Evaluating the Efficacy of Probiotics in Constipation & Motor Dysfunctions in patients with Idiopathic Parkinson Disease

Evaluating the effect of probiotics on constipation and movement disorders caused by Parkinson's disease

A single center, randomized, blinded controlled trial on 30 patients in two parallel groups.

Imam Hossein Hospital Neurology Clinic by recording the number of bowel movements, ease of bowel movements, stool consistency, and UPDRS before intervention. At the beginning of the study, the patient will be provided with a booklet to record the number of defecation, ease of defecation, and fecal consistency. At the end of the eight-week study, the booklets will be collected to review and analyze the data. The medicine and placebo will be packed in look-alike box. Researchers include physicians, nurses, outcome assessors, quality control expert, and data analyzers are blinded.

Inclusion Criteria: Parkinson's Disease and Rome IV criteria for functional constipation - age equal to or >60. Exclusion Criteria: Any history of hypersensitivity reaction or contraindications of probiotic use, Active infections, Treated with antibiotics, Immunocompromised patients.

Patients will be divided into intervention and control groups. Both groups will be given brochures, nutritional training, and non-pharmacological strategies. The intervention group will take a capsule containing probiotic and the control group a look-alike placebo capsule.

Changes in motor/non-motor symptoms of Parkinson's disease, quality of life, number of bowel movements, stool consistency, feeling of complete bowel movement, adverse drug reactions and number of pharmacotherapic interventions for constipation

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.

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.

potentially the whole data will be published after participants become unidentified.

The data will be available 6 months after data publish.

Industrial and Academic Researchers

To carry out further research

Dr. Hadi Esmaily, School of Pharmacy, Shahid Beheshti University of Medical Sciences.

It will be available through an email to corresponding author