Parkinson DiseaseGUT-PDNCT05787756
Constipation and Changes in the Gut Flora in Parkinson's Disease
An observational study of Parkinson Disease, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
The aim of this study is to investigate the link between gut health and Parkinson's disease Read more about this study
- Who is it for?
- Ages 18 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2023to 17 Mar 2024
- Phase
- Observational
- 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 to 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Parkinson disease group: potential participants will be invited into the study if they have recently been diagnosed with Parkinson's disease and have not yet started medication for the condition Control group: spouses or other household contacts will be invited to the study
Who may be able to join
- Participants with Parkinson's disease 2. Community-dwelling patients with newly diagnosed PD who have not yet started medication for Parkinson's disease.
- Control Participants
- 1. Healthy (non-Parkinsonian) members of the participants household will be invited to act as controls.
Who cannot join
- Use of oral or intravenous antibiotics in the last 8 weeks.
- Active gastrointestinal disease, not including constipation or irritable bowel syndrome without other symptoms.
- Current use of medications which cause/worsen constipation e.g., opioids, tramadol, gabapentin, pregabalin.
- Potential controls will be excluded if they report prodromal symptoms of PD, such as anosmia or rapid eye movement (REM) sleep disorder or display parkinsonian signs on examination.
- Inability to give informed consent at any stage of the study e.g., because of dementia.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Human Nutrition Unit, Rowett Institute, University of Aberdeen
Aberdeen, Aberdeen City, AB25 2ZD
About this study
Official title: Constipation and Changes in the Gut Flora in Parkinson's Disease: a Pilot Study
The aim of this study is to investigate the link between gut health and Parkinson's disease
Read the detailed description
Parkinson's disease (PD) is a common, age-related neurological condition, affecting approximately 145,000 people in the United Kingdom. Diagnostic symptoms include stiffness, tremor, unsteadiness and slow movements. Interestingly, while PD is usually considered to be a neurological condition, pathological changes occur in the gut years before diagnosis, often causing constipation. As such, the gut has attracted attention as a possible therapeutic target.
Previous studies have shown different profiles of gut bacteria and the short chain fatty acids (SCFAs) they produce in people with PD. There is evidence these changes might be significant to the disease course, as faecal transplants from people with PD worsened symptoms in a mouse model of PD. The mechanism for this is unclear, but changes in SCFAs and gut wall inflammation, have both been suggested. Studies so far have compared gut bacteria in people with and without PD, however, as the healthy controls often don't have constipation, it is unclear if the differences seen are due to PD itself or the associated constipation.
This pilot study aims to determine differences in the frequency of gut micro-organisms (bacteria, fungi and archaea) and gut function, other than those caused by constipation. 40 participants with a new diagnosis of PD will be recruited from Movement Disorder clinics within National Health Service (NHS) Grampian. 40 healthy (non-PD) controls will be recruited from the PD participants households (whenever feasible). All 80 participants will be clinically assessed and asked to provide two stool samples. The samples will be analysed for the frequency of gut micro-organisms, changes in gut function (short chain fatty acid concentrations) and gut inflammation (calprotectin concentrations).
The aim of this pilot study is to determine the key differences in gut micro-organisms in PD compared to controls, which may have a role in disease progression. It is likely that the results of this proof of concept study would need to be confirmed in a larger study before the investigators are able to plan an intervention trial, such as testing a prebiotic product, with the aim of normalising gut micro-organisms, and potentially modifying the disease course.
- Conditions
- Parkinson Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson disease | Participants with newly diagnosed Parkinson's disease | |
| Control Subjects | Control subjects - will be selected from household/spousal contacts of the participants with Parkinson's disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Micro-organism prevalence in stool sample
Stool samples will be posted to the Rowett Institute, and processed and analysed in the laboratory at The Rowett Institute, University of Aberdeen. The samples will be analysed for water content and microbial RNA/DNA will be extracted for genome analysis. When the analysis is complete, the faecal samples will be destroyed.
Measured: Baseline
Micro-organism prevalence in stool sample
Stool samples will be posted to the Rowett Institute, and processed and analysed in the laboratory at The Rowett Institute, University of Aberdeen. The samples will be analysed for water content and microbial RNA/DNA will be extracted for genome analysis. When the analysis is complete, the faecal samples will be destroyed.
