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Parkinson's DiseasePhase 1/2NCT03026231

Characterization of Fecal Microbiome Changes After Administration of PRIM-DJ2727 in Parkinson's Disease Patients

A Phase 1/2 study testing PRIM-DJ2727 in people with Parkinson's Disease, run by The University of Texas Health Science Center, Houston.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to characterize the intestinal flora in subjects with Parkinson's Disease (PD) and to determine safety and trends in improvements in diversity of colonic microbiome following fecal microbiota transplantation. Read more about this study

Who is it for?
Ages 45 to 70 years
Conditions the study is for
Parkinson's Disease
What is being tested?
PRIM-DJ2727
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
15 Jul 2017to 17 Jul 2018
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

About this study

Official 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

The purpose of this study is to characterize the intestinal flora in subjects with Parkinson's Disease (PD) and to determine safety and trends in improvements in diversity of colonic microbiome following fecal microbiota transplantation.

Being tested
PRIM-DJ2727, Placebo (for PRIM-DJ2727)
Keywords
Fecal microbiota transplantation
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRIM-DJ2727Biological

    Thirty eligible subjects with PD will be randomly assigned to receive either PRIM-DJ2727 in orally administered enteric-coated capsules or placebo capsules

  • Placebo (for PRIM-DJ2727)Drug

    Thirty eligible subjects with PD will be randomly assigned to receive placebo capsules

Study groups in NCT03026231
Study groupRoleWhat they receive
PRIM-DJ2727Active comparatorSubjects with PD will be randomly assigned to receive PRIM-DJ2727 in orally administered enteric-coated capsules
Receives: Biological: PRIM-DJ2727
PlaceboPlacebo comparatorThirty eligible subjects with PD will be randomly assigned to receive placebo capsules
Receives: Drug: Placebo (for PRIM-DJ2727)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index

    Measured: 3 years

  2. Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index

    Measured: 6 months

  3. Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index

    Measured: 12 months

  4. Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant

    Measured: 3 years

  5. Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant

    Measured: 6 months

  6. Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant

    Measured: 12 months

  7. Most abundant Phylum in Fecal Sample

    Measured: 3 years

  8. Most abundant Phylum in Fecal Sample

    Measured: 6 months

  9. Most abundant Phylum in Fecal Sample

    Measured: 12 months

Secondary outcomes (18)

  1. Improvements in flora diversity by oral administration of a fecal suspension from healthy donors comparing data with untreated controls

    Measured: 3 years

  2. Number of bowel movements per day

    Measured: 3 years

  3. Number of bowel movements per day

    Measured: 6 months

  4. Number of bowel movements per day

    Measured: 12 months

  5. Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

    The (MDS-UPDRS) measures mentation, behaviour, mood, activities of daily living and motor manifestations and the Montreal Cognitive Assessment (MoCA) for memory assessment.

    Measured: 3 years

  6. Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

    The (MDS-UPDRS) measures mentation, behaviour, mood, activities of daily living and motor manifestations and the Montreal Cognitive Assessment (MoCA) for memory assessment.

    Measured: 1 day

  7. Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

    The (MDS-UPDRS) measures mentation, behaviour, mood, activities of daily living and motor manifestations and the Montreal Cognitive Assessment (MoCA) for memory assessment.

    Measured: 6 months

  8. Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

    The (MDS-UPDRS) measures mentation, behaviour, mood, activities of daily living and motor manifestations and the Montreal Cognitive Assessment (MoCA) for memory assessment.

    Measured: 12 months

  9. Number of participants with a change in required anti-PD symptomatic or levodopa therapy

    Measured: 12 months

  10. 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)

    Measured: 3 years

  11. 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)

    Measured: day 1 of treatment

  12. 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)

    Measured: 6 months

  13. 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)

    Measured: 12 months

  14. Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)

    Measured: 3 years

  15. Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)

    Measured: day 1 of treatment

  16. Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)

    Measured: 6 months

  17. Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)

    Measured: 12 months

  18. Number of participants with worsening of PD symptoms or other potential flora-mediated disorders as indicated by patient diares

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2017 (estimated)
  2. Study start15 Jul 2017 (estimated)
  3. Primary completion17 Jul 2018
  4. Study completion17 Jul 2018

Why it stopped: study will be started under a new modified protocol

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03026231
Sponsor's protocol ID
UT-SPH/KRF FMT-2016-PD-01
Status last verified
Aug 2018
First submitted
11 Jan 2017
Last updated
10 Aug 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Borody TJ, Paramsothy S, Agrawal G. Fecal microbiota transplantation: indications, methods, evidence, and future directions. Curr Gastroenterol Rep. 2013 Aug;15(8):337. doi: 10.1007/s11894-013-0337-1.

    PubMed 23852569

  • Fasano A, Bove F, Gabrielli M, Petracca M, Zocco MA, Ragazzoni E, Barbaro F, Piano C, Fortuna S, Tortora A, Di Giacopo R, Campanale M, Gigante G, Lauritano EC, Navarra P, Marconi S, Gasbarrini A, Bentivoglio AR. The role of small intestinal bacterial overgrowth in Parkinson's disease. Mov Disord. 2013 Aug;28(9):1241-9. doi: 10.1002/mds.25522. Epub 2013 May 27.

    PubMed 23712625

  • Nakane S, Yoshioka M, Oda N, Tani T, Chida K, Suzuki M, Funakawa I, Inukai A, Hasegawa K, Kuroda K, Mizoguchi K, Shioya K, Sonoda Y, Matsuo H. The characteristics of camptocormia in patients with Parkinson's disease: A large cross-sectional multicenter study in Japan. J Neurol Sci. 2015 Nov 15;358(1-2):299-303. doi: 10.1016/j.jns.2015.09.015. Epub 2015 Sep 8.

    PubMed 26428310

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PRIM-DJ2727 in people with Parkinson's Disease, run by The University of Texas Health Science Center, Houston.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index (time frame: 3 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03026231, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018.

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