB) is an emerging procedure offering excellent results in terms of weight loss and comorbidities (mainly metabolic) control. On the other hand, recent data indicated that the gut microbiota may mediate some of the beneficial effects of bariatric surgery and changes in the composition and diversity of the gut microbiota have been observed after RY Gastric Bypass (RYGB) in humans as well as in mice. However, there are no prospective investigations on Gut Microbiota changes after MGB, despite the procedure is described as "malabsorptive" and there are no studies comparing gut microbiota shift and malabsorption entity in humans after RYGB vs MGB. Thereafter prospective data on the incidence of bile reflux esophageal lesions after MGB are lacking.

The aim of the present multicentric prospective comparative study is to evaluate malabsorption and gut microbiota shift after laparoscopic RYGB vs MGB at 1 year.


Eligibility criteria: Inclusion Criteria:

* BMI 40-55 kg/m2
* Non smokers
* Primary Mini Gastric Bypass or Roux en Y Gastric Bypass without any concomitant surgeries except hiatal hernia repair
* Enrollment in the two study groups will be on the basis of patient choice.

Exclusion Criteria:

* Smokers
* Different bowel measurement (plus or minus 10%).
* Conversion to open surgery, reoperation
* Helicobacter Pylori positive previous or current
* Free PPI 4 weeks before 6th month (after surgery)
* Corticosteroids, vitamine E, fish oil treatment 2 months before surgery
* Anti or pre- biotics treatment 2 months before surgery
* Chronic gastrointestinal diseases or syndromes
* Previous bariatric surgery (intragastric balloon excluded)
* Previous resective bowel surgery
* Previous pancreatic surgery
* Previous Hepato BilioPancreatic surgery
* Gallbladder gallstones

Primary outcomes:
measure: Gut Microbiota
timeFrame: 0-6-12 Months
Secondary outcomes:
measure: Glucagon - like peptide 1 (GLP-1)
timeFrame: 0-12 Months
Other outcomes:
Locations:
city: Latina
country: Italy
facility: ICOT Hospital
Study officials:
affiliation: University of Roma La Sapienza
name: Gianfranco Silecchia, MD PhD
role: PRINCIPAL_INVESTIGATOR
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