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AzTrials

Parkinson DiseasePhase 1NCT03671785

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

A Phase 1 study testing PRIM-DJ2727 in people with Parkinson Disease, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 55 to 75 years
Conditions the study is for
Parkinson 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
15 participants
Where
1 siteUnited States
Study dates
15 May 2019to 12 Oct 2022
Phase
Phase 1
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 55 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

Other trials in United States

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 Twice Weekly Administration of Lyophilized PRIM-DJ2727 or Placebo Given Orally for 12 Weeks in Subjects With Parkinson's Disease

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

Being tested
PRIM-DJ2727, Placebo oral capsule
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-DJ2727Drug

    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 oral capsuleDrug

    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

Study groups in NCT03671785
Study groupRoleWhat they receive
Active group treated with healthy fecal microbiotaExperimentalNot described
Receives: Drug: PRIM-DJ2727
Placebo groupExperimentalNot described
Receives: Drug: Placebo oral capsule

What is being measured

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

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

    The Shannon diversity index is used to characterize species diversity in a community. Shannon's index accounts for both abundance and evenness of the species present. A high index value would represent a diverse and equally distributed community, and lower values represent a less diverse community. A value of 0 would represent a community with just one species. Typical values are generally between 1.5 and 3.5.

    Measured: baseline

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

    The Shannon diversity index is used to characterize species diversity in a community. Shannon's index accounts for both abundance and evenness of the species present. A high index value would represent a diverse and equally distributed community, and lower values represent a less diverse community. A value of 0 would represent a community with just one species. Typical values are generally between 1.5 and 3.5.

    Measured: week 6

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

    The Shannon diversity index is used to characterize species diversity in a community. Shannon's index accounts for both abundance and evenness of the species present. A high index value would represent a diverse and equally distributed community, and lower values represent a less diverse community. A value of 0 would represent a community with just one species. Typical values are generally between 1.5 and 3.5.

    Measured: week 13

  4. Microbiome Diversity in Fecal Samples as Indicated by the Shannon Diversity Index

    The Shannon diversity index is used to characterize species diversity in a community. Shannon's index accounts for both abundance and evenness of the species present. A high index value would represent a diverse and equally distributed community, and lower values represent a less diverse community. A value of 0 would represent a community with just one species. Typical values are generally between 1.5 and 3.5.

    Measured: month 4

  5. Microbiome Diversity in Fecal Samples as Indicated by the Shannon Diversity Index

    The Shannon diversity index is used to characterize species diversity in a community. Shannon's index accounts for both abundance and evenness of the species present. A high index value would represent a diverse and equally distributed community, and lower values represent a less diverse community. A value of 0 would represent a community with just one species. Typical values are generally between 1.5 and 3.5.

    Measured: month 6

  6. Microbiome Diversity in Fecal Samples as Indicated by the Shannon Diversity Index

    The Shannon diversity index is used to characterize species diversity in a community. Shannon's index accounts for both abundance and evenness of the species present. A high index value would represent a diverse and equally distributed community, and lower values represent a less diverse community. A value of 0 would represent a community with just one species. Typical values are generally between 1.5 and 3.5.

    Measured: month 9

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

    Measured: baseline

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

    Measured: week 6

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

    Measured: week 13

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

    Measured: month 4

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

    Measured: month 6

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

    Measured: month 9

  13. Any untoward medical occurrence after fecal microbiota transplantation (FMT)

    Measured: 9 months after treatments starts

Secondary outcomes (34)

  1. Number of participants with an increase in flora diversity in fecal samples

    Measured: 9 months after treatments starts

  2. Change in number of bowel movements per day

    The 2 week data point will be the average of bowel movements per day over the two weeks after initiation of treatment.

