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IRCT20220702055340N1 IRCT 2022-11-21 Esfahan University of Medical Sciences Probiotic in ROUX_en_Y obesity surgery on gastrointestinal function and metabolic factors and weight changes Evaluation of the effect of administering probiotic tablets after ROUX-en-Y obesity surgery on gastrointestinal function and metabolic factors and weight changes 2022-07-23 anticipated 134 Complete https://irct.ir/trial/64543 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Eligible patients were selected from patients who refer to the clinic of Al-Zahra Hospital. Software:Random Allocation Software 2.0; Numbering sequential from1 to 134 by analyzer. Block randomization consisting 4 patients in each block. Patients categorized to group A,B. Patient get one pocket that been one number and name of group inside. Just pharmacist know about group A and B. pharmacist take them the tablets and then analyzer entered the data, Blinding description: The probiotic and placebo were determined by the bio-fermentation pharmaceutical company and the samples in each group were delivered to the researcher after the coding under the names of A and B. the groups were decoded after statistical analysis. In this study, the patients, data collectors and data analysts were unaware of the received interventions. 3 Condition 1: Morbid obesity. Condition 2: Bariatric surgery. Intervention 1: Intervention group: The first group received the probiotic tablets (Familact Co.) daily and started receiving medication one week after surgery until 6 months after surgery.After 4 months of surgery, vitamin B12 were prescribed every month. Other necessary supplements were also prescribed. Intervention 2: Control group: Patients underwent bariatric surgery and start receiving placebo one week after surgery and start investigation. Placebo was produced by Zist_Takhmir CO that produce the Femilact. Placebo was produced with the same shape without effective material.After 4 months of surgery, vitamin B12 were prescribed every month. Other necessary supplements were also prescribed. Yes - There is a plan to make this available What will be shared: Outcome of this study Patients information When: At the end of the study. To whom: Journals, Medical Schools Conditions: To use for other patients or use for other study Where to obtain: Alime Hossein Abdolahi a.abdolahi155@gmail.com Dr.Hamid melali Hamidmelali@yahoo.com How to obtain: They have to explain about their study and how to use our data. They request the formal letter by email, data will send during one week. Comments:
public Hamid Melali
General Surgery Department, Alzahra hospital, Sofe Blvd.
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 Hamidmelali@yahoo.com Esfahan University of Medical Sciences scientific Alime Hossein Abdolahi
No 49, 7th Ave,. Sepahan Town. Hezarjarib Blvd.
Isfahan Iran (Islamic Republic of) 8174614141 +98 31 3673 0869 a.abdolahi155@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) BMI ≥ 45 kg/m2 35 ≤BMI ≤40 kg/m2 associated with comorbidity no limit no limit Both having evidence of chronic gastrointestinal, hepatic or renal disorders having evidence of chronic hepatic disorders having evidence of chronic renal disorders Pregnancy Breastfeeding in women Recieving antibiotics, probiotics or probiotic enriched foods, non-steroid anti-inflammatory drugs (NSAID) or insulin within 4 weeks before the study initiation. History of gastrointestinal surgeries E66.01 Z98.84 Morbid (severe) obesity due to excess calories Bariatric surgery status Treatment - Drugs Placebo Intervention group: The first group received the probiotic tablets (Familact Co.) daily and started receiving medication one week after surgery until 6 months after surgery.After 4 months of surgery, vitamin B12 were prescribed every month. Other necessary supplements were also prescribed Control group: Patients underwent bariatric surgery and start receiving placebo one week after surgery and start investigation. Placebo was produced by Zist_Takhmir CO that produce the Femilact. Placebo was produced with the same shape without effective material.After 4 months of surgery, vitamin B12 were prescribed every month. Other necessary supplements were also prescribed. Gastrointestinal Function. Timepoint: start receiving medication 1 week after surgery and start investigation, 5week after surgery, 9weeks after surgery, 12 week after surgery then 6 month after surgery. Method of measurement: Using of Gastrointestinal Quality of Life index questionnaire. Blood sugar. Timepoint: Before surgery and after surgery for up to 6 months. Method of measurement: Blood test. Liver enzyme. Timepoint: Before surgery and after surgery for up to 6 months. Method of measurement: Blood test. Triglyceride. Timepoint: Before surgery and after surgery for up to 6 months. Method of measurement: Blood test. HbA1C. Timepoint: Before surgery and after surgery for up to 6 months. Method of measurement: Blood test. Esfahan University of Medical Sciences Approved 2020-12-19 Ethics committee of Isfahan University of Medical Sciences No.49, 7th Ave., Sepahan Town.,Hezarjarib Blvd.,Isfahan Isfahan Isfehan Iran (Islamic Republic of)