Clinical trial NCT03671785: Study of the Fecal Microbiome in Patients With Parkinson's Disease
Official title: A Prospective, Randomized, Placebo-Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Twice Weekly Administration of Lyophilized PRIM-DJ2727 or Placebo Given Orally for 12 Weeks in Subjects With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson Disease
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Kelsey Research Foundation
First posted: 2018-09-14
Enrollment: 15
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to characterize the intestinal microbiome in subjects with Parkinson's disease and to determine safety and trends in improvements in diversity of colonic microbiome following administration of lyophilized PRIM-DJ2727


Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of Parkinson's Disease (PD) for less than or equal to 10 years based on the United Kingdom Brain Bank Criteria and the Modified Hoehn-Yahr (H\&Y) staging system of less than 3 in the "OFF medicine" state of at least 8-12 hours (subjects should have an asymmetric and unilateral symptoms onset).
* Mild microsomia to anosmia (The University of Pennsylvania Smell Identification Test (UPSIT) less than 33), which is supportive of idiopathic PD.
* Robust response to dopaminergic therapy (defined as greater than 33% reduction in symptoms (on the Unified Parkinson's Disease Rating Scale part III (UPDRS-III)) when measured in the ON medicine state compared to OFF state.
* Subject has a history of constipation.
* Sexually active male and female subjects of child-bearing potential agree to use an effective method of birth control during the study.
* Female subjects of child-bearing potential must have a negative urine Qualitative Human chorionic gonadotropin (hCG) pregnancy test at enrollment and on the Week 1, Day 1 of the Treatment prior to administration of study drug.
* Willing and able to sign an informed consent form and attend study assessments and follow ups.
* Subject has an attending physician who will provide non-transplant care for the subject.
* Subject is able to maintain a stable Parkinson's therapy medical regimen during participation in the study.

Exclusion Criteria:

* Unable to take multiple capsules orally.
* Montreal Cognitive Assessment (MoCA) Score less than or equal to 23.
* Atypical, vascular or drug-induced Parkinsonism.
* Clinical features of psychosis or refractory hallucinations.
* Unstable Parkinson's disease symptomatic therapy (defined as recent changes or additions to the PD regimen).
* Compromised immune system (e.g. primary immune disorders or clinical immunosuppression due to a medical condition or medication e.g. taking systemic steroids greater than 20 milligrams (mg) a day or prednisone-equivalent)
* Receipt of systemic non-topical antibiotic therapy currently or within 14 days of enrollment.
* Prior Deep Brain Stimulation, or surgical intervention for PD, intravenous glutathione therapy or stem cell therapy.
* History of medium or large vessel cerebrovascular accidents.
* History of use of an investigational drug within 90 days prior to the screening visit.
* Positive results for human immunodeficiency virus (HIV) or Hepatitis B / C.
* Current history for active states of Inflammatory bowel disease, Irritable bowel syndrome, microscopic colitis, celiac disease, short gut syndrome, colostomy, colectomy, gastrointestinal fistulae or strictures.
* History of significant uncontrolled systemic disease that in the opinion of the study investigator could interfere with study participation and/or objectives.
* Life expectancy of less than 1 year.
* In the opinion of investigator, subject for any reason, should be excluded from the study