    Measured: Baseline, 2 weeks

  3. Motor function as characterized by Unified Parkinson's Disease Rating Scale (UPDRS) Total Score

    UPDRS is a disability and impairment scale for PD progression and consists of 4 sections; I: evaluation of mentation, behavior, and mood (13 questions) II: evaluation of activities of daily living including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food (13 questions) III: motor examination (33 scores based on 18 questions with right, left or other body distributions scores) IV: motor complications (6 questions)

    All items have 5 response options: 0 = normal, 1 = slight (symptoms/ signs with sufficiently low frequency or intensity to cause no impact on function), 2 = mild (symptoms/ signs of frequency or intensity sufficient to cause a modest impact on function, 3 = moderate (symptoms/ signs sufficiently frequent or intense to impact considerably, but not prevent function), 4 = severe (symptoms/ signs that prevent function).

    Total Score ranges from 0 to 260, with higher scores indicating a worse outcome.

    Measured: baseline

  4. Motor function as characterized by Unified Parkinson's Disease Rating Scale (UPDRS) Total Score

    UPDRS is a disability and impairment scale for PD progression and consists of 4 sections; I: evaluation of mentation, behavior, and mood (13 questions) II: evaluation of activities of daily living including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food (13 questions) III: motor examination (33 scores based on 18 questions with right, left or other body distributions scores) IV: motor complications (6 questions)

    All items have 5 response options: 0 = normal, 1 = slight (symptoms/ signs with sufficiently low frequency or intensity to cause no impact on function), 2 = mild (symptoms/ signs of frequency or intensity sufficient to cause a modest impact on function, 3 = moderate (symptoms/ signs sufficiently frequent or intense to impact considerably, but not prevent function), 4 = severe (symptoms/ signs that prevent function).

    Total Score ranges from 0 to 260, with higher scores indicating a worse outcome.

    Measured: 4 months

  5. Motor function as characterized by Unified Parkinson's Disease Rating Scale (UPDRS) Total Score

    UPDRS is a disability and impairment scale for PD progression and consists of 4 sections; I: evaluation of mentation, behavior, and mood (13 questions) II: evaluation of activities of daily living including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food (13 questions) III: motor examination (33 scores based on 18 questions with right, left or other body distributions scores) IV: motor complications (6 questions)

    All items have 5 response options: 0 = normal, 1 = slight (symptoms/ signs with sufficiently low frequency or intensity to cause no impact on function), 2 = mild (symptoms/ signs of frequency or intensity sufficient to cause a modest impact on function, 3 = moderate (symptoms/ signs sufficiently frequent or intense to impact considerably, but not prevent function), 4 = severe (symptoms/ signs that prevent function).

    Total Score ranges from 0 to 260, with higher scores indicating a worse outcome.

    Measured: 9 months

  6. Motor function as characterized by Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score

    UPDRS is a disability and impairment scale for PD progression and consists of 4 sections; I: evaluation of mentation, behavior, and mood (13 questions) II: evaluation of activities of daily living including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food (13 questions) III: motor examination (33 scores based on 18 questions with right, left or other body distributions scores) IV: motor complications (6 questions)

    All items have 5 response options: 0 = normal, 1 = slight (symptoms/ signs with sufficiently low frequency or intensity to cause no impact on function), 2 = mild (symptoms/ signs of frequency or intensity sufficient to cause a modest impact on function, 3 = moderate (symptoms/ signs sufficiently frequent or intense to impact considerably, but not prevent function), 4 = severe (symptoms/ signs that prevent function).

    Motor Score ranges from 0 to 156, with higher scores indicating a worse outcome.

    Measured: baseline

  7. Motor function as characterized by Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score

    UPDRS is a disability and impairment scale for PD progression and consists of 4 sections; I: evaluation of mentation, behavior, and mood (13 questions) II: evaluation of activities of daily living including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food (13 questions) III: motor examination (33 scores based on 18 questions with right, left or other body distributions scores) IV: motor complications (6 questions)

    All items have 5 response options: 0 = normal, 1 = slight (symptoms/ signs with sufficiently low frequency or intensity to cause no impact on function), 2 = mild (symptoms/ signs of frequency or intensity sufficient to cause a modest impact on function, 3 = moderate (symptoms/ signs sufficiently frequent or intense to impact considerably, but not prevent function), 4 = severe (symptoms/ signs that prevent function).