Measured: Within two months of baseline
Secondary outcomes (12)
Analysis of stool samples for concentration of short chain fatty acids
Stool samples will be posted to the Rowett Institute via Royal Mail. Samples will be processed and analysed in the laboratory at The Rowett Institute, University of Aberdeen. The samples will be analysed for short chain fatty acid concentration (µmol/g).
Measured: Baseline
Analysis of stool samples for concentration of calprotectin
Stool samples will be posted to the Rowett Institute via Royal Mail. Samples will be processed and analysed in the laboratory at The Rowett Institute, University of Aberdeen. The samples will be analysed for short calprotectin concentration (µg/g).
Measured: Baseline
Analysis of stool samples for markers of gut function (short chain fatty acids and calprotectin)
Stool samples will be posted to the Rowett Institute via Royal Mail. Samples will be processed and analysed in the laboratory at The Rowett Institute, University of Aberdeen. The samples will be analysed for short chain fatty acid (SCFA) profile and calprotectin concentration. When the analysis is complete, the faecal samples will be destroyed.
Measured: Within two months of the baseline sample
To assess the extent of swallowing problems (dysphagia) by a questionnaire
Participants will be asked to completed a standardized swallowing questionnaire (Swallowing Disturbance Questionnaire), which has been validated in people with Parkinson's disease. The score ranges from 0-43, with a higher score increasing the likelihood for a swallowing problem, which would require further investigation
Measured: Baseline
To assess the extent of swallowing problems using a standardized swallowing test
Participants will be asked to drink 150 millilitres of cold water from a clear cup. The rater will sit at their side and record them on video for later analysis. The speed in ml/second and volume per average swallow will be recorded by determining if any residual volume is left, the number of seconds to complete the task and the number of swallows. The test will be terminated if there is any indication of aspiration of liquid.
Measured: Baseline
To assess the extent of swallowing problems using a standardized swallowing test
Participants will be asked to drink 150 millilitres of cold water from a clear cup. The rater will sit at their side and record them on video for later analysis. The speed in ml/second and volume per average swallow will be recorded by determining if any residual volume is left, the number of seconds to complete the task and the number of swallows. The test will be terminated if there is any indication of aspiration of liquid.
Measured: Four weeks after the baseline assessment
To assess taste sensation using a simple test
Participants taste recognition will be assessed using standardized taste strips from Burghart (sweet, salty, sour and bitter)
Measured: Baseline
To assess dietary intake over a 24 hour period using a structured interview
Following the initial visit, the participant will receive a phone call from a trained member of the team to perform a 24-hour dietary recall interview. This is a structured interview where participants are asked to recall all food and beverage consumption over a 24-hour period and further questions are asked to determine further details, including portion size and ingredients and cooking methods used. The whole interview usually takes 20 to 60 minutes.
Measured: Baseline
To assess the reliability of bio-impedence analysis in determining fat mass in older adults with and without PD
Fat mass in kilograms will be measured using a seca mBCA 525 bio-impedence machine.
Measured: Baseline
To assess the reliability of bio-impedence analysis in determining fat mass in older adults
Fat mass in kilograms will be measured using a seca mBCA 525 bio-impedence machine.
Measured: Four weeks after baseline assessment
To assess the reliability of bio-impedence analysis in determining fat mass in older adults
Fat free mass in kilograms will be measured using a seca mBCA 525 bio-impedence machine.
Measured: Baseline
To assess the reliability of bio-impedence analysis in determining fat mass in older adults
Fat free mass in kilograms will be measured using a seca mBCA 525 bio-impedence machine.
Measured: Four weeks after the baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start1 Jan 2023
- Primary completion17 Mar 2024
- Study completion17 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- Biomathematics & Statistics Scotland (BioSS), NHS Grampian
- Responsible party
- Sponsor
- Investigators
- Isobel JM Sleeman, BMBCh, PhD, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787756
- Sponsor's protocol ID
- 2-048-21
- Acronym
- GUT-PD
- Status last verified
- Aug 2026
- First submitted
- 1 Mar 2023
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gage H, Kaye J, Kimber A, Storey L, Egan M, Qiao Y, Trend P. Correlates of constipation in people with Parkinson's. Parkinsonism Relat Disord. 2011 Feb;17(2):106-11. doi: 10.1016/j.parkreldis.2010.11.003. Epub 2010 Dec 3.
