Efficacy of Probiotics for Parkinson Disease (PD)

Changhua Christian Medical Foundation

Status: Withdrawn

Conditions: Movement Disorders; Depression; Anxiety; Parkinson's Disease (PD)

Treatments: Dietary Supplement: Placebo; Dietary Supplement: probiotics

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06118294

230723

Details and patient eligibility

About

In previous clinical studies, PS128 has been reported to ameliorate motor deficits in Parkinson's disease (PD). PS23 has been reported to delay some age-related disorders.

On the basis of previous animal and clinical studies which hope that this study can support the theory of the gut-brain axis, and have the opportunity to realize the relationship between peripheral inflammation and neurodegeneration.

Full description

The gut microbiota plays important roles in gastrointestinal homeostasis, essential physiological processes and CNS function, and affects the gut-brain axis via neural, immune and endocrine pathways giving rise to the microbiota-gut-brain-axis (MGBA). Combining the MGBA concept and the theory that Parkinson's disease (PD) is derived in the gut, researchers have studied the relationship between the gut microbiota and the PD neurodegenerative process. Probiotics are live microorganisms that confer health benefits on the host and can improve host physical and mental health by affecting MGBA homeostasis. Lactobacillus plantarum PS128 (PS128) and Lactobacillus paracasei PS23 (PS23) are specific probiotics, known as a psychobiotic, which has been demonstrated to alleviate depression- and anxiety-like behaviors in mouse model. Furthermore, PS128 alleviated motor deficits, nigrostriatal dopaminergic neuronal cell death, and striatal dopamine reduction in the MPTP mouse model of Parkinson's disease. In previous clinical studies, PS128 has been reported to ameliorate motor deficits in PD. PS23 has been reported to delay some age-related disorders.

On the basis of previous animal and clinical studies which hope that this study can support the theory of the gut-brain axis, and have the opportunity to realize the relationship between peripheral inflammation and neurodegeneration.

The eligible participants will be administered with probiotics capsules for 12 weeks. Symptoms of PD will be clinically evaluated before and after the treatment. Blood and stool samples will be collected before and after the intervention for biochemical parameters.

Sex: All

Ages: 41 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The age between 41-80 years old and at least the elementary education level.
• Diagnosed as a patient with Parkinson's disease of modified Hoehn and Yahr Stage between 1 and 3 as rated.

Exclusion criteria

• Diagnosed before 40 years old.
• Used probiotic products in powder, capsule, or tablet form within four weeks.
• Have taken antibiotics within four weeks.
• Those who are not suitable to participate in the research are judged by PI.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

0 participants in 2 patient groups, including a placebo group

Probiotics

Experimental group

Description:

daily ingestion of 2 capsules of probiotics (\>30 billion CFU/capsule)

Treatment:

Dietary Supplement: probiotics

Placebo

Placebo Comparator group

Description:

daily ingestion of 2 capsules which only contained 425 ± 25 mg microcrystalline cellulose

Treatment:

Dietary Supplement: Placebo