    Motor Score ranges from 0 to 156, with higher scores indicating a worse outcome.

    Measured: 4 months

  8. Motor function as characterized by Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score

    UPDRS is a disability and impairment scale for PD progression and consists of 4 sections; I: evaluation of mentation, behavior, and mood (13 questions) II: evaluation of activities of daily living including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food (13 questions) III: motor examination (33 scores based on 18 questions with right, left or other body distributions scores) IV: motor complications (6 questions)

    All items have 5 response options: 0 = normal, 1 = slight (symptoms/ signs with sufficiently low frequency or intensity to cause no impact on function), 2 = mild (symptoms/ signs of frequency or intensity sufficient to cause a modest impact on function, 3 = moderate (symptoms/ signs sufficiently frequent or intense to impact considerably, but not prevent function), 4 = severe (symptoms/ signs that prevent function).

    Motor Score ranges from 0 to 156, with higher scores indicating a worse outcome.

    Measured: 9 months

  9. Parkinson's disease symptoms as assessed by the Modified Hoehn and Yahr Scale

    Modified H\&Y scale will be used as a staging instrument to monitor progression of PD's symptoms. It defines broad categories of motor function in PD starting at Stage 0: no signs of disease to the highest stage 5: wheelchair bound or bedridden unless aided.

    Measured: baseline

  10. Parkinson's disease symptoms as assessed by the Modified Hoehn and Yahr Scale

    Modified H\&Y scale will be used as a staging instrument to monitor progression of PD's symptoms. It defines broad categories of motor function in PD starting at Stage 0: no signs of disease to the highest stage 5: wheelchair bound or bedridden unless aided.

    Measured: 4 months

  11. Parkinson's disease symptoms as assessed by the Modified Hoehn and Yahr Scale

    Modified H\&Y scale will be used as a staging instrument to monitor progression of PD's symptoms. It defines broad categories of motor function in PD starting at Stage 0: no signs of disease to the highest stage 5: wheelchair bound or bedridden unless aided.

    Measured: 9 months

  12. Cognitive domains characterized by using Montreal Cognitive Assessment

    MoCA is a rapid screening instrument for mild cognitive dysfunction. It assess different cognitive domains: attention and concentration, executive functions, memory, language, visuo-constructional skills, conceptual thinking, calculations, and orientation. The total score ranges from 0 to 30; a score of 26 or above is considered normal. MoCA will be performed at the enrollment for baseline and the clinic visit on 9 month for study endpoint assessment, and early termination visit (if applicable).

    Measured: baseline

  13. Cognitive domains characterized by using Montreal Cognitive Assessment

    MoCA is a rapid screening instrument for mild cognitive dysfunction. It assess different cognitive domains: attention and concentration, executive functions, memory, language, visuo-constructional skills, conceptual thinking, calculations, and orientation. The total score ranges from 0 to 30; a score of 26 or above is considered normal. MoCA will be performed at the enrollment for baseline and the clinic visit on 9 month for study endpoint assessment, and early termination visit (if applicable).

    Measured: 4 months

  14. Cognitive domains characterized by using Montreal Cognitive Assessment

    MoCA is a rapid screening instrument for mild cognitive dysfunction. It assess different cognitive domains: attention and concentration, executive functions, memory, language, visuo-constructional skills, conceptual thinking, calculations, and orientation. The total score ranges from 0 to 30; a score of 26 or above is considered normal. MoCA will be performed at the enrollment for baseline and the clinic visit on 9 month for study endpoint assessment, and early termination visit (if applicable).

