The impact of Hafnia alvei HA4597™ on weight loss and glycaemic control after bariatric surgery - study protocol for a triple-blinded, blocked randomized, 12-month, parallel-group, placebo-controlled clinical trial

Abstract

Background Subjects with obesity exhibit changes in gut microbiota composition and function (i.e. dysbiosis) that contribute to metabolic dysfunction, including appetite impairment. Although bariatric surgery is an effective treatment for obesity with a great impact on weight loss, some subjects show weight regain due to increased energy intake after the surgery. This surgery involves gut microbiota changes that promote appetite control, but it seems insufficient to completely restore the obesity-associated dysbiosis - a possible contributor for weight regain. Thus, modulating gut microbiota with probiotics that could improve appetite regulation as a complementary approach to post-operative diet (i.e. Hafnia alvei HA4597 (TM)), may accentuate post-surgery weight loss and insulin sensitivity. Methods This is a protocol of a triple-blinded, blocked-randomized, parallel-group, placebo-controlled clinical trial designed to determine the effect of Hafnia alvei HA4597 (TM) supplementation on weight loss and glycaemic control 1 year after bariatric surgery. Patients of Hospital CUF Tejo, Lisbon, that undergo Roux-en-Y gastric bypass are invited to participate in this study. Men and women between 18 and 65 years old, with a BMI = 35 kg/m(2) and at least one severe obesity-related comorbidity, or with a BMI = 40 kg/m(2), and who are willing to take 2 capsules of Hafnia alvei HA4597 (TM) probiotic supplements (equivalent to 5 x-10(7) CFU) vs. placebo per day for 90 days are included in this study. Assessments are carried out at baseline, 3, 6, 9, and 12 months after the surgery. Loss of weight in excess and glycated haemoglobin are considered primary outcomes. In addition, changes in other metabolic and inflammatory outcomes, gut microbiota composition and metabolites, as well as gastrointestinal quality of life are also being assessed during the trial. Discussion The evidence obtained in this study will provide relevant information regarding the profile of the intestinal microbiota of individuals with severe obesity and the identification of the risk/benefit ratio of the use of Hafnia alvei HA4597 (TM) as an adjunctive treatment in the maintenance of metabolic and weight control one year after the surgical intervention.