None listed
Conditions
Brief summary
Parkinson’s disease is a neurological condition that results in degeneration of nerve cells in a particular part of the brain that produce the chemical dopamine. The exact cause of Parkinson’s disease is not yet known, however there is some evidence that the gut may be involved. Faecal Microbiota Transplant (FMT) involves delivering a stool sample from a healthy individual (“donor”), to the bowel of the person taking part in the study (“recipient”). The aim of this study is to determine whether FMT is tolerated in individuals with Parkinson's disease and to evaluate for side effects, if any. This treatment is already TGA approved and used in many other conditions. We also aim to evaluate if FMT can improve motor function in patients with Parkinson’s disease, for example tremor, walking, stiffness and slowness. We also aim to determine whether FMT improves constipation or quality of life in Parkinson’s disease. We will also examine the stool of participants over the course of the study to see how the stool make-up changes after receiving the transplant. Participants will receive infusions of placebo or FMT via a gastrointestinal tube and then swap over after the first two infusions. Participants will not know what infusion they are receiving. This is a pilot study, which means it is a small study to test whether FMT might work but it is not yet an established treatment for Parkinson’s disease.
Interventions
Double blind randomised placebo cross over trial of faecal microbiota transplantation (FMT)
The study is a comparison of an experimental treatment (FMT) against placebo
The placebo arm will cross-over to treatment arm (FMT) after two placebo treatments and an assessment period
To maintain blinding, the treatment arm (FMT) will receive two placebo infusions after active treatment and an assessment period.
The 1st and 2nd infusions (FMT or placebo) will occur 2 weeks apart.
Following a 4 week
Double blind randomised placebo cross over trial of faecal microbiota transplantation (FMT) The study is a comparison of an experimental treatment (FMT) against placebo The placebo arm will cross-over to treatment arm (FMT) after two placebo treatments and an assessment period To maintain blinding, the treatment arm (FMT) will receive two placebo infusions after active treatment and an assessment period. The 1st and 2nd infusions (FMT or placebo) will occur 2 weeks apart. Following a 4 week gap participants will then cross over. The 3rd and 4th infusions (FMT or placebo) will also occur 2 weeks apart. Assessments will then occur at 4 weeks, 3 months and 6 months. Each participant will receive FMT from one single donor, which will remain the same for both treatment visits. A total of three donors will be used in the trial. The FMT used will be TGA-approved BiomeBoost. Each treatment/placebo is 100ml and will be infused via Peg-J tube at a rate of 400ml/hr. FMT/placebo will be administered a total of 100ml of FMT via two 50ml syringes and a pump will ensure the above rate. The infusions will take place in the outpatient department under the supervision of the investigating team (nursing and medical supervision and monitoring). No intervention is required at home following the infusion but participants will contact the investigating team should they experience adverse effects, prompting medical review. Assessments will occur at each visit Assessments will include motor and non-motor Parkinson's disease rating scales.
Sponsors
Westmead Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with a clinical diagnosis of idiopathic Parkinson disease at time of referral, who are currently receiving levodopa/carbidopa intestinal gel (LCIG) via percutaneous endoscopic jejunostomy tube (either 16 or 24 hours per day) Patients with >/= 3 hours of OFF time (defined as anything other than best ON) Cognitive capacity to provide their own consent, based on clinical judgement of investigator stable LCIG infusion rate for past 4 weeks
Exclusion criteria
• Any patient who declines to participate in the study. • The patient has a clinical diagnosis of an atypical Parkinsonism at the time of referral. • Any patient with a diagnosis of inflammatory bowel disease or Clostridium difficile infection • Any patient who has been on LCIG for less than 4 months • Any patient who has received antibiotics within 6 weeks from enrolment date • Any patient who has consumed probiotics within 6 weeks from enrolment date. There are no other specific dietary restrictions during the study. • Any patient who has required a change in LCIG infusion rate in the past 4 weeks • Life-threatening food allergies, e.g. nut allergy. • Pregnancy or lactation. • Contraindication to preferred means of administration, e.g. oesophageal stricture limiting nasogastric tube insertion. • Patients with decompensated cirrhosis, uncontrolled HIV (CD4 count < 240 cells/mm3), recent bone marrow transplant (within past 6 weeks), or other significant immunodeficiency. • Patients taking major immunosuppressive agents, including high dose corticosteroids (e.g. prednisolone = 60 mg/day), calcineurin inhibitors, mTOR inhibitors, lymphocyte-depleting biologic agents, anti-TNF therapy, and recent use of chemotherapeutic anti-neoplastic agents (past 6 weeks).
Outcome results
None listed