Obesity (Disorder) Clinical Trial
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
| Verified date | April 2021 |
| Source | University of Roma La Sapienza |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 90 |
| Est. completion date | November 19, 2020 |
| Est. primary completion date | February 19, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Italy | ICOT Hospital | Latina |
| Lead Sponsor | Collaborator |
|---|---|
| University of Roma La Sapienza |
Italy,
Alexandrou A, Davis PA, Law S, Whooley BP, Murthy SC, Wong J. Esophageal cancer in patients with a history of distal gastrectomy. Arch Surg. 2002 Nov;137(11):1238-42. — View Citation
Bruzzi M, Rau C, Voron T, Guenzi M, Berger A, Chevallier JM. Single anastomosis or mini-gastric bypass: long-term results and quality of life after a 5-year follow-up. Surg Obes Relat Dis. 2015 Mar-Apr;11(2):321-6. doi: 10.1016/j.soard.2014.09.004. Epub 2014 Sep 16. — View Citation
Campanile FC, Boru CE, Rizzello M, Puzziello A, Copaescu C, Cavallaro G, Silecchia G. Acute complications after laparoscopic bariatric procedures: update for the general surgeon. Langenbecks Arch Surg. 2013 Jun;398(5):669-86. doi: 10.1007/s00423-013-1077-2. Epub 2013 Mar 22. Review. — View Citation
Cavin JB, Voitellier E, Cluzeaud F, Kapel N, Marmuse JP, Chevallier JM, Msika S, Bado A, Le Gall M. Malabsorption and intestinal adaptation after one anastomosis gastric bypass compared with Roux-en-Y gastric bypass in rats. Am J Physiol Gastrointest Liver Physiol. 2016 Sep 1;311(3):G492-500. doi: 10.1152/ajpgi.00197.2016. Epub 2016 Jul 14. — View Citation
Donini LM, Brunani A, Sirtori A, Savina C, Tempera S, Cuzzolaro M, Spera G, Cimolin V, Precilios H, Raggi A, Capodaglio P; SIO-ISDCA Task Force. Assessing disability in morbidly obese individuals: the Italian Society of Obesity test for obesity-related disabilities. Disabil Rehabil. 2011;33(25-26):2509-18. doi: 10.3109/09638288.2011.575529. Epub 2011 May 4. — View Citation
Graessler J, Qin Y, Zhong H, Zhang J, Licinio J, Wong ML, Xu A, Chavakis T, Bornstein AB, Ehrhart-Bornstein M, Lamounier-Zepter V, Lohmann T, Wolf T, Bornstein SR. Metagenomic sequencing of the human gut microbiome before and after bariatric surgery in obese patients with type 2 diabetes: correlation with inflammatory and metabolic parameters. Pharmacogenomics J. 2013 Dec;13(6):514-22. doi: 10.1038/tpj.2012.43. Epub 2012 Oct 2. — View Citation
Lee WJ, Lee YC, Ser KH, Chen SC, Chen JC, Su YH. Revisional surgery for laparoscopic minigastric bypass. Surg Obes Relat Dis. 2011 Jul-Aug;7(4):486-91. doi: 10.1016/j.soard.2010.10.012. Epub 2010 Oct 30. — View Citation
Lee WJ, Ser KH, Lee YC, Tsou JJ, Chen SC, Chen JC. Laparoscopic Roux-en-Y vs. mini-gastric bypass for the treatment of morbid obesity: a 10-year experience. Obes Surg. 2012 Dec;22(12):1827-34. doi: 10.1007/s11695-012-0726-9. — View Citation
Liou AP, Paziuk M, Luevano JM Jr, Machineni S, Turnbaugh PJ, Kaplan LM. Conserved shifts in the gut microbiota due to gastric bypass reduce host weight and adiposity. Sci Transl Med. 2013 Mar 27;5(178):178ra41. doi: 10.1126/scitranslmed.3005687. — View Citation
Madan AK, Harper JL, Tichansky DS. Techniques of laparoscopic gastric bypass: on-line survey of American Society for Bariatric Surgery practicing surgeons. Surg Obes Relat Dis. 2008 Mar-Apr;4(2):166-72; discussion 172-3. Epub 2007 Dec 19. — View Citation
Milone M, De Placido G, Musella M, Sosa Fernandez LM, Sosa Fernandez LV, Campana G, Di Minno MN, Milone F. Incidence of Successful Pregnancy After Weight Loss Interventions in Infertile Women: a Systematic Review and Meta-Analysis of the Literature. Obes Surg. 2016 Feb;26(2):443-51. doi: 10.1007/s11695-015-1998-7. Review. — View Citation
Musella M, Apers J, Rheinwalt K, Ribeiro R, Manno E, Greco F, Cierny M, Milone M, Di Stefano C, Guler S, Van Lessen IM, Guerra A, Maglio MN, Bonfanti R, Novotna R, Coretti G, Piazza L. Efficacy of Bariatric Surgery in Type 2 Diabetes Mellitus Remission: the Role of Mini Gastric Bypass/One Anastomosis Gastric Bypass and Sleeve Gastrectomy at 1 Year of Follow-up. A European survey. Obes Surg. 2016 May;26(5):933-40. doi: 10.1007/s11695-015-1865-6. — View Citation
Musella M, Milone M, Deitel M, Kular KS, Rutledge R. What a Mini/One Anastomosis Gastric Bypass (MGB/OAGB) Is. Obes Surg. 2016 Jun;26(6):1322-3. doi: 10.1007/s11695-016-2168-2. — View Citation
Noun R, Skaff J, Riachi E, Daher R, Antoun NA, Nasr M. One thousand consecutive mini-gastric bypass: short- and long-term outcome. Obes Surg. 2012 May;22(5):697-703. doi: 10.1007/s11695-012-0618-z. — View Citation
Peterson LA, Zeng X, Caufield-Noll CP, Schweitzer MA, Magnuson TH, Steele KE. Vitamin D status and supplementation before and after bariatric surgery: a comprehensive literature review. Surg Obes Relat Dis. 2016 Mar-Apr;12(3):693-702. doi: 10.1016/j.soard.2016.01.001. Epub 2016 Jan 6. Review. — View Citation
Rutledge R, Walsh TR. Continued excellent results with the mini-gastric bypass: six-year study in 2,410 patients. Obes Surg. 2005 Oct;15(9):1304-8. — View Citation
Rutledge R. The mini-gastric bypass: experience with the first 1,274 cases. Obes Surg. 2001 Jun;11(3):276-80. — View Citation
Tremaroli V, Karlsson F, Werling M, Ståhlman M, Kovatcheva-Datchary P, Olbers T, Fändriks L, le Roux CW, Nielsen J, Bäckhed F. Roux-en-Y Gastric Bypass and Vertical Banded Gastroplasty Induce Long-Term Changes on the Human Gut Microbiome Contributing to Fat Mass Regulation. Cell Metab. 2015 Aug 4;22(2):228-38. doi: 10.1016/j.cmet.2015.07.009. — View Citation
Wang W, Wei PL, Lee YC, Huang MT, Chiu CC, Lee WJ. Short-term results of laparoscopic mini-gastric bypass. Obes Surg. 2005 May;15(5):648-54. — View Citation
* Note: There are 19 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Gut Microbiota | 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. | 0-6-12 Months | |
| Secondary | Glucagon - like peptide 1 (GLP-1) | To measure GLP-1 plasma level before and 12 months after surgery in MGB vs RYGB patients | 0-12 Months |