RecruitingPHASE2INTERVENTIONAL

Probiotic Treatment for Depression and Associated Mood Disorders in Parkinson's Disease

This study is exploring if a specific blend of 'good bacteria', called a probiotic, can help reduce symptoms of depression in people living with Parkinson's disease. Many people with Parkinson's also experience depression, which can make life harder, and there's a growing belief that our gut bacteria might play a role in both conditions. The study will involve about 60 participants who will randomly receive either the probiotic supplement or a placebo (a dummy pill) for 12 weeks. Scientists want to see if changing the gut bacteria can improve mood. This project could lead to new ways to support the well-being of people with Parkinson's.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University of British Columbia

Enrolment target

Start

20 Jan 2025

Estimated completion

31 Dec 2027

Parkinson Disease Depression PARKINSON DISEASE (Disorder)

What is this study about?

Parkinson's disease is a condition that affects movement, but it can also cause other problems, including feelings of sadness, low mood, and depression. In fact, about one-third of people with Parkinson's experience depression, which can significantly impact their quality of life and even make daily tasks more challenging. Interestingly, people with Parkinson's also very often have tummy troubles, like constipation, and there's a growing idea that our gut health and the types of bacteria living in our tummy might be connected to our brain and our mood.

This study wants to find out if taking a special supplement called a probiotic, which contains 'good bacteria', can help improve depression in people with Parkinson's. Probiotics have shown some promise in helping with mood in other groups of people, and there's a strong belief that the mixture of bacteria in our gut (called the gut microbiome) is linked to Parkinson's itself. By giving participants either a probiotic or a dummy pill (placebo) for 12 weeks, the researchers hope to understand if improving gut health can lead to better mood.

The findings from this study could be really important. If the probiotic helps, it could offer a new and simple way to support people with Parkinson's who are struggling with depression, potentially improving their overall well-being and daily life.

Key takeaways

This study explores a probiotic for depression in Parkinson's.
It aims to understand if gut bacteria can improve mood.
Participants take either a probiotic or a dummy pill for 12 weeks.
It helps science, with potential personal mood benefits.
Participation is voluntary, you can leave anytime.

Who may be eligible?

This study is looking for volunteers with Parkinson's disease, specifically those who are between 40 and 80 years old. You should have a mild to moderate form of Parkinson's and also be experiencing mild to moderate depression. It's important that you can speak English.

There are certain reasons why you might not be able to join. For example, if you have a different type of Parkinson's, are having thoughts of harming yourself, or have severe depression, this study may not be suitable. Also, if you've recently used other probiotics, antibiotics, or certain natural supplements for depression, or if your Parkinson's or depression medications have changed recently, you might not be able to take part. Researchers also can't include people with severe memory problems or other serious neurological conditions.

If you are a woman who could become pregnant, you would need to agree to use reliable birth control methods during the study and have negative pregnancy test results.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I have Parkinson's disease and am 40-80 years old.
I have mild to moderate Parkinson's and mild to moderate depression.
I have NOT used other probiotics or antibiotics in the last 3 months (yogurt is okay).
My depression or Parkinson's medications haven't changed in the last 4 weeks (or 2 weeks for Parkinson's meds).
I don't have severe memory problems or another serious brain condition.
If I am a woman who could become pregnant, I will use effective birth control.

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly placed into one of two groups: one group will receive a probiotic supplement, and the other will receive a placebo (an inactive dummy pill). You won't know which one you are taking, and neither will the study team. You'll take your assigned supplement daily for 12 weeks.

Throughout these 12 weeks, you'll have regular visits or check-ups with the study team. During these visits, they will assess your mood, Parkinson's symptoms, and general health. You'll also need to keep your usual daily activities and current medications the same unless your doctor advises otherwise.

The total duration of your active involvement in the study, including the treatment period and follow-up assessments, will last for 12 weeks.

Potential risks and benefits

Taking part in this study may offer some potential benefits, such as a possible improvement in your mood and depression symptoms if the probiotic is effective. It also gives you the chance to contribute to scientific knowledge that could help many other people with Parkinson's disease in the future. However, there are no guarantees of direct personal benefit. Potential risks are generally low, as probiotics are usually well-tolerated, but like any supplement, there's always a small chance of mild stomach upset. You might also experience no change in your symptoms. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Pacific Parkinson's Research Centre
Verified postcode
Vancouver, Canada· Recruiting

Common questions

What is a probiotic?

A probiotic is a supplement containing 'good bacteria' that are believed to have health benefits, especially for your gut and digestion.

What is a placebo?

A placebo is a 'dummy pill' that looks exactly like the real treatment but contains no active ingredient. It helps researchers fairly compare the effects of the actual treatment.

Will I know if I'm taking the probiotic or the placebo?

No, this is a 'triple-blinded' study, meaning you, the researchers, and the people analysing the data won't know who is receiving which treatment until the study is over.

How long will I be in the study?

You will take the supplement for 12 weeks, and your total participation in the study will last for this period.

What if my health changes during the study?

You should always discuss any changes in your health or medications with your regular doctor and the study team immediately.

How to find out more

Matthew Leung, BSc

matthew.leung@ubc.ca 604-827-1905 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.