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IRCT20220406054437N2 IRCT 2022-11-14 Shahid Beheshti University of Medical Sciences The effect of probiotics on intestinal microbiota Effect of probiotic supplementation on gut microbiota in patients with food addiction and weight regain after bariatric surgery 2022-08-06 anticipated 50 Complete https://irct.ir/trial/64936 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. N/A Food addiction, Weight regain after bariatric surgery. Intervention 1: Intervention group: Participants take 2 Multi-strain probiotic capsules daily (after breakfast and after lunch) for 12 weeks. All individuals are given a hypocaloric (-300 to 500 kcal/day), high-protein (25% of energy) diet based on basal metabolism rate (using indirect calorimetry) and level of physical activity (using metabolic equivalents task: MET). For all individuals, ten sessions (Once a week individually) of Cognitive behavioral therapy (CBT) intervention will be performed online based on the Michael Frey protocol. Each probiotic capsule contains Lactobacillus acidophilus (1.8 × 109 CFU / capsule), Bifidobacterium bifidum (1.8 × 109 CFU / capsule), Bifidobacterium lactis (1.8 × 109 CFU / capsule), Bifidobacterium longul / C, 1.8 (1 × 109 CFU / capsule), Lactobacillus reuteri (1 × 109 CFU / capsule), magnesium stearate and maltodextrin, produced by Tach Gene Zist Company. Intervention 2: Control group: Participants in the control group take two placebo capsules (after breakfast and lunch) daily for 12 weeks, containing 300 mg of starch. The capsules are completely similar in shape, size and color to the intervention capsules and are produced by Tach Gene Zist Company. All individuals are given a hypocaloric (-300 to 500 kcal/day), high-protein (25% of energy) diet based on basal metabolism rate (using indirect calorimetry) and level of physical activity (using metabolic equivalents task: MET). For all individuals, ten sessions (Once a week individually) of Cognitive behavioral therapy (CBT) intervention will be performed online based on the Michael Frey protocol. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Other studies are supposed to be done on these participans in the continuation of this proposal, Therefore, no decision has been made regarding the publication of the data.
public Atoosa Saidpour
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2207 7425 Atoosa.Saidpour@gmail.com Shahid Beheshti University of Medical Sciences scientific Atoosa Saidpour
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2207 7425 Atoosa.Saidpour@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) At least 18 months have passed since the date of bariatric surgery and having weight regain of at least 10% of the lowest weight gained Confirmation of food addiction with yale food addiction scale (YFAS) Being in the age range of 18-50 years 18 years 50 years Both Pregnancy, lactation, menopause professional athlete Use of any type of antibiotic in the last three weeks Using any type of probiotic product or protein supplement in the last month Having liver diseases (other than fatty liver), kidney, cancer and thyroid diseases Use of weight loss and appetite suppressants Treatment - Other Placebo Intervention group: Participants take 2 Multi-strain probiotic capsules daily (after breakfast and after lunch) for 12 weeks. All individuals are given a hypocaloric (-300 to 500 kcal/day), high-protein (25% of energy) diet based on basal metabolism rate (using indirect calorimetry) and level of physical activity (using metabolic equivalents task: MET). For all individuals, ten sessions (Once a week individually) of Cognitive behavioral therapy (CBT) intervention will be performed online based on the Michael Frey protocol. Each probiotic capsule contains Lactobacillus acidophilus (1.8 × 109 CFU / capsule), Bifidobacterium bifidum (1.8 × 109 CFU / capsule), Bifidobacterium lactis (1.8 × 109 CFU / capsule), Bifidobacterium longul / C, 1.8 (1 × 109 CFU / capsule), Lactobacillus reuteri (1 × 109 CFU / capsule), magnesium stearate and maltodextrin, produced by Tach Gene Zist Company. Control group: Participants in the control group take two placebo capsules (after breakfast and lunch) daily for 12 weeks, containing 300 mg of starch. The capsules are completely similar in shape, size and color to the intervention capsules and are produced by Tach Gene Zist Company. All individuals are given a hypocaloric (-300 to 500 kcal/day), high-protein (25% of energy) diet based on basal metabolism rate (using indirect calorimetry) and level of physical activity (using metabolic equivalents task: MET). For all individuals, ten sessions (Once a week individually) of Cognitive behavioral therapy (CBT) intervention will be performed online based on the Michael Frey protocol. Bacteroides Abundance in the stool sample. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: Polymerase chain reaction (PCR) in stool samples. Lactobacillus Abundance in the stool sample. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: Polymerase chain reaction (PCR) in stool samples. Bifidobacterium Abundance in the stool sample. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: Polymerase chain reaction (PCR) in stool samples. Megamonas Abundance in the stool sample. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: Polymerase chain reaction (PCR) in stool samples. Eubacterium Abundance in the stool sample. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: Polymerase chain reaction (PCR) in stool samples. Akkermansia Abundance in the stool sample. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: Polymerase chain reaction (PCR) in stool samples. Shahid Beheshti University of Medical Sciences Approved 2022-03-14 Ethics committee of national nutrition and food thechnology research institute No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town Tehran Tehran Iran (Islamic Republic of)