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IRCT20190423043356N4 IRCT 2023-08-07 Mashhad University of Medical Sciences The effect of probiotics in postoperative constipation in bariatric surgery patients The effect of probiotics in postoperative constipation in bariatric surgery patients 2023-08-06 anticipated 27 Complete https://irct.ir/trial/70473 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: It is a diagnostic and therapeutic method, Randomization description: Patients will be individually randomized using the block randomization method in quadruple blocks by randomization.com website, Allocation concealment will be done using sealed, opaque, and sequentially numbered envelopes, Blinding description: Patients, The nurse who collects the data, Data analyzer. N/A Morbid Obesity. Intervention 1: Intervention group: Bariatric surgery patients receiving probiotics. Intervention 2: Control group: Bariatric surgery patients receiving placebo. 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 After the publication of the article, the decision is made
public Mashhad University of Medical Sciences
Imam Reza Hospital
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3180 2557 Daliliam@mums.ac.ir Mashhad University of Medical Sciences scientific Amin Dalili
Surgical Oncology Research Center, Imam Reza Hospital, Mashhad University of Medical Sciences
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3180 2557 Daliliam@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with BMI greater than 40 with or without obesity-related comorbidities Patient with BMI 35-40 with medical comorbidity A patient who has failed a weight loss diet under the supervision of a doctor The patient is psychiatrically stable Confirmation of patients' constipation based on Rome's criteria after one month of surgery no limit no limit Both A disease that makes anesthesia or surgery dangerous for the patient The patient is mentally incompetent to understand the operation technique Inability or unwillingness to change lifestyle after surgery Abuse of drugs and alcohol or any other addiction Active bulimia nervosa or other eating disorders The patient is psychiatrically unstable Unsupportive family Non-confirmation of patients' constipation based on Rome's criteria after one month of surgery E66.01 Morbid (severe) obesity due to excess calories Treatment - Drugs Placebo Intervention group: Bariatric surgery patients receiving probiotics Control group: Bariatric surgery patients receiving placebo The severity of constipation. Timepoint: Visit at the end of the first, second, fourth, sixth and eighth week. Method of measurement: Physical examination by the surgeon and according to Rome IV Criteria. Mashhad University of Medical Sciences Approved 2023-05-01 Ethics committee of Mashhad University of Medical Sciences Imam Reza Hospital, Ibn-e-Sina St Mashhad Razavi Khorasan Iran (Islamic Republic of)