Giovani Schulte Farina
Harvard T. H Chan School of Public Health - ECPE - PPCR Program, Boston, MA, USA
Lauren Nirta
1. Harvard T. H Chan School of Public Health - ECPE - PPCR Program, Boston, MA, USA 2. MediSpeak Communications, Busan, South Korea
Lilia Maria Lima de Oliveira
Harvard T. H Chan School of Public Health - ECPE - PPCR Program, Boston, MA, USA
Jose Luis Chamba Rospigliosi
Harvard T. H Chan School of Public Health - ECPE - PPCR Program, Boston, MA, USA
Celso Francisco Pimentel Vespasiano
1. Harvard T. H Chan School of Public Health - ECPE - PPCR Program, Boston, MA, USA 2. Adium SA, São Paulo, SP, Brazil
Naira Link Woilte
Harvard T. H Chan School of Public Health - ECPE - PPCR Program, Boston, MA, USA
Ibrahim Antonio Radi Zahran
Harvard T. H Chan School of Public Health - ECPE - PPCR Program, Boston, MA, USA
Mariana Checo
1. Harvard T. H Chan School of Public Health - ECPE - PPCR Program, Boston, MA, USA 2. Asociación Dominicana Pro - Bienestar de la Familia Inc., Santo Domingo, Dominican Republic
Karen Barros Parron Fernandes
1. Harvard T. H Chan School of Public Health - ECPE - PPCR Program, Boston, MA, USA 2. School of Medicine, Pontifical Catholic University of Parana (PUCPR), Londrina, PR, Brazil 3. Département des Sciences de la Santé, Centre Intersectoriel en Santé D urable, Laboratoire de recherche BioNR, Université du Québec à Chicoutimi (UQAC), Saguenay, Québec, Canada
Dmitrii Blinov
Harvard T. H Chan School of Public Health - ECPE - PPCR Program, Boston, MA, USA
Rosario Caruso
1. Harvard T. H Chan School of Public Health - ECPE - PPCR Program, Boston, MA, USA2. Clinical Research Service, IRCCS Policlinico San Donato, San Donato Milanese, Italy 3. Department of Biomedical Sciences for Health, University of Milan, Milan, Italy
Aimee Michelle Mercado Dominguez
Harvard T. H Chan School of Public Health - ECPE - PPCR Program, Boston, MA, USA
Natalia Lorena Zamalloa Masias
Harvard T. H Chan School of Public Health - ECPE - PPCR Program, Boston, MA, USA
Joyce Meza-Venegas
Harvard T. H Chan School of Public Health - ECPE - PPCR Program, Boston, MA, USA
Ibrahim Saeed Ibrahim Mohamed
Harvard T. H Chan School of Public Health - ECPE - PPCR Program, Boston, MA, USA
Takuro Nishizawa
Harvard T. H Chan School of Public Health - ECPE - PPCR Program, Boston, MA, USA
Angelica Valeria Jaldin Pinto
Harvard T. H Chan School of Public Health - ECPE - PPCR Program, Boston, MA, USA
Prakrity Urja
Harvard T. H Chan School of Public Health - ECPE - PPCR Program, Boston, MA, USA
Rodrigo Areán-Sanz
Harvard T. H Chan School of Public Health - ECPE - PPCR Program, Boston, MA, USA
Denise Saretta Schwartz
1. Harvard T. H Chan School of Public Health - ECPE - PPCR Program, Boston, MA, USA2. Professor Doctor at the School of Veterinary Medicine and Animal Science (FMVZ), University of São Paulo (USP), São Paulo, Brazil
Arturo Tamayo
1. Harvard T. H Chan School of Public Health - ECPE - PPCR Program, Boston, MA, USA2. Assistant Professor of Neurology and Cerebrovascular Diseases. The Max Rady Faculty of Health Sciences . University of Manitoba. Winnipeg, Canada
Abstract
Introduction: Parkinson’s disease (PD) is the second most prevalent degenerative neurological disorder globally. Comorbid major depressive disorder (MDD) is a common occurrence which adds considerably to disease burden. This protocol presents a study designed to investigate the effect of add-on probiotic supplementation on MDD in patients with PD.
Methods: We designed a phase IIb, randomized, triple-blind, placebo-controlled study to evaluate the efficacy and safety of probiotics as an adjuvant treatment to selective serotonin reuptake inhibitors (SSRI) for patients with mild to moderate PD and MDD.Participants will be randomized to probiotics (n=62) or placebo (n=62) arms using a permuted block randomization approach. Co-primary outcomes include changes in Montgomery-Åsberg Depression Rating Scale (MADRS) scores and SSRI equivalent doses, which will be compared between groups using a bivariate joint model. Secondary outcomes will include changes in both Beck Depression Inventory-II (BDI-II) score and levodopa dose, which will be analyzed using t-tests or Mann-Whitney tests as appropriate. Concurrent validity between MADRS and BDI-II will be assessed usingPearson’s or Spearman’s correlation tests. Safety will be evaluated by comparing discontinuation rates and adverse events between groups using chi-square. Data will be analyzed using intention-to-treat and per-protocol analyses, and missing data will be addressed using multiple imputation methods.
Discussion: Probiotics represent a potential new approach to managing depression inpatients with PD by targeting the gut-brain axis. The results will offer crucial information about the safety and efficacy of a low-cost and readily available supplement that mayalleviatedepression in this vulnerable population.