PubMed 21130017De Pablo-Fernandez E, Gebeyehu GG, Flain L, Slater R, Frau A, Ijaz UZ, Warner T, Probert C. The faecal metabolome and mycobiome in Parkinson's disease. Parkinsonism Relat Disord. 2022 Feb;95:65-69. doi: 10.1016/j.parkreldis.2022.01.005. Epub 2022 Jan 13.
PubMed 35045378Hilton D, Stephens M, Kirk L, Edwards P, Potter R, Zajicek J, Broughton E, Hagan H, Carroll C. Accumulation of alpha-synuclein in the bowel of patients in the pre-clinical phase of Parkinson's disease. Acta Neuropathol. 2014 Feb;127(2):235-41. doi: 10.1007/s00401-013-1214-6. Epub 2013 Nov 17.
PubMed 24240814Jaffrin MY, Morel H. Body fluid volumes measurements by impedance: A review of bioimpedance spectroscopy (BIS) and bioimpedance analysis (BIA) methods. Med Eng Phys. 2008 Dec;30(10):1257-69. doi: 10.1016/j.medengphy.2008.06.009. Epub 2008 Aug 3.
PubMed 18676172Manor Y, Giladi N, Cohen A, Fliss DM, Cohen JT. Validation of a swallowing disturbance questionnaire for detecting dysphagia in patients with Parkinson's disease. Mov Disord. 2007 Oct 15;22(13):1917-21. doi: 10.1002/mds.21625.
PubMed 17588237Mueller C, Kallert S, Renner B, Stiassny K, Temmel AF, Hummel T, Kobal G. Quantitative assessment of gustatory function in a clinical context using impregnated "taste strips". Rhinology. 2003 Mar;41(1):2-6.
PubMed 12677732Sampson TR, Debelius JW, Thron T, Janssen S, Shastri GG, Ilhan ZE, Challis C, Schretter CE, Rocha S, Gradinaru V, Chesselet MF, Keshavarzian A, Shannon KM, Krajmalnik-Brown R, Wittung-Stafshede P, Knight R, Mazmanian SK. Gut Microbiota Regulate Motor Deficits and Neuroinflammation in a Model of Parkinson's Disease. Cell. 2016 Dec 1;167(6):1469-1480.e12. doi: 10.1016/j.cell.2016.11.018.
PubMed 27912057Schwiertz A, Spiegel J, Dillmann U, Grundmann D, Burmann J, Fassbender K, Schafer KH, Unger MM. Fecal markers of intestinal inflammation and intestinal permeability are elevated in Parkinson's disease. Parkinsonism Relat Disord. 2018 May;50:104-107. doi: 10.1016/j.parkreldis.2018.02.022. Epub 2018 Feb 12.
PubMed 29454662Unger MM, Spiegel J, Dillmann KU, Grundmann D, Philippeit H, Burmann J, Fassbender K, Schwiertz A, Schafer KH. Short chain fatty acids and gut microbiota differ between patients with Parkinson's disease and age-matched controls. Parkinsonism Relat Disord. 2016 Nov;32:66-72. doi: 10.1016/j.parkreldis.2016.08.019. Epub 2016 Aug 26.
PubMed 27591074
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constipation and Changes in the Gut Flora in Parkinson's Disease: a Pilot Study
- ClinicalTrials.gov ID
- NCT05787756
- Acronym / sponsor ID
- GUT-PD / 2-048-21
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- Biomathematics & Statistics Scotland (BioSS), NHS Grampian
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 17 Mar 2024 (actual)
- Study completion
- 17 Mar 2024 (actual)
- First posted
- 28 Mar 2023 (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.
The aim of this study is to investigate the link between gut health and Parkinson's disease
Detailed description
Parkinson's disease (PD) is a common, age-related neurological condition, affecting approximately 145,000 people in the United Kingdom. Diagnostic symptoms include stiffness, tremor, unsteadiness and slow movements. Interestingly, while PD is usually considered to be a neurological condition, pathological changes occur in the gut years before diagnosis, often causing constipation. As such, the gut has attracted attention as a possible therapeutic target.
