Clinical Evaluation of the Antidepressant Effect of the Use of Probiotics in Bipolar Disorder and Possible Mediating Effects of Systemic and Intestinal Inflammatory Markers in the Microbiota
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Bipolar Disorder (BD) is highly incapacitating and associated with premature mortality. Depressive symptoms and episodes are the most frequent cause of disability in subjects with BD and over half of patients do not respond adequately to approved treatments for this condition, showing the need for new classes of treatments to complement current pharmacotherapy. Previous studies demonstrated that the intestinal flora have potential positive or negative effects on the Central Nervous System and suggest that adding specific strains of bacteria to people's diet may have antidepressant properties.The study proposes to evaluate the clinical benefit of adding probiotics to pharmacological treatments for bipolar depression. This will be a study with 84 subjects (42 receiving probiotics and 42 placebo). The research team in this department has focused especially on non-pharmacological treatments for bipolar disorder (psychotherapy, nutrition and exercise) and is multidisciplinary in scope with psychiatrists, psychologists, nurses, physiotherapists and nutritionists participating in research projects.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• BD type I or type II, according to the use of Mini Internacional Neuropsychiatric Interview (MINI)
• Score on the Young Mania Rating Scale (YMRS) \< 8
• Score on the Montgomery-Asberg Depression Rating Scale (MADRS) \> 8
• Be receiving major guideline-approved treatments for bipolar depression for at least 4 weeks
Locations
Other Locations
Brazil
University of Sao Paulo
RECRUITING
São Paulo
Contact Information
Primary
Adiel Rios, MD
adiel.rios@usp.br
5511945084970
Time Frame
Start Date:2023-01-09
Estimated Completion Date:2024-12-30
Participants
Target number of participants:84
Treatments
Experimental: Probiotic group
In addition to the usual medication treatment for bipolar disorder, following the main international guidelines for the treatment of bipolar disorder, subjects will receive food supplementation with a probiotic formulation, twice daily, with food. We will use Pendulum Therapeutics' Glucose Control, probiotic formulation patented in the United States.~Probiotic Ingredients: Clostridium butyricum WB-STR-0006, Clostridium beijerinckii WB-STR-0005, Anaerobutyricum hallii WB-STR-0008, Akkermansia muciniphila WB-STR-0001, and Bifidobacterium infantis.~The product also contains: Chicory inulin and oligofructose (prebiotic fiber), hypromellose (vegetarian capsule), fruit \& vegetable juice (coloring agent), magnesium stearate and silica (flow agent for encapsulation)
Placebo_comparator: Placebo Group
In addition to the usual medication treatment for bipolar disorder, following the main international guidelines for the treatment of bipolar disorder, the subjects will receive food supplementation with a placebo formulation, twice daily, with food We will use Pendulum Therapeutics' placebo formulation that contains:~Chicory inulin and oligofructose (prebiotic fiber), hypromellose (vegetarian capsule), fruit \& vegetable juice (coloring agent), magnesium stearate and silica (flow agent for encapsulation)