Primary outcomes:
measure: Microbiome Diversity in Fecal Samples as Indicated by the Shannon Diversity Index
timeFrame: baseline
measure: Microbiome Diversity in Fecal Samples as Indicated by the Shannon Diversity Index
timeFrame: week 6
measure: Microbiome Diversity in Fecal Samples as Indicated by the Shannon Diversity Index
timeFrame: week 13
measure: Microbiome Diversity in Fecal Samples as Indicated by the Shannon Diversity Index
timeFrame: month 4
measure: Microbiome Diversity in Fecal Samples as Indicated by the Shannon Diversity Index
timeFrame: month 6
measure: Microbiome Diversity in Fecal Samples as Indicated by the Shannon Diversity Index
timeFrame: month 9
measure: Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant
timeFrame: baseline
measure: Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant
timeFrame: week 6
measure: Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant
timeFrame: week 13
measure: Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant
timeFrame: month 4
measure: Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant
timeFrame: month 6
measure: Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant
timeFrame: month 9
measure: Any untoward medical occurrence after fecal microbiota transplantation (FMT)
timeFrame: 9 months after treatments starts
Secondary outcomes:
measure: Number of participants with an increase in flora diversity in fecal samples
timeFrame: 9 months after treatments starts
measure: Change in number of bowel movements per day
timeFrame: Baseline, 2 weeks
measure: Motor function as characterized by Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
timeFrame: baseline
measure: Motor function as characterized by Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
timeFrame: 4 months
measure: Motor function as characterized by Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
timeFrame: 9 months
measure: Motor function as characterized by Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score
timeFrame: baseline
measure: Motor function as characterized by Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score
timeFrame: 4 months
measure: Motor function as characterized by Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score
timeFrame: 9 months
measure: Parkinson's disease symptoms as assessed by the Modified Hoehn and Yahr Scale
timeFrame: baseline
measure: Parkinson's disease symptoms as assessed by the Modified Hoehn and Yahr Scale
timeFrame: 4 months
measure: Parkinson's disease symptoms as assessed by the Modified Hoehn and Yahr Scale
timeFrame: 9 months
measure: Cognitive domains characterized by using Montreal Cognitive Assessment
timeFrame: baseline
measure: Cognitive domains characterized by using Montreal Cognitive Assessment
timeFrame: 4 months
measure: Cognitive domains characterized by using Montreal Cognitive Assessment
timeFrame: 9 months
measure: Change in Sense of Smell as assessed by the University of Pennsylvania Smell Identification Test (UPSIT)
timeFrame: baseline, 9 months
measure: Qualify of life as assessed by the Parkinson's disease Questionnaire (PDQ-39)
timeFrame: baseline
measure: Qualify of life as assessed by the Parkinson's disease Questionnaire (PDQ-39)
timeFrame: 4 months
measure: Qualify of life as assessed by the Parkinson's disease Questionnaire (PDQ-39)
timeFrame: 9 months
measure: Quality of Life as assessed by the Parkinson Disease Non-Motor Symptoms (PD NMS) Questionnaire
timeFrame: baseline
measure: Quality of Life as assessed by the Parkinson Disease Non-Motor Symptoms (PD NMS) Questionnaire
timeFrame: 4 months
measure: Quality of Life as assessed by the Parkinson Disease Non-Motor Symptoms (PD NMS) Questionnaire
timeFrame: 9 months
measure: Number of participants who changed required PD symptomatic therapy after treatment
timeFrame: 9 months after treatment
measure: Number of participants with worsening of PD symptoms or other potential microbial-mediated disorders
timeFrame: 9 months after treatment
measure: Anxiety as assessed by the Parkinson Anxiety Scale (PAS)
timeFrame: baseline
measure: Anxiety as assessed by the Parkinson Anxiety Scale (PAS)
timeFrame: 4 months
measure: Anxiety as assessed by the Parkinson Anxiety Scale (PAS)
timeFrame: 9 months
measure: Depression as assessed by the Geriatric Depression Scale Short form (GDS-SF)
timeFrame: baseline
measure: Depression as assessed by the Geriatric Depression Scale Short form (GDS-SF)
timeFrame: 4 months
measure: Depression as assessed by the Geriatric Depression Scale Short form (GDS-SF)
timeFrame: 9 months
measure: Change in gastric emptying time (GET) as assessed by the Smart Pill® (SP) Wireless pH/pressure recording capsule
timeFrame: baseline, 13 weeks
measure: Change in small bowel transit time (SBTT) as assessed by the Smart Pill® (SP) Wireless pH/pressure recording capsule
timeFrame: baseline, 13 weeks
measure: Change in colon transit time (CTT) as assessed by the Smart Pill® (SP) Wireless pH/pressure recording capsule
timeFrame: baseline, 13 weeks
measure: Change in small/large bowel transit time (SLBTT) as assessed by the Smart Pill® (SP) Wireless pH/pressure recording capsule
timeFrame: baseline, 13 weeks
measure: Change in whole gut transit time (WGTT) as assessed by the Smart Pill® (SP) Wireless pH/pressure recording capsule
timeFrame: baseline, 13 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: University of Texas Health Science Center School of Public Health
name: Herbert L DuPont, MD
role: PRINCIPAL_INVESTIGATOR
References: