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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03026231
Date of registration:	11/01/2017
Prospective Registration:	Yes
Primary sponsor:	The University of Texas Health Science Center, Houston
Public title:	Characterization of Fecal Microbiome Changes After Administration of PRIM-DJ2727 in Parkinson's Disease Patients
Scientific title:	A Prospective, Randomized Placebo Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Weekly Administration of Lyophilized PRIM-DJ2727 Given Orally in Subjects With Parkinson's Disease
Date of first enrolment:	July 15, 2017
Target sample size:	0
Recruitment status:	Withdrawn
URL:	https://clinicaltrials.gov/show/NCT03026231
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
Phase:	Phase 1/Phase 2

Countries of recruitment
United States

Contacts

Name:	Herbert L DuPont, MD
Address:
Telephone:
Email:
Affiliation:	The University of Texas Health Science Center, Houston

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis PD with a Hoehn and Yahr stage of < 3 in the "Off medicine" state

- Sexually active male and female subjects of child-bearing potential must agree to use
an effective method of birth control during the treatment and follow-up period

- Female subjects of child-bearing potential must have a negative pregnancy test in the
72 hours before the procedure

- Subject willing to sign an informed consent form

- Subject deemed likely to survive for = 1 year after enrolment

- Subject's attending physician will refer and provide non-transplant care for the
subject

- Subjects must demonstrate adherence to and the ability to maintain a Parkinson's
therapy medical regimen that is stable for 90 days before enrolment and participation
in the study.

Exclusion Criteria:

- Greater than 20 grams of ethanol intake daily

- Unstable Parkinson's disease

- Other immune disorder or clinical immunosuppression

- Probiotic used during study period

- Severe underlying disease such that the subject is not expected to survive for one or
more years or unstable medical condition requiring frequent change in treatments

- Current or recent within one month receipt of an antibiotic with expected activity
against enteric bacteria

- Prior Deep Brain Stimulation, or surgical intervention for PD , intravenous
glutathione therapy or stem cell therapy

- HIV or Hepatitis B / C positive

Age minimum: 45 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: Placebo (for PRIM-DJ2727)

Biological: PRIM-DJ2727

Primary Outcome(s)

Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant [Time Frame: 3 years]

Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant [Time Frame: 12 months]

Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index [Time Frame: 3 years]

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

Most abundant Phylum in Fecal Sample [Time Frame: 3 years]

Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index [Time Frame: 12 months]

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

Most abundant Phylum in Fecal Sample [Time Frame: 12 months]

Most abundant Phylum in Fecal Sample [Time Frame: 6 months]

Secondary Outcome(s)

Memory as assessed by score on the Montreal Cognitive Assessment (MoCA) [Time Frame: 3 years]

Memory as assessed by score on the Montreal Cognitive Assessment (MoCA) [Time Frame: day 1 of treatment]

Subject assessment of global improvement in PD and quality of life as indicated by score the self-survey Parkinson's Disease Questionnaire 39 (PDQ-39) [Time Frame: 3 years]

Subject assessment of global improvement in PD and quality of life as indicated by score the self-survey Parkinson's Disease Questionnaire 39 (PDQ-39) [Time Frame: day 1 of treatment]

Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [Time Frame: 3 years]

Memory as assessed by score on the Montreal Cognitive Assessment (MoCA) [Time Frame: 12 months]

Memory as assessed by score on the Montreal Cognitive Assessment (MoCA) [Time Frame: 6 months]

Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [Time Frame: 12 months]

Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [Time Frame: 6 months]

Subject assessment of global improvement in PD and quality of life as indicated by score the self-survey Parkinson's Disease Questionnaire 39 (PDQ-39) [Time Frame: 12 months]

Subject assessment of global improvement in PD and quality of life as indicated by score the self-survey Parkinson's Disease Questionnaire 39 (PDQ-39) [Time Frame: 6 months]

Improvements in flora diversity by oral administration of a fecal suspension from healthy donors comparing data with untreated controls [Time Frame: 3 years]

Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [Time Frame: 1 day]

Number of bowel movements per day [Time Frame: 3 years]

Number of participants with a change in required anti-PD symptomatic or levodopa therapy [Time Frame: 12 months]

Number of participants with worsening of PD symptoms or other potential flora-mediated disorders as indicated by patient diares [Time Frame: 12 months]

Number of bowel movements per day [Time Frame: 12 months]

Number of bowel movements per day [Time Frame: 6 months]

Secondary ID(s)

UT-SPH/KRF FMT-2016-PD-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Kelsey Research Foundation

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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