Probiotics for Depression in Parkinson's Disease
(ProD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a multi-strain probiotic (helpful bacteria) can reduce depression in people with Parkinson's disease. Participants will receive either the probiotic treatment or a placebo (a non-active substance) for 12 weeks. It suits individuals with a confirmed Parkinson's diagnosis who experience mild to moderate depression and haven't recently changed their medications. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
A previous study found that probiotic treatments were safe and well-tolerated by people with Parkinson's Disease. Research shows that these probiotics often help manage symptoms without causing major side effects. Another study found that probiotics improved symptoms in Parkinson's patients, with few negative effects reported. Overall, the evidence suggests that probiotics are safe for use in Parkinson's Disease, making them a promising option for further research.12345
Why do researchers think this study treatment might be promising for depression in Parkinson's Disease?
Unlike the standard treatments for depression in Parkinson's disease, which often involve medications like antidepressants, this probiotic-based approach offers a new avenue by targeting gut health. Researchers are excited because probiotics like Ecologic® BARRIER 849 might influence the gut-brain axis, potentially improving mood by altering gut bacteria. This treatment is unique as it provides a natural, non-pharmaceutical option that could complement or even reduce the need for traditional medication, offering a fresh perspective on managing depression in Parkinson's patients.
What evidence suggests that this probiotic is effective for treating depression in Parkinson's Disease?
This trial will compare the effects of probiotics and a placebo on depression in individuals with Parkinson's disease. Research has shown that probiotics might alleviate depression, including in those with Parkinson’s disease. Some studies found that certain probiotics can improve both movement and mood issues in Parkinson's patients. This effect may occur because probiotics influence the gut-brain connection, potentially reducing gut inflammation. Probiotics have also been associated with improved mood in various groups, not just those with Parkinson's. Overall, early research suggests that probiotics could offer a promising approach to managing depression related to Parkinson’s disease.16789
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a 12-week multi-strain probiotic or placebo intervention
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- Probiotic
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Ecologic® BARRIER 849 (Maize starch, maltodextrin, vegetable protein, potassium chloride, +/- probiotic bacteria (B. bifidum W23, B. lactis W51, B. lactis W52, L. acidophilus W37, L. brevis W63, L. casei W56, L. salivarius W24, Lc. lactis W19, Lc. lactis W58; ≥ 2,5\*10\^9 colony forming unit (CFU)/g), magnesium sulphate, manganese sulphate.) sachet, two times daily dosing for a total of 2 grams (viable cell count of 2.5 × 10\^9 CFU/gram) per day.
Placebo (maize starch, maltodextrin, vegetable protein, magnesium sulphate, manganese sulphate)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of British Columbia
Lead Sponsor
Citations
Probiotics for the treatment of depression and its comorbidities
An emerging body of evidence suggests possible antidepressant effects resulting from probiotic supplementation, which can normalize depression-associated ...
2.
neurologylive.com
neurologylive.com/view/phase-2-controlled-trial-tests-potential-probiotics-parkinson-related-depression-mood-disordersPhase 2 Controlled Trial Tests Potential of Probiotics in ...
A new phase 2 trial explores probiotics' potential to alleviate depression and mood disorders in patients with Parkinson disease, linking gut ...
Probiotic supplementation for anxiety symptoms in people ...
The probiotic group showed a statistically significant improvement on the Montreal Cognitive Assessment compared with placebo (adjusted mean ...
Efficacy of probiotic supplements on Parkinson's disease
Studies have shown that probiotics can effectively prevent and improve PD symptoms via the gut-brain axis, and its potential mechanisms include regulating ...
Therapeutic role of probiotics in motor and non- ...
Regarding probiotic supplementation, several human and in vivo studies have shown it to improve motor function and non-motor symptoms (e.g., constipation, ...
Advice to People with Parkinson's in My Clinic: Probiotics and ...
There is increasing evidence that microbial-based therapies can be useful in people with Parkinson's disease (PD).
Effects of Probiotics on Peripheral Immunity in Parkinson's ...
Probiotics May Have Beneficial Effects in Parkinson's Disease: In vitro Evidence. Front Immunol. 2019 May 7;10:969. doi: 10.3389/fimmu.2019.00969 ...
The Impact of Probiotics on Clinical Symptoms and ...
Our data suggest that probiotics may modulate peripheral cytokines levels and improve clinical symptoms in PD patients.
Probiotics and the Treatment of Parkinson's Disease: An Update
Multiple lines of evidence show that probiotics control and improve several motor and non-motor symptoms in patients and experimental animal models of PD.
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