Previous studies have shown different profiles of gut bacteria and the short chain fatty acids (SCFAs) they produce in people with PD. There is evidence these changes might be significant to the disease course, as faecal transplants from people with PD worsened symptoms in a mouse model of PD. The mechanism for this is unclear, but changes in SCFAs and gut wall inflammation, have both been suggested. Studies so far have compared gut bacteria in people with and without PD, however, as the healthy controls often don't have constipation, it is unclear if the differences seen are due to PD itself or the associated constipation.
This pilot study aims to determine differences in the frequency of gut micro-organisms (bacteria, fungi and archaea) and gut function, other than those caused by constipation. 40 participants with a new diagnosis of PD will be recruited from Movement Disorder clinics within National Health Service (NHS) Grampian. 40 healthy (non-PD) controls will be recruited from the PD participants households (whenever feasible). All 80 participants will be clinically assessed and asked to provide two stool samples. The samples will be analysed for the frequency of gut micro-organisms, changes in gut function (short chain fatty acid concentrations) and gut inflammation (calprotectin concentrations).
The aim of this pilot study is to determine the key differences in gut micro-organisms in PD compared to controls, which may have a role in disease progression. It is likely that the results of this proof of concept study would need to be confirmed in a larger study before the investigators are able to plan an intervention trial, such as testing a prebiotic product, with the aim of normalising gut micro-organisms, and potentially modifying the disease course.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson disease | – | –Participants with newly diagnosed Parkinson's disease |
| Control Subjects | – | –Control subjects - will be selected from household/spousal contacts of the participants with Parkinson's disease |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson disease group: potential participants will be invited into the study if they have recently been diagnosed with Parkinson's disease and have not yet started medication for the condition Control group: spouses or other household contacts will be invited to the study
Key inclusion criteria (3 listed)
- Participants with Parkinson's disease 2. Community-dwelling patients with newly diagnosed PD who have not yet started medication for Parkinson's disease.
- Control Participants
- 1. Healthy (non-Parkinsonian) members of the participants household will be invited to act as controls.
Key exclusion criteria (5 listed)
- Use of oral or intravenous antibiotics in the last 8 weeks.
- Active gastrointestinal disease, not including constipation or irritable bowel syndrome without other symptoms.
- Current use of medications which cause/worsen constipation e.g., opioids, tramadol, gabapentin, pregabalin.
- Potential controls will be excluded if they report prodromal symptoms of PD, such as anosmia or rapid eye movement (REM) sleep disorder or display parkinsonian signs on examination.
- Inability to give informed consent at any stage of the study e.g., because of dementia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Micro-organism prevalence in stool sample
Time frame: Baseline
Stool samples will be posted to the Rowett Institute, and processed and analysed in the laboratory at The Rowett Institute, University of Aberdeen. The samples will be analysed for water content and microbial RNA/DNA will be extracted for genome analysis. When the analysis is complete, the faecal samples will be destroyed.
Micro-organism prevalence in stool sample
Time frame: Within two months of baseline
Stool samples will be posted to the Rowett Institute, and processed and analysed in the laboratory at The Rowett Institute, University of Aberdeen. The samples will be analysed for water content and microbial RNA/DNA will be extracted for genome analysis. When the analysis is complete, the faecal samples will be destroyed.
12 secondary outcomes
Analysis of stool samples for concentration of short chain fatty acids
Time frame: Baseline
Analysis of stool samples for concentration of calprotectin
Time frame: Baseline
Analysis of stool samples for markers of gut function (short chain fatty acids and calprotectin)
Time frame: Within two months of the baseline sample
To assess the extent of swallowing problems (dysphagia) by a questionnaire
Time frame: Baseline
To assess the extent of swallowing problems using a standardized swallowing test
Time frame: Baseline
To assess the extent of swallowing problems using a standardized swallowing test
Time frame: Four weeks after the baseline assessment
To assess taste sensation using a simple test
Time frame: Baseline
To assess dietary intake over a 24 hour period using a structured interview
Time frame: Baseline
To assess the reliability of bio-impedence analysis in determining fat mass in older adults with and without PD
Time frame: Baseline
To assess the reliability of bio-impedence analysis in determining fat mass in older adults
Time frame: Four weeks after baseline assessment
To assess the reliability of bio-impedence analysis in determining fat mass in older adults
Time frame: Baseline
To assess the reliability of bio-impedence analysis in determining fat mass in older adults
Time frame: Four weeks after the baseline assessment
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 31 Aug 2026.
