SYM-PD
Research type
Research Study
Full title
Efficacy of an oral probiotic (Symprove) on motor and non-motor symptoms in Parkinson’s disease: a novel randomised, double-blind, placebo-controlled study
IRAS ID
252293
Contact name
Kallol Ray Chaudhuri
Contact email
Duration of Study in the UK
1 years, 10 months, 17 days
Research summary
Recent studies have shown that the intestinal microbiota (bacteria that protect us from absorbing harmful products we ingest and maintain our "gut health") can be abnormal with a deficiency of several species of protective bacteria in people with Parkinson's (PwP). This leads to a “leaky-gut” that can absorb harmful material from the gut to the brain via the vagus nerve (gut-brain axis) and even lead to inflammation as well as abnormal alpha-synuclein (deposited protein in Parkinson’s) formation and deposition. Recently faecal transplantation has been proposed as a possible treatment strategy in PwP although the process needs many regulatory approvals and safety checks.
Symprove is an oral probiotic, which unlike other commercially probiotics, can reach the lower gut and it can improve symptoms in gastrointestinal conditions. From an audit at King’s College Hospital some PwP have showed an improvement of their symptoms after intake of Symprove. The rationale behind this observation may rest with Symprove inducing improvement in the gut microbiota. However, there are no studies which have addressed a possible beneficial effect of Symprove in PwP to date.
We propose a randomised, double-blind, placebo-controlled study involving 60 PwP suffering from constipation. Participants will be randomised into two arms (1:1 ratio): 70 ml Symprove versus 70 ml placebo (inactive liquid), taken orally once a day, for three months. Clinical outcomes such as non-motor symptoms, motor symptoms and quality of life will be measured using validated scales, questionnaires and wearable sensor recordings (Parkinson’s KinetiGraph, Smart Belt). Furthermore, blood tests for systemic inflammation markers and gut microbiome analysis will be performed. Assessment will be performed at baseline and at the end of the treatment (3 month +/- 1 week).
REC name
London - Surrey Research Ethics Committee
REC reference
19/LO/0319
Date of REC Opinion
8 May 2019
REC opinion
Further Information Favourable Opinion