    Measured: 9 months

  15. Change in Sense of Smell as assessed by the University of Pennsylvania Smell Identification Test (UPSIT)

    The UPSIT is a comprehensive 40-item self-administered olfactory test that provides an absolute indication of smell loss (anosmia; mild, moderate or severe microsomia). The range of scores is 0 to 40, and a higher score indicates better olfaction

    Measured: baseline, 9 months

  16. Qualify of life as assessed by the Parkinson's disease Questionnaire (PDQ-39)

    The Parkinson's disease Questionnaire (PDQ-39) is a 39 questions self-completed questionnaire that comprises 8 domains: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognition (4 items), communication (3 items) and bodily discomfort (3 items). All items are assumed to impact Quality of Life (QoL) and must be answered to compute scores for each dimension. Questions are answered based on experiences from the preceding month using a 5-point ordinal scoring system: 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, 4 = always. Overall score ranges from 0 = never have difficulty to 100 = always have difficulty. For each of the 8 domains, the domain score is the sum of scores in the domain divided by the maximum possible score of all items in the domain, multiplied by 100. The overall score is the sum of all 8 domain scores divided by 8.

    Measured: baseline

  17. Qualify of life as assessed by the Parkinson's disease Questionnaire (PDQ-39)

    The Parkinson's disease Questionnaire (PDQ-39) is a 39 questions self-completed questionnaire that comprises 8 domains: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognition (4 items), communication (3 items) and bodily discomfort (3 items). All items are assumed to impact QoL and must be answered to compute scores for each dimension. Questions are answered based on experiences from the preceding month using a 5-point ordinal scoring system: 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, 4 = always. Overall score ranges from 0 = never have difficulty to 100 = always have difficulty. For each of the 8 domains, the domain score is the sum of scores in the domain divided by the maximum possible score of all items in the domain, multiplied by 100. The overall score is the sum of all 8 domain scores divided by 8.

    Measured: 4 months

  18. Qualify of life as assessed by the Parkinson's disease Questionnaire (PDQ-39)

    The Parkinson's disease Questionnaire (PDQ-39) is a 39 questions self-completed questionnaire that comprises 8 domains: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognition (4 items), communication (3 items) and bodily discomfort (3 items). All items are assumed to impact QoL and must be answered to compute scores for each dimension. Questions are answered based on experiences from the preceding month using a 5-point ordinal scoring system: 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, 4 = always. Overall score ranges from 0 = never have difficulty to 100 = always have difficulty. For each of the 8 domains, the domain score is the sum of scores in the domain divided by the maximum possible score of all items in the domain, multiplied by 100. The overall score is the sum of all 8 domain scores divided by 8.

    Measured: 9 months

  19. Quality of Life as assessed by the Parkinson Disease Non-Motor Symptoms (PD NMS) Questionnaire

    The range of scores is 0 to 30. A score of under 10 is mild, 10-20 moderate and over 20 severe.

    Measured: baseline

  20. Quality of Life as assessed by the Parkinson Disease Non-Motor Symptoms (PD NMS) Questionnaire

    The range of scores is 0 to 30. A score of under 10 is mild, 10-20 moderate and over 20 severe.

    Measured: 4 months

  21. Quality of Life as assessed by the Parkinson Disease Non-Motor Symptoms (PD NMS) Questionnaire

    The range of scores is 0 to 30. A score of under 10 is mild, 10-20 moderate and over 20 severe.

    Measured: 9 months

  22. Number of participants who changed required PD symptomatic therapy after treatment

    Measured: 9 months after treatment

  23. Number of participants with worsening of PD symptoms or other potential microbial-mediated disorders

    Measured: 9 months after treatment

  24. Anxiety as assessed by the Parkinson Anxiety Scale (PAS)

    The Parkinson Anxiety Scale (PAS) is an anxiety measure scale for use in PD patients. This is a 12-item observer or patient-rated scale with three subscales, for persistent and episodic anxiety, and avoidance behavior. Items are scored on a 5-point Likert scale, with '0' meaning 'not or never' and '4' meaning 'severe or almost always'. Total score ranges from 0 to 48, with higher scores indicating worse outcomes.