- Background: PubMed 21130017Gage H, Kaye J, Kimber A, Storey L, Egan M, Qiao Y, Trend P. Correlates of constipation in people with Parkinson's. Parkinsonism Relat Disord. 2011 Feb;17(2):106-11. doi: 10.1016/j.parkreldis.2010.11.003. Epub 2010 Dec 3.
- Background: PubMed 35045378De Pablo-Fernandez E, Gebeyehu GG, Flain L, Slater R, Frau A, Ijaz UZ, Warner T, Probert C. The faecal metabolome and mycobiome in Parkinson's disease. Parkinsonism Relat Disord. 2022 Feb;95:65-69. doi: 10.1016/j.parkreldis.2022.01.005. Epub 2022 Jan 13.
- Background: PubMed 24240814Hilton D, Stephens M, Kirk L, Edwards P, Potter R, Zajicek J, Broughton E, Hagan H, Carroll C. Accumulation of alpha-synuclein in the bowel of patients in the pre-clinical phase of Parkinson's disease. Acta Neuropathol. 2014 Feb;127(2):235-41. doi: 10.1007/s00401-013-1214-6. Epub 2013 Nov 17.
- Background: PubMed 18676172Jaffrin MY, Morel H. Body fluid volumes measurements by impedance: A review of bioimpedance spectroscopy (BIS) and bioimpedance analysis (BIA) methods. Med Eng Phys. 2008 Dec;30(10):1257-69. doi: 10.1016/j.medengphy.2008.06.009. Epub 2008 Aug 3.
- Background: PubMed 17588237Manor Y, Giladi N, Cohen A, Fliss DM, Cohen JT. Validation of a swallowing disturbance questionnaire for detecting dysphagia in patients with Parkinson's disease. Mov Disord. 2007 Oct 15;22(13):1917-21. doi: 10.1002/mds.21625.
- Background: PubMed 12677732Mueller C, Kallert S, Renner B, Stiassny K, Temmel AF, Hummel T, Kobal G. Quantitative assessment of gustatory function in a clinical context using impregnated "taste strips". Rhinology. 2003 Mar;41(1):2-6.
- Background: PubMed 27912057Sampson TR, Debelius JW, Thron T, Janssen S, Shastri GG, Ilhan ZE, Challis C, Schretter CE, Rocha S, Gradinaru V, Chesselet MF, Keshavarzian A, Shannon KM, Krajmalnik-Brown R, Wittung-Stafshede P, Knight R, Mazmanian SK. Gut Microbiota Regulate Motor Deficits and Neuroinflammation in a Model of Parkinson's Disease. Cell. 2016 Dec 1;167(6):1469-1480.e12. doi: 10.1016/j.cell.2016.11.018.
- Background: PubMed 29454662Schwiertz A, Spiegel J, Dillmann U, Grundmann D, Burmann J, Fassbender K, Schafer KH, Unger MM. Fecal markers of intestinal inflammation and intestinal permeability are elevated in Parkinson's disease. Parkinsonism Relat Disord. 2018 May;50:104-107. doi: 10.1016/j.parkreldis.2018.02.022. Epub 2018 Feb 12.
- Background: PubMed 27591074Unger MM, Spiegel J, Dillmann KU, Grundmann D, Philippeit H, Burmann J, Fassbender K, Schwiertz A, Schafer KH. Short chain fatty acids and gut microbiota differ between patients with Parkinson's disease and age-matched controls. Parkinsonism Relat Disord. 2016 Nov;32:66-72. doi: 10.1016/j.parkreldis.2016.08.019. Epub 2016 Aug 26.
- Individual participant dataSharing planned: No
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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.
Isobel JM Sleeman, BMBCh, PhD principal investigator
University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by University of Aberdeen at 1 site in United Kingdom.
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 3 inclusion and 5 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 31 Aug 2026. 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 Kingdom. 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.
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?
Micro-organism prevalence in stool sample (time frame: Baseline). The study lists 2 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 NCT05787756, which also lists 9 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 31 Aug 2026.