AzTrials
AzTrials

Patient ParticipationPre-Pro-MSNCT05779449

Targeting the Gut Dysbiosis to Treat Inflammation-driven Synaptopathy in MS

A study testing Prebiotics and Probiotics supplementation, peripheral blood withdrawal and Transcranial Magnetic Stimulation (TMS) in people with Patient Participation, run by Neuromed IRCCS at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Inflammatory synaptopathy is a prominent pathogenic process in multiple sclerosis (MS) induced by imbalanced immune system homeostasis. Its persistence causes excitotoxic neuronal damage, leading to motor and cognitive deficits. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Patient Participation
What is being tested?
Prebiotics and Probiotics supplementation, peripheral blood withdrawal and Transcranial Magnetic Stimulation (TMS)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteItaly
Study dates
26 Jul 2023to 1 May 2026
Phase
Interventional
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • RRMS diagnosis, as Polman et al 2011. Ann Neurol. PMID: 21387374
  • Age <= 18 and => 65 years
  • EDSS score <= 7
  • Disease duration < 10 years
  • On DMF or Ocrelizumab treatment from at least 3 months
  • No corticosteroid administration in the previous month
  • Ability to provide written informed consent.

Who cannot join

  • Adverse effects to gadolinium
  • Blood count basal alteration
  • Pregnant or lactating women
  • Vegetarians or vegans
  • Taking antibiotics, any product or supplement containing probiotics, Omega 3 or other antioxidant supplements within 30 days prior to inclusion
  • History of food allergies or food intolerance
  • Clinically significant medical condition other than MS, (latent infections, other autoimmune disease)
  • Diagnosis of past eating disorders (anorexia, bulimia, or binge eating) or relevant psychiatric disorders.

Trial locations and contacts

1 site in 1 country.

Silvia Caioli, MD contact

+39 3332790061

silviacaioli@yahoo.it

Diego Centonze, MD contact

+39 3934444159

centonze@uniroma2.it

Italy1 site, 1 recruiting

  • IRCCS INM-Neuromed

    Pozzilli, Isernia, 86077

    Stefania Passarelli, +39 0865915217, direzionescientifica@neuromed.it

    Recruiting

Other trials in Italy

About this study

Official title: Targeting the Gut Dysbiosis to Treat Inflammation-driven Synaptopathy in Multiple Sclerosis

Inflammatory synaptopathy is a prominent pathogenic process in multiple sclerosis (MS) induced by imbalanced immune system homeostasis. Its persistence causes excitotoxic neuronal damage, leading to motor and cognitive deficits. Although many advances have been made in MS treatment, the development of effective strategies for managing disease progression driven by excitotoxic synaptic dysfunctions is of great significance. Gut dysbiosis is commonly associated with both MS and obesity and high-fat diet (HFD) can exacerbate disease by acting on gut microbiota.

Since gut microbiota can shape the immune response and brain functions, we propose to target gut dysbiosis by dietary supplementation of prebiotics and probiotics (Pre-Pro) to treat synaptopathy in both human and experimental model of MS, even when exacerbated by HFD. Overall, this project aims at unveiling the anti-inflammatory and neuroprotective pathways activated by Pre-Pro supplementation to modulate the immune-synaptic axis.

Read the detailed description

MS is a chronic autoimmune neurodegenerative disease characterized by different forms. The most common is the relapsing-remitting (RR)MS showing a significant dysregulation of immune homeostasis.

Disease progression occurring during MS, is not only driven by infiltrating T cells destroying myelin during relapses, indeed proinflammatory molecules can also trigger a glutamate-induced excitotoxic synaptopathy promoting neurodegenerative processes and negatively influencing disease course.

Inflammation, synaptopathy and neurodegeneration are intermingled with reparative processes in different proportions, making the MS course unpredictable and the treatment approach challenging. Lifestyle habits can contribute to the heterogeneity of MS pathophysiology. In this context, the gut microbiota is emerging as a key sensor of lifestyle indeed it is continuously modulated by many factors, particularly dietary habits, and by controlling the immune system homeostasis can influence the onset and progression of MS.

HFD exacerbates MS by promoting neuroinflammation and affects gut microbiota inducing dysbiosis.

Gut dysbiosis in MS is associated with increased microglia activation and imbalance between pathogenic Th1/Th17 and tolerogenic regulatory T (Treg cells), however its effects on immune-mediated synaptopathy and their underlying mechanisms in MS have not yet been investigated.

