Parkinson's Disease AggravatedPhase 1NCT04730245
Microbiota Modification for the Treatment of Motor Complication of Parkinson´s Disease
A Phase 1 study testing sodium phosphate enema, oral rifaximin and polyethylene glycol in people with Parkinson's Disease Aggravated, run by Torre Médica Santé at 1 site in Mexico.
Trial summary
In recent years, abnormalities in gut microbiota have been identified in patients with Parkinson´s disease having a possible role in motor manifestations. Among 80 patients with PD, we selected 14 with LID and motor fluctuations with limited response to pharmacological therapy to receive treatment with sodium… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease Aggravated
- What is being tested?
- sodium phosphate enema, oral rifaximin and polyethylene glycol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jun 2018to 30 Mar 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged 18-years old or older with moderate to severe dyskinesia and/or motor fluctuations with incomplete or poor response to adjustments in time and dose of levodopa and other anti-parkinsonian agents such as entacapone, rasagiline, dopamine receptor agonists and amantadine in 1-2 months prior to enrollment; defined by a Movement Disorders Society Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) part IV score equal or higher than 8 following pharmacological adjustments.
Who cannot join
- patients with chronic renal failure, decompensated heart failure, colonic abnormalities precluding the use of evacuating enema, known allergies to prescribed medications to reduce microbiota load and patients who declined to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Targeting Gut Microbiota for Motor Complications in Parkinson´s Disease
In recent years, abnormalities in gut microbiota have been identified in patients with Parkinson´s disease having a possible role in motor manifestations. Among 80 patients with PD, we selected 14 with LID and motor fluctuations with limited response to pharmacological therapy to receive treatment with sodium phosphate enema, oral rifaximin and polyethylene glycol to improve motor complications.
Read the detailed description
We studied consecutive patients diagnosed with PD according to the Queen Square Brain Bank Criteria [Hughes et al 1992] in a tertiary care center for movement disorders, from June 2018 to March 2020.
- Conditions
- Parkinson's Disease Aggravated
- Being tested
- sodium phosphate enema, oral rifaximin and polyethylene glycol
- Keywords
- Parkinson´s disease, Constipation, Dyskinesia, Microbiota
- Medical subject headings
- Parkinson Disease, Constipation, Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium phosphate enema, oral rifaximin and polyethylene glycolDrug
Patients were hospitalized for 4-5 hours to receive two saline colon enemas with sodium phosphate Fleet®, 2 to 3 hours apart, appropriate hydration was provided during the procedure. If signs of fecal impaction were observed, the stools were removed manually prior to the first enema. Patients were discharged with oral treatment consistent with rifaximin 200 mg three times a day for 7 days and polyethylene glycol-3350, 17 gr per day in water for 10 days, but it was continued if necessary. Importantly, no modifications in time and dose of dopaminergic therapy or anti-dyskinetic medication (i.e. amantadine) were done at baseline or during the study
| Study group | Role | What they receive |
|---|---|---|
| Microbiota modification | Experimental | Not described Receives: Drug: sodium phosphate enema, oral rifaximin and polyethylene glycol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in MDS-UPDRS-IV score
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start1 Jun 2018
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease AggravatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Torre Médica Santé
- Sponsor type
- Research network
- Responsible party
- Principal investigator, José Fidel Baizabal-Carvallo, Torre Médica Santé
- Investigators
- José Fidel Baizabal-Carvallo, M.D., Principal investigator, Torre Médica Sante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730245
- Sponsor's protocol ID
- 202004-001
- Status last verified
- Jan 2021
- First submitted
- 25 Jan 2021
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: May be shared by specific request
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Gut Microbiota for Motor Complications in Parkinson´s Disease
- ClinicalTrials.gov ID
- NCT04730245
- Acronym / sponsor ID
- 202004-001
- Conditions
- Parkinson's Disease Aggravated
- Keywords
- Parkinson´s disease, Constipation, Dyskinesia, Microbiota
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Torre Médica SantéResearch network
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In recent years, abnormalities in gut microbiota have been identified in patients with Parkinson´s disease having a possible role in motor manifestations. Among 80 patients with PD, we selected 14 with LID and motor fluctuations with limited response to pharmacological therapy to receive treatment with sodium phosphate enema, oral rifaximin and polyethylene glycol to improve motor complications.
Detailed description
We studied consecutive patients diagnosed with PD according to the Queen Square Brain Bank Criteria [Hughes et al 1992] in a tertiary care center for movement disorders, from June 2018 to March 2020.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microbiota modification | Experimental | Drug: sodium phosphate enema, oral rifaximin and polyethylene glycol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients aged 18-years old or older with moderate to severe dyskinesia and/or motor fluctuations with incomplete or poor response to adjustments in time and dose of levodopa and other anti-parkinsonian agents such as entacapone, rasagiline, dopamine receptor agonists and amantadine in 1-2 months prior to enrollment; defined by a Movement Disorders Society Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) part IV score equal or higher than 8 following pharmacological adjustments.
Key exclusion criteria (1 listed)
- patients with chronic renal failure, decompensated heart failure, colonic abnormalities precluding the use of evacuating enema, known allergies to prescribed medications to reduce microbiota load and patients who declined to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sodium phosphate enema, oral rifaximin and polyethylene glycolPatients were hospitalized for 4-5 hours to receive two saline colon enemas with sodium phosphate Fleet®, 2 to 3 hours apart, appropriate hydration was provided during the procedure. If signs of fecal impaction were observed, the stools were removed manually prior to the first enema. Patients were discharged with oral treatment consistent with rifaximin 200 mg three times a day for 7 days and polyethylene glycol-3350, 17 gr per day in water for 10 days, but it was continued if necessary. Importantly, no modifications in time and dose of dopaminergic therapy or anti-dyskinetic medication (i.e. amantadine) were done at baseline or during the study | Drug | Microbiota modification |
Primary outcome
Improvement in MDS-UPDRS-IV score
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Individual participant dataSharing planned: Undecided. May be shared by specific request
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Fidel Baizabal-Carvallo, M.D. principal investigator
Torre Médica Sante
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing sodium phosphate enema, oral rifaximin and polyethylene glycol in people with Parkinson's Disease Aggravated, run by Torre Médica Santé at 1 site in Mexico.
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 1 inclusion and 1 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 29 Jan 2021. 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 Mexico. 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?
Improvement in MDS-UPDRS-IV score (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2021.