Parkinson’s patients sought for trial of small intestinal microbiome
Observational study in Canada now enrolling up to 75 patients, ages 50-85
An observational clinical trial in Canada that’s investigating the role of the small intestinal microbiome — the population of natural microorganisms living in the gastrointestinal tract — in Parkinson’s disease is now recruiting participants.
Its researchers specifically aim to determine if Parkinson’s patients carry a unique microbial and metabolic fingerprint detected in the small intestinal fluid and blood.
The trial (NCT06003608), being conducted at Calgary Parkinson’s Research Initiative (CaPRI), will enroll up to 100 participants. Among them will be as many as 75 people with idiopathic, or unknown cause, Parkinson’s, ages 50-85, and 25 age-matched healthy volunteers. Patients need to be on immediate-release levopoda for at least two months prior to their enrollment in the study.
The cross-sectional study, which looks at data at a single point in time, is being conducted by MRM Health, a clinical-stage biopharmaceutical company, in collaboration with Nimble Science and the University of Calgary in Canada.
“This observational study is expected to help generate novel hypotheses to potentially impact the pathophysiology [or impaired physiological processes] of Parkinson’s disease and provide disease modifying therapy,” Davide Martino, MD, PhD, from CaPRI and the trial’s principal investigator, said in a press release. “There is a high unmet medical need for safe and effective treatments for this seriously debilitating disease, and novel therapeutic modalities will be very welcomed by patients and caregivers, especially if they are disease modifying.”
Testing if Parkinson’s patients carry a unique microbial ‘fingerprint’
Trial participation will require an onsite visit at the CaPRI site in Calgary.
Each individual in the study will ingest two oral SIMBA capsules — SIMBA is short for small intestine microbiome aspiration — that are then recovered in patients’ stools while at home. A blood sample will be collected at the clinical site.
Developed and validated by Nimble Science, the SIMBA capsule system is a single-use, ingestible capsule that allows the sampling of small intestinal contents in a non-invasive manner. After leaving the acid content of the stomach and reaching the small intestine, the capsule opens and absorbs the intestinal content. Its content is sealed prior to passing the large intestine and released in the stools.
The SIMBA capsule was built to allow radiographic tracking of its passage throughout the gastrointestinal system.
The main goal of the study, expected to be completed later this year, is to assess the differences in the intestinal microbiome between Parkinson’s and healthy participants.
We expect that the data generated in this study will provide unique insights into the composition of the small intestinal microbiome, which is so far largely unexplored, and its connection to the pathophysiology [disease mechanisms] of Parkinson’s disease.
Additional goals include the comparison of blood metabolites between both groups, and how the small intestinal microbiome and blood metabolites correlate with levopoda treatment. Metabolites are small molecules produced during the chemical processes of metabolism in living organisms.
“We are emboldened to use our Small Intestine MicroBiome Aspiration (SIMBA) system to gather more data in order to better understand the role of the microbiome in the small intestine of Parkinson’s disease patients,” said Sabina Bruehlmann, CEO at Nimble Science.
MRM Health is developing a consortium of microbiome therapeutics based on well-characterized commensal or beneficial microbial strains using its proprietary CORAL technology. CORAL harnesses the power of computer analysis to select and optimize microbial strains that may tackle key disease-driving mechanisms with enhanced potency.
According to MRM Health, the company’s Good Manufacturing Practice (cGMP) platform allows for the production of the microbial therapeutics as a “single drug substance,” overcoming traditional limitations of microbiome therapy. cGMP are set to ensure that batches of a medicine are produced with consistent high quality.
Sam Possemiers, CEO at MRM Health, said the company was “excited to collaborate with Nimble Science and the Calgary Parkinson’s Research Initiative” to test the SIMBA capsule’s use “to sample the small intestinal content.”
“We expect that the data generated in this study will provide unique insights into the composition of the small intestinal microbiome, which is so far largely unexplored, and its connection to the pathophysiology [disease mechanisms] of Parkinson’s disease,” Possemiers said.
The results, Possemiers added, “will feed into our existing program and enable us to fine-tune and accelerate the development of novel live biotherapeutic products for the treatment of this progressive, neurodegenerative disease.”
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