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WithdrawnNCT03026231Updated Aug 10, 2018

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

A Phase 1/2 interventional study of PRIM-DJ2727 and Placebo (for PRIM-DJ2727) in Parkinson's Disease, sponsored by The University of Texas Health Science Center, Houston. Withdrawn. Open to participants aged 45 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-08-10.

Sponsored by The University of Texas Health Science Center, Houston · Phase 1/2, Interventional, and Treatment

Why this study was withdrawn
study will be started under a new modified protocol
Phase
Phase 1/2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
45 Years to 70 Years
Sex
All
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Study 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.

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Conditions studied

  • Parkinson's Disease

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Keywords

  • Fecal microbiota transplantation
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

Browse Parkinson Disease studies →

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    PRIM-DJ2727

    Subjects with PD will be randomly assigned to receive PRIM-DJ2727 in orally administered enteric-coated capsules

    Biological: PRIM-DJ2727

  • Placebo comparator
    Placebo

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

    Drug: Placebo (for PRIM-DJ2727)

Interventions

  • BiologicalPRIM-DJ2727

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

  • DrugPlacebo (for PRIM-DJ2727)

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

06

What researchers measure

Primary outcomes

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

    Time frame: 3 years

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

    Time frame: 6 months

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

    Time frame: 12 months

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

    Time frame: 3 years

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

    Time frame: 6 months

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

    Time frame: 12 months

  7. Most abundant Phylum in Fecal Sample

    Time frame: 3 years

  8. Most abundant Phylum in Fecal Sample

    Time frame: 6 months

  9. Most abundant Phylum in Fecal Sample

    Time frame: 12 months

Secondary outcomes

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

    Time frame: 3 years

  2. Number of bowel movements per day

    Time frame: 3 years

  3. Number of bowel movements per day

    Time frame: 6 months

  4. Number of bowel movements per day

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 12 months

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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 12 months

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

    Time frame: 3 years

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

    Time frame: day 1 of treatment

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

    Time frame: 6 months

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

    Time frame: 12 months

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

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03026231
Lead sponsor
The University of Texas Health Science Center, Houston
Collaborators
Kelsey Research Foundation
Responsible party
Herbert DuPont (Professor of Medicine, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Jan 20, 2017
Start date
Jul 15, 2017 (estimated)
Primary completion
Jul 17, 2018
Completion
Jul 17, 2018
Last update
Aug 10, 2018

Study contacts

Herbert L DuPont, MD
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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