Effect of probiotic supplementation on gut microbiota in patients with food addiction and weight regain after bariatric surgery

Investigating the effect of probiotic supplementation on the change of intestinal microflora

This study is a Triple-blind Randomized Controlled Clinical Trial with a parallel group design of 50 patients. A simple method has been used for randomization. Randomization unit is Individual. Excel software has been used for randomization. The central service method was used for allocation concealment.

The intervention site is Clinic of National Nutrition Research Institute. Study participants, main study researchers, intervention and treatment partners, data collectors, and data analyzers were blinded in this study, and someone outside the study was used for randomization and labeling of probiotic and placebo supplements.

Inclusion criteria: Age18-50 years, weight regain after bariatric surgery , food addiction Exclusion criteria: Pregnancy, lactation, use of any antibiotics, probiotic product or protein supplement, liver disease, kidney, cancer and thyroid disease, use of weight loss and appetite suppressants

Intervention group: for 12 weeks, 2 Multi-strain probiotic capsules daily (after breakfast and after lunch) with hypocaloric (-300 to 500 kcal/day), high-protein (25% of energy) diet and ten sessions (Once a week individually) of cognitive behavioral therapy (CBT) intervention (online based). Control group: for 12 weeks, 2 placebo capsules daily (after breakfast and after lunch) with hypocaloric (-300 to 500 kcal/day), high-protein (25% of energy) diet and ten sessions (Once a week individually) of cognitive behavioral therapy (CBT) intervention (online based). Supplements are provided by Tekgen Zist company.

Abundance of Eubacterium ؛ Akkermansia ؛ Megamonas ؛ Bifidobacterium ؛ Lactobacillus ؛ Bacteroides

This study is a Triple-blind Randomized Controlled Clinical Trial. A simple method has been used for randomization. Randomization unit is Individual. Excel software has been used for randomization. Using unique codes as ID numbers, and using random numbers generated by the software, participants were randomly assigned to the equal sample size in the intervention and placebo groups. (Description of randomization by Excel software: In the first step, we generated 50 random numbers according to the sample size, in the next step, we obtained the rank of these numbers obtained in the first step, in the third step, we divided these numbers by 25, in the fourth step, the numbers that fell between zero and one were in the intervention group and the rest in the placebo group) The central service method was used for allocation concealment. A person outside the research team allocated unique codes A and B to the supplements, none of the research team members knew which code belonged to the intervention or placebo group

Study participants, main study researchers, intervention and treatment partners, data collectors, and data analyzers were blinded in this study, and someone outside the study was used for randomization and labeling of probiotic and placebo supplements. The list of random numbers was generated by a statistics professor. It was delivered confidentially to the research team of Tachgen Zist company in Excel form. An unknown person from the research team of Tachgen Zist company was chosen by the company manager as the person responsible for blinding the supplements. Probiotic and placebo supplements were given to the research team in a completely similar shape with Numeric and A/B codes. none of the research team members knew which code belonged to the intervention or placebo group.