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IRCT20170608034390N11 IRCT 2022-05-14 Shahid Beheshti University of Medical Sciences Effects of Probiotics on Constipation & Symptoms of Parkinson Disease Evaluating the Efficacy of Probiotics in Constipation & Motor Dysfunctions in patients with Idiopathic Parkinson Disease 2022-06-22 anticipated 30 Complete https://irct.ir/trial/62963 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: We will randomly divide the participants into two groups with the same size of 15 participants (30 patients in total), to ensure the equal distribution of patients in the two groups, the block randomization method will be used, and 5 blocks of 6 people in total will be created. Sealed Envelope online software will be used to create random codes. Patients who meet the inclusion criteria receive the code in order and based on the grouping of random blocks, for example, the distribution and coding in the first block is as follows, the first patient Group A, the unique code is ZX6, the second patient Group A, the unique code is GA6, Group B third patient, FR9 code, Group B fourth patient, PP3 code, Group A fifth patient, FR9 code, Group B sixth patient, AE8 code. The number of patients in groups A and B in each block is equal, but the random sequence will be different, Blinding description: After preparing the medicine and placebo, they will be packed in the same box by a clinical laboratory expert who is outside the researchers and will be provided with random codes based on the Excel file extracted from the Sealed Envelope software. The package will be transported to the clinic and the codes will remain closed until the statistical analysis is performed. 3 Parkinson's Disease. The intervention group will take an oral capsule containing probiotics for 8 weeks before going to bed. Both groups will receive nutritional training and non-pharmacological strategies for treating constipation in the form of brochures. The intervention product and placebo will be provided by Fara Daroo Fanavar Mehr Company, with the same packaging, shape, taste and smell.. Yes - There is a plan to make this available What will be shared: potentially the whole data will be published after participants become unidentified. When: The data will be available 6 months after data publish. To whom: Industrial and Academic Researchers Conditions: To carry out further research Where to obtain: Dr. Hadi Esmaily, School of Pharmacy, Shahid Beheshti University of Medical Sciences. How to obtain: It will be available through an email to corresponding author Comments:
public Hadi Esmaily
School of Pharmacy, Shahid Beheshti University of Medical Sciences
Tehran Iran (Islamic Republic of) 1996835113 +98 21 8887 3704 esmaily_hadi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Hadi Esmaily
School of Pharmacy, Shahid Beheshti University of Medical Sciences, Valiasr ST.
Tehran Iran (Islamic Republic of) 1996835113 +98 21 8887 3704 Esmaily_hadi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with Idiopathic Parkinson Disease With Rome IV criteria for functional constipation Age equal to or above 60 years Agreed to sign the informed written consent 60 years no limit Both There is a contraindication to probiotics, such as previous allergies to it Patients with active infection diagnosis Patients being treated with antibiotics. Patients less than 60 years Patients receiving other probiotics Patients who regularly use laxatives Patients who are immunocompromised Patients who are receiving traditional medicine products to relieve constipation. Patients who are receiving drugs that have a high risk of constipation in the complication profile with a high risk of 10%. (Except for FDA approved drugs in the treatment of Parkinson's) G20 Parkinson's disease Treatment - Drugs The intervention group will take an oral capsule containing probiotics for 8 weeks before going to bed. Both groups will receive nutritional training and non-pharmacological strategies for treating constipation in the form of brochures. The intervention product and placebo will be provided by Fara Daroo Fanavar Mehr Company, with the same packaging, shape, taste and smell. Number of defecation per week. Timepoint: The beginning of the study and the end of the study. Method of measurement: Defecation booklet. Unified Parkinson's Disease Rating Scale (UPDRS). Timepoint: The beginning of the study and the end of the study. Method of measurement: Unified Parkinson's Disease Rating Scale (UPDRS) Questionnaire. Defecation consistency. Timepoint: The beginning of the study and the end of the study. Method of measurement: Bristol stool scale. Sensation of complete evacuation. Timepoint: The beginning of the study and the end of the study. Method of measurement: Defecation booklet. Frequency of medication interventions to improve constipation. Timepoint: The beginning of the study and the end of the study. Method of measurement: Defecation booklet. Shahid Beheshti University of Medical Sciences Approved 2022-03-15 Research Ethics Committee School of Pharmacy and Nursing & Midwifery- Shahid Beheshti University of Central department of ministry of health and medical education, Simaye Iran st, Shahrak Ghods Tehran Tehran Iran (Islamic Republic of)