Considering that excitotoxic synaptic dysfunctions are reversible and can be only partially controlled by the currently available disease-modifying treatments (DMTs), they represent an attractive therapeutic target in MS. Microbiota manipulation by dietary prebiotics and probiotics (Pre-Pro) supplementation may be an attractive candidate for enhancing the efficacy and the anti-synaptotoxic action of DMTs and could result in a safer and more effective therapeutic strategy to improve the management of overall health and well-being of MS patients.

This clinical study will be performed to verify whether the gut-microbiota manipulation can counteract synaptic alterations, neuroinflammation and degeneration by switching the immune system towards a more tolerogenic phenotype thus improving MS cognitive and clinical outcomes.

To verify our hypothesis, we will perform clinical and experimental studies to dissect at cellular and molecular level the effect and the mechanism of action of Pre-Pro supplementation during MS.

The following objectives will be addressed by evaluating the effects of a dietary supplementation of prebiotics and probiotics (Pre-Pro) in RRMS patients on

  1. clinical disability and disease course;
  2. immune cell homeostasis;
  3. inflammation-driven synaptopathy and its molecular determinants.

This project aims at investigating for the first time the impact of gut-microbiota modulation on MS course associated with excitotoxic synaptopathy. The multidisciplinary approach will provide the unique opportunity to dissect immunoregulatory and synaptic effects of the prolonged Pre-Pro intake at both cellular and molecular levels. Moreover, the possible identification of novel molecular actors controlling the immune-brain axis shaped by the microbiota will open new opportunities for expanding the current treatment options for MS.

Overall, the results of this project will provide robust scientific groundwork for an integrative medicine based on Pre-Pro supplementation in addition to first line drug treatments for MS to counteract synaptopathy-driven disease progression.

Being tested
Prebiotics and Probiotics supplementation, Placebo supplementation, peripheral blood withdrawal, Transcranial Magnetic Stimulation (TMS)
Keywords
gut microbiota, dysbiosis, multiple sclerosis, glutamate-mediated excitotoxicity, synaptopathy
Medical subject headings
Patient Participation, Dysbiosis, Multiple Sclerosis

What participants receive

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

  • Prebiotics and Probiotics supplementationDietary supplement

    From the 1st day to the 15th day (included) patients with MS in the Pre-Pro group will receive daily:

    1 capsule of Probactiol Duo, Metagenics (6 billions of Saccharomyces boulardii and 8,5 billions of probiotics including Bifidobacterium lactis Bi-07®, Bifidobacterium lactis Bl-04, Lacticaseibacillus paracasei Lpc-37, Lactobacillus acidophilus NCFM®)

    1. packet of Probactiol Stips, Metagenics (4 g inulin enriched with oligofructose) From the16th day to the 365th day (included) patients with MS in the Pre-Pro group will receive daily:
    2. capsules of Probactiol HMO Combi, Metagenics (7,5 billions of Lactobacillus acidophilus NCFM®, 7,5 billions of Bifidobacterium lactis Bi-07®, 2,5 ug Vitamine D3, 320 ug Vitamine A, 100 mg Threonine, 250 mg 2'-Fucosyllactose).

  • Placebo supplementationDietary supplement

    1-year supplementation with two placebo capsules/day containing starch, the probiotic bacteria carrier.

  • peripheral blood withdrawalProcedure or surgery

    40 ml of blood for the isolation of Peripheral Blood Cells (PBMCs) and T cells.

