Skip to main content
OpenTrials
Completed

NCT Number: NCT03412149

Three M Study (Malabsorption, Microbiota, Mini-Gastric Bypass)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity (Disorder) Body Weight Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ICOT Hospital

Latina, 04100, Italy

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Mini Gastric Bypass

Procedure

Standardization of the techniques will be guaranteed:

  • Mini Gastric Bypass Arm
  • Roux en Y Gastric Bypass arm All patients will have intraoperative measurement of the whole length of bowel from Treitz ligament to the ileocecal junction (expected range 6-8 m).The common limb will be therefore about 2/3 of total small bowel length.

Roux en Y gastric bypass

Procedure

Standardization of the techniques will be guaranteed:

  • Mini Gastric Bypass Arm
  • Roux en Y Gastric Bypass arm All patients will have intraoperative measurement of the whole length of bowel from Treitz ligament to the ileocecal junction (expected range 6-8 m).The common limb will be therefore about 2/3 of total small bowel length.

Primary outcomes

  1. Gut Microbiota

    Time frame: 0-6-12 Months

    To evaluate and compare Roux en Y Gastric Bypass vs Mini Gastric Bypass microbiota profile shift 1 year after surgery and its impact on metabolic and nutritional status after surgery.

Secondary outcomes

  1. Glucagon - like peptide 1 (GLP-1)

    Time frame: 0-12 Months

    To measure GLP-1 plasma level before and 12 months after surgery in MGB vs RYGB patients

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 26, 2018
Registry last updated
Apr 28, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.