    Measured: baseline

  25. Anxiety as assessed by the Parkinson Anxiety Scale (PAS)

    The Parkinson Anxiety Scale (PAS) is an anxiety measure scale for use in PD patients. This is a 12-item observer or patient-rated scale with three subscales, for persistent and episodic anxiety, and avoidance behavior. Items are scored on a 5-point Likert scale, with '0' meaning 'not or never' and '4' meaning 'severe or almost always'. Total score ranges from 0 to 48, with higher scores indicating worse outcomes.

    Measured: 4 months

  26. Anxiety as assessed by the Parkinson Anxiety Scale (PAS)

    The Parkinson Anxiety Scale (PAS) is an anxiety measure scale for use in PD patients. This is a 12-item observer or patient-rated scale with three subscales, for persistent and episodic anxiety, and avoidance behavior. Items are scored on a 5-point Likert scale, with '0' meaning 'not or never' and '4' meaning 'severe or almost always'. Total score ranges from 0 to 48, with higher scores indicating worse outcomes.

    Measured: 9 months

  27. Depression as assessed by the Geriatric Depression Scale Short form (GDS-SF)

    The Geriatric Depression Scale Short form (GDS-SF) is 15-item screening tool that is used to identify depression in older adults. The total score is 0 to 15, with a score of 5 or greater suggesting depression.

    Measured: baseline

  28. Depression as assessed by the Geriatric Depression Scale Short form (GDS-SF)

    The Geriatric Depression Scale Short form (GDS-SF) is 15-item screening tool that is used to identify depression in older adults.The total score is 0 to 15, with a score of 5 or greater suggesting depression.

    Measured: 4 months

  29. Depression as assessed by the Geriatric Depression Scale Short form (GDS-SF)

    The Geriatric Depression Scale Short form (GDS-SF) is 15-item screening tool that is used to identify depression in older adults.The total score is 0 to 15, with a score of 5 or greater suggesting depression.

    Measured: 9 months

  30. Change in gastric emptying time (GET) as assessed by the Smart Pill® (SP) Wireless pH/pressure recording capsule

    Smart Pill will be used to assess gastrointestinal dysmotility in PD patients before and after 12- week treatment. Smart Pill will be administered first during the run-In period clinic visit and again at Week 13 clinic visit following the completion of 12-week treatment. After an overnight fast, subjects will ingest the Smart Pill capsule with a nutrient bar (Smart Bar, 243 kcal) and will be instructed to wear a data receiver for 5 days or until the expulsion of the Smart Pill. After expulsion of the Smart Pill in approximately 5 days, subject will return the data receiver. Data receiver can either be dropped by or mailed via FedEx to the study site. Changes in gastric emptying time (GET), small bowel transit time (SBTT), colon transit time (CTT), small/ large bowel transit time (SLBTT) and whole gut transit time (WGTT) will be assessed by parameters established by the company providing the Smart Pill capsule.

    Measured: baseline, 13 weeks

  31. Change in small bowel transit time (SBTT) as assessed by the Smart Pill® (SP) Wireless pH/pressure recording capsule

    Smart Pill will be used to assess gastrointestinal dysmotility in PD patients before and after 12- week treatment. Smart Pill will be administered first during the run-In period clinic visit and again at Week 13 clinic visit following the completion of 12-week treatment. After an overnight fast, subjects will ingest the Smart Pill capsule with a nutrient bar (Smart Bar, 243 kcal) and will be instructed to wear a data receiver for 5 days or until the expulsion of the Smart Pill. After expulsion of the Smart Pill in approximately 5 days, subject will return the data receiver. Data receiver can either be dropped by or mailed via FedEx to the study site. Changes in gastric emptying time (GET), small bowel transit time (SBTT), colon transit time (CTT), small/ large bowel transit time (SLBTT) and whole gut transit time (WGTT) will be assessed by parameters established by the company providing the Smart Pill capsule.

