Study of the Fecal Microbiome in Patients With Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 5 June 2023
• Main ID: NCT03671785
• Date of registration: 12/09/2018
• Prospective Registration: Yes
• Primary sponsor: The University of Texas Health Science Center, Houston
• Public title: Study of the Fecal Microbiome in Patients With Parkinson's Disease
• Scientific 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
• Date of first enrolment: May 15, 2019
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03671785
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Herbert L DuPont, MD
• Affiliation: University of Texas Health Science Center School of Public Health

Key inclusion & exclusion 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



Age minimum: 55 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: Placebo oral capsule

Drug: PRIM-DJ2727

Primary Outcome(s)

Microbiome Diversity in Fecal Samples as Indicated by the Shannon Diversity Index [Time Frame: baseline]

Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant [Time Frame: week 6]

Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant [Time Frame: month 4]

Microbiome Diversity in Fecal Samples as Indicated by the Shannon Diversity Index [Time Frame: month 4]

Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant [Time Frame: month 9]

Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant [Time Frame: week 13]

Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant [Time Frame: month 6]

Any untoward medical occurrence after fecal microbiota transplantation (FMT) [Time Frame: 9 months after treatments starts]

Microbiome Diversity in Fecal Samples as Indicated by the Shannon Diversity Index [Time Frame: month 6]

Microbiome Diversity in Fecal Samples as Indicated by the Shannon Diversity Index [Time Frame: month 9]

Microbiome Diversity in Fecal Samples as Indicated by the Shannon Diversity Index [Time Frame: week 6]

Microbiome Diversity in Fecal Samples as Indicated by the Shannon Diversity Index [Time Frame: week 13]

Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant [Time Frame: baseline]

Secondary Outcome(s)

Change in colon transit time (CTT) as assessed by the Smart Pill® (SP) Wireless pH/pressure recording capsule [Time Frame: baseline, 13 weeks]

Change in gastric emptying time (GET) as assessed by the Smart Pill® (SP) Wireless pH/pressure recording capsule [Time Frame: baseline, 13 weeks]

Anxiety as assessed by the Parkinson Anxiety Scale (PAS) [Time Frame: 9 months]

Change in small bowel transit time (SBTT) as assessed by the Smart Pill® (SP) Wireless pH/pressure recording capsule [Time Frame: baseline, 13 weeks]

Change in Sense of Smell as assessed by the University of Pennsylvania Smell Identification Test (UPSIT) [Time Frame: baseline, 9 months]

Cognitive domains characterized by using Montreal Cognitive Assessment [Time Frame: baseline]

Depression as assessed by the Geriatric Depression Scale Short form (GDS-SF) [Time Frame: baseline]

Motor function as characterized by Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score [Time Frame: 9 months]

Number of participants with worsening of PD symptoms or other potential microbial-mediated disorders [Time Frame: 9 months after treatment]

Motor function as characterized by Unified Parkinson's Disease Rating Scale (UPDRS) Total Score [Time Frame: 9 months]

Qualify of life as assessed by the Parkinson's disease Questionnaire (PDQ-39) [Time Frame: 4 months]

Anxiety as assessed by the Parkinson Anxiety Scale (PAS) [Time Frame: baseline]

Depression as assessed by the Geriatric Depression Scale Short form (GDS-SF) [Time Frame: 4 months]

Parkinson's disease symptoms as assessed by the Modified Hoehn and Yahr Scale [Time Frame: 9 months]

Quality of Life as assessed by the Parkinson Disease Non-Motor Symptoms (PD NMS) Questionnaire [Time Frame: 4 months]

Qualify of life as assessed by the Parkinson's disease Questionnaire (PDQ-39) [Time Frame: 9 months]

Quality of Life as assessed by the Parkinson Disease Non-Motor Symptoms (PD NMS) Questionnaire [Time Frame: baseline]

Motor function as characterized by Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score [Time Frame: 4 months]

Cognitive domains characterized by using Montreal Cognitive Assessment [Time Frame: 4 months]

Motor function as characterized by Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score [Time Frame: baseline]

Number of participants with an increase in flora diversity in fecal samples [Time Frame: 9 months after treatments starts]

Qualify of life as assessed by the Parkinson's disease Questionnaire (PDQ-39) [Time Frame: baseline]

Anxiety as assessed by the Parkinson Anxiety Scale (PAS) [Time Frame: 4 months]

Cognitive domains characterized by using Montreal Cognitive Assessment [Time Frame: 9 months]

Change in number of bowel movements per day [Time Frame: Baseline, 2 weeks]

Change in small/large bowel transit time (SLBTT) as assessed by the Smart Pill® (SP) Wireless pH/pressure recording capsule [Time Frame: baseline, 13 weeks]

Change in whole gut transit time (WGTT) as assessed by the Smart Pill® (SP) Wireless pH/pressure recording capsule [Time Frame: baseline, 13 weeks]

Depression as assessed by the Geriatric Depression Scale Short form (GDS-SF) [Time Frame: 9 months]

Motor function as characterized by Unified Parkinson's Disease Rating Scale (UPDRS) Total Score [Time Frame: baseline]

Number of participants who changed required PD symptomatic therapy after treatment [Time Frame: 9 months after treatment]

Motor function as characterized by Unified Parkinson's Disease Rating Scale (UPDRS) Total Score [Time Frame: 4 months]

Parkinson's disease symptoms as assessed by the Modified Hoehn and Yahr Scale [Time Frame: 4 months]

Quality of Life as assessed by the Parkinson Disease Non-Motor Symptoms (PD NMS) Questionnaire [Time Frame: 9 months]

Parkinson's disease symptoms as assessed by the Modified Hoehn and Yahr Scale [Time Frame: baseline]

Secondary ID(s)

HSC-SPH-18-0621

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Kelsey Research Foundation