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

NCT ID: NCT03671785

Last Updated: 2023-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-15
• Study Completion Date: 2022-10-12

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

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active group treated with healthy fecal microbiota

Group Type: EXPERIMENTAL

PRIM-DJ2727

Intervention Type: DRUG

Twice filtered fecal microbiota product from three screened healthy donors will be lyophilized and encapsulated in enteric-coated capsules. Each dose of enteric coated capsules consists of 60 grams of stool and will be administered orally twice-weekly for 12 consecutive weeks

Placebo group

Group Type: EXPERIMENTAL

Placebo oral capsule

Intervention Type: DRUG

Placebo capsule will be identical to PRIM-DJ2727 but will not contain intestinal bacteria. The placebo will consist of Lactose (spray-dried United States Pharmacopeia (USP) 64.385gm), food color, powdered Black, Brown, and Yellow in the enteric capsules. Placebo will be administered orally twice-weekly for 12 consecutive weeks

Interventions

PRIM-DJ2727

Twice filtered fecal microbiota product from three screened healthy donors will be lyophilized and encapsulated in enteric-coated capsules. Each dose of enteric coated capsules consists of 60 grams of stool and will be administered orally twice-weekly for 12 consecutive weeks

Intervention Type: DRUG

Placebo oral capsule

Placebo capsule will be identical to PRIM-DJ2727 but will not contain intestinal bacteria. The placebo will consist of Lactose (spray-dried United States Pharmacopeia (USP) 64.385gm), food color, powdered Black, Brown, and Yellow in the enteric capsules. Placebo will be administered orally twice-weekly for 12 consecutive weeks

Intervention Type: DRUG

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kelsey Research Foundation

OTHER

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Herbert DuPont, MD

Professor of Infectious Diseases

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Herbert L DuPont, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center School of Public Health

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

References

DuPont HL, Suescun J, Jiang ZD, Brown EL, Essigmann HT, Alexander AS, DuPont AW, Iqbal T, Utay NS, Newmark M, Schiess MC. Fecal microbiota transplantation in Parkinson's disease-A randomized repeat-dose, placebo-controlled clinical pilot study. Front Neurol. 2023 Mar 2;14:1104759. doi: 10.3389/fneur.2023.1104759. eCollection 2023.

Reference Type: DERIVED

PMID: 36937520 (View on PubMed)

Other Identifiers

HSC-SPH-18-0621

Identifier Type: -

Identifier Source: org_study_id