    Measured: baseline, 13 weeks

  32. Change in colon transit time (CTT) as assessed by the Smart Pill® (SP) Wireless pH/pressure recording capsule

    Smart Pill will be used to assess gastrointestinal dysmotility in PD patients before and after 12- week treatment. Smart Pill will be administered first during the run-In period clinic visit and again at Week 13 clinic visit following the completion of 12-week treatment. After an overnight fast, subjects will ingest the Smart Pill capsule with a nutrient bar (Smart Bar, 243 kcal) and will be instructed to wear a data receiver for 5 days or until the expulsion of the Smart Pill. After expulsion of the Smart Pill in approximately 5 days, subject will return the data receiver. Data receiver can either be dropped by or mailed via FedEx to the study site. Changes in gastric emptying time (GET), small bowel transit time (SBTT), colon transit time (CTT), small/ large bowel transit time (SLBTT) and whole gut transit time (WGTT) will be assessed by parameters established by the company providing the Smart Pill capsule.

    Measured: baseline, 13 weeks

  33. Change in small/large bowel transit time (SLBTT) as assessed by the Smart Pill® (SP) Wireless pH/pressure recording capsule

    Smart Pill will be used to assess gastrointestinal dysmotility in PD patients before and after 12- week treatment. Smart Pill will be administered first during the run-In period clinic visit and again at Week 13 clinic visit following the completion of 12-week treatment. After an overnight fast, subjects will ingest the Smart Pill capsule with a nutrient bar (Smart Bar, 243 kcal) and will be instructed to wear a data receiver for 5 days or until the expulsion of the Smart Pill. After expulsion of the Smart Pill in approximately 5 days, subject will return the data receiver. Data receiver can either be dropped by or mailed via FedEx to the study site. Changes in gastric emptying time (GET), small bowel transit time (SBTT), colon transit time (CTT), small/ large bowel transit time (SLBTT) and whole gut transit time (WGTT) will be assessed by parameters established by the company providing the Smart Pill capsule.

    Measured: baseline, 13 weeks

  34. Change in whole gut transit time (WGTT) as assessed by the Smart Pill® (SP) Wireless pH/pressure recording capsule

    Smart Pill will be used to assess gastrointestinal dysmotility in PD patients before and after 12- week treatment. Smart Pill will be administered first during the run-In period clinic visit and again at Week 13 clinic visit following the completion of 12-week treatment. After an overnight fast, subjects will ingest the Smart Pill capsule with a nutrient bar (Smart Bar, 243 kcal) and will be instructed to wear a data receiver for 5 days or until the expulsion of the Smart Pill. After expulsion of the Smart Pill in approximately 5 days, subject will return the data receiver. Data receiver can either be dropped by or mailed via FedEx to the study site. Changes in gastric emptying time (GET), small bowel transit time (SBTT), colon transit time (CTT), small/ large bowel transit time (SLBTT) and whole gut transit time (WGTT) will be assessed by parameters established by the company providing the Smart Pill capsule.

    Measured: baseline, 13 weeks

Timeline

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

  1. First posted14 Sep 2018
  2. Study start15 May 2019
  3. Primary completion9 Oct 2022
  4. Study completion12 Oct 2022

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03671785
Sponsor's protocol ID
HSC-SPH-18-0621
Status last verified
May 2023
First submitted
12 Sep 2018
Last updated
24 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36937520

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PRIM-DJ2727 in people with Parkinson Disease, run by The University of Texas Health Science Center, Houston at 1 site in United States.

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 9 inclusion and 15 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: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this 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.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 as Indicated by the Shannon Diversity Index (time frame: baseline). The study lists 13 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 NCT03671785, which also lists 1 linked publication.

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 24 May 2023.

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