  • Transcranial Magnetic Stimulation (TMS)Procedure or surgery

    Intermittent theta burst stimulation (iTBS) protocol

Study groups in NCT05779449
Study groupRoleWhat they receive
Pre-Pro groupExperimentalPatients with RRMS under dimethyl fumarate or Ocrelizumab treatment according to the good clinical practice, who will recieve the following dietary supplementation with pre- and probiotics: 1st-15th days: One capsule containg 6 billions of Saccharomyces boulardii and 8,5 billions of probiotics including Bifidobacterium lactis Bi-07®, Bifidobacterium lactis Bl-04, Lacticaseibacillus paracasei Lpc-37, Lactobacillus acidophilus NCFM® (Probactiol Duo cps, Metagenics) One packet with 4 g of prebiotics including inulin enriched with oligofructose (Probactiol Stips bustine Metagenics). 16th-365th days: Two capsules, each containg 7,5 billions of Lactobacillus acidophilus NCFM®, 7,5 billions of Bifidobacterium lactis Bi-07®, 2,5 ug Vitamine D3, 320 ug Vitamine A, 100 mg Threonine, 250 mg 2'-Fucosyllactose (Probactiol HMO Combi cps, Metagenics).
Receives: Dietary Supplement: Prebiotics and Probiotics supplementation; Procedure: peripheral blood withdrawal; Procedure: Transcranial Magnetic Stimulation (TMS)
Placebo groupPlacebo comparatorPatients with RRMS under dimethyl fumarate or Ocrelizumab treatment according to the good clinical practice, who will receive only starch, the probiotic bacteria carrier: 1st-15th days: One capsule and one packet only with starch. 16th-365th days: Two capsules containg starch.
Receives: Dietary Supplement: Placebo supplementation; Procedure: peripheral blood withdrawal; Procedure: Transcranial Magnetic Stimulation (TMS)

What is being measured

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

  1. Changes in gut microbiota diversity or composition

    Relative taxa abundance in fecal samples assessed by rDNA-seq (Operational Taxonomy Unit, OTU).

    Measured: T0 vs T12 (months), Pre-Pro versus Placebo groups

  2. Changes in microbiota metabolites - indican

    Quantification of the ration between indican and creatinine (μg/mg) in urine samples

    Measured: T0 vs T12 (months), Pre-Pro versus Placebo groups

  3. Changes in microbiota metabolites - skatole

    Quantification of the ration between skatole and creatinine (μg/mg) in urine samples

    Measured: T0 vs T12 (months), Pre-Pro versus Placebo groups

  4. Changes in serum glutamate

    Absolute quantification of glutamate in the serum (uM)

    Measured: T0 vs T12 (months), Pre-Pro versus Placebo groups

  5. Changes in serum synaptotoxic miRNAs

    Relative quantification by Real-time PCR

    Measured: T0 vs T12 (months), Pre-Pro versus Placebo groups

  6. Changes in plasma inflammatory molecules

    Absolute quantification of inflammatory molecules in the serum (pg/ml)

    Measured: T0 vs T12 (months), Pre-Pro versus Placebo groups

  7. Changes in immunophenotype

    The percentage of Treg in the activated CD4+CD25- T cells isolated from PMBCs will be evaluated by Fluorescence-activated Cell Sorting (FACS).

    Measured: T0 vs T12 (months), Pre-Pro versus Placebo groups

  8. Changes in T cell metabolic asset

    The metabolic profile of CD4+ T cells will be assessed by real-time measurement of extracellular acidification rate (ECAR) and oxygen consumption rate (OCR), using an XFe-96 Extracellular Flux Analyzer.

    Measured: T0 vs T12 (months), Pre-Pro versus Placebo groups

Secondary outcomes (17)

  1. Changes in neurophysiological response

    A protocol of Intermittent theta burst stimulation (iTBS) will be used to evaluate change in Motor-Evoked Potentials (MEP) before (baseline) and after 15 and 30 minutes from stimuli (10 bursts, each burst composed of three stimuli at 50 Hz).

    Twenty MEPs will be collected at each time points.MEP's amplitudes will be averaged at each time point and normalized to the mean baseline amplitude.

    Measured: T0 vs T12 (months), Pre-Pro versus Placebo groups

  2. Changes in clinical disability

    The Expanded Disability Status Scale (EDSS)/Kurtzke is widely used in MS clinical pactice and trials to quantify disability and monitor the changes in the level of disability over time. The EDSS scale ranges from 0 to 10.

    Measured: T0 vs T12 (months), Pre-Pro versus Placebo groups

  3. Changes in lower extremity function

    Quantitative measure of lower extremity function will be performed by the Timed 25-Foot Walk (T25FW). The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. The average score of two 25-Foot Timed Walk trials will be measured.

    Measured: T0 vs T12 (months), Pre-Pro versus Placebo groups

  4. Changes in upper extremity function

    The upper extremity (arm and hand) function will be assessed by 9-Hole Peg Test (9HPT). Both the dominant and non-dominant hands are tested twice. Two consecutive trials of the dominant hand, followed immediately by two consecutive trials of the non-dominant hand will be executed.

    Measured: T0 vs T12 (months), Pre-Pro versus Placebo groups

  5. Changes in quality of life

    The Multiple Sclerosis Quality of Life-54 (MSQOL-54) is a multidimensional health-related quality of life measure that combines both generic and MS-specific items into a single instrument.

    The test includes 36 items as the generic component and 18 items added to tap MS-specific issues such as fatigue, cognitive function, etc. This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The summary scores are the physical health composite summary and the mental health composite summary. The single item measures are satisfaction with sexual function and change in health.

    Administration time of this structured, self-report questionnaire is approximately 11-18 minutes.

    Measured: T0 vs T12 (months), Pre-Pro versus Placebo groups

  6. Assessment of mild to moderate dysfunctions

    The Paced Auditory Serial Addition Test (PASAT) will be used to measure the cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. The score for the PASAT is the total number correct out of 60 possible answers. This score can be used individually or used as part of the MSFC composite score. Administration time is approximately 10-15 minutes including practice sessions.

    Measured: T0 vs T12 (months), Pre-Pro versus Placebo groups

  7. Changes in global cognitive disability

    Mini Mental State Examination (MMSE) will be used to assess cognitive function including orientation, attention, memory, language and visual-spatial skills.

    Measured: T0 vs T12 (months), Pre-Pro versus Placebo groups

  8. Assessment of attention and information processing speed

    Attention and information processing speed will be evaluated by the Symbol Digit Modality Test (SDMT).

    The examinee has 90 seconds to pair specific numbers with given geometric figures by using a reference key. The SDMT score is the sum of the correct substitutions within the 90 second interval.

    Measured: T0 vs T12 (months), Pre-Pro versus Placebo groups

  9. Changes in phonemic verbal fluency

    Word List Generation (WLG) will be used as a phonemic verbal fluency task to evaluate the spontaneous production of words and mental flexibility, when given a letter from the alphabet and within a limited amount of time (one minute).

    Measured: T0 vs T12 (months), Pre-Pro versus Placebo groups

  10. Changes in verbal memory performance

    Rey Auditory Verbal Learning Test (RAVLT) will be used to evaluate verbal memory.

    Measured: T0 vs T12 (months), Pre-Pro versus Placebo groups

  11. Changes in measure visuospatial memory

    The Brief Visuospatial Memory Test-Revised (BVMT-R) will be used to measure visuospatial memory.

    Measured: T0 vs T12 (months), Pre-Pro versus Placebo groups

  12. Changes in depressive symptoms

    Beck Depression Inventory-Second Edition (BDI-II) will be used to assess the presence of depressive symptoms. This scale includes 21 items and investigates both somatic and cognitive-affective symptoms, the score range is from 0 to 63. A cutoff of 13 will be used to detect depression.

    Measured: T0 vs T12 (months), Pre-Pro versus Placebo groups

  13. Changes in anxious symptoms

    State-Trait Anxiety Inventory form Y (STAI-Y) will be used to asses levels of anxiety. It consists of a 40-item self-administered questionnaire exploring both the levels of situational anxiety (state) and the tendency to anxious situations (trait). A cutoff for high anxiety will be derived according to normative data.

    Measured: T0 vs T12 (months), Pre-Pro versus Placebo groups

  14. Changes in disease progression index (PI)

    Progression index (PI) is the ratio between EDSS (Expanded Disability Status Scale) and disease duration in months.

    Measured: T0 vs T12 (months), Pre-Pro versus Placebo groups

  15. Changes in the Annualized Relapse Rate (ARR)

    Change in Annualized Relapse Rate (ARR) measured by the total number of relapses divided by the total person-time at risk of relapse.

    Measured: T0 vs T12 (months), Pre-Pro versus Placebo groups

  16. Changes in radiological activity

    Radiological activity will be evaluated by conventional MRI scans (1.5 Tesla) after intravenous gadolinium (Gd) infusion (0.2 ml/kg). An active scan is defined as showing any new, enlarging or recurrent lesion(s) on T1-weighted spin-echo images (T1-WI) and T2-weighted spin-echo images (T2-WI).

    A new Gd+ lesion is defined as a typical area of hyperintense signal on postcontrast T1-WI.

    A new or newly enlarging lesion on T2-WI is defined as a rounded or oval lesion arising from an area previously considered as normal appearing brain tissue and/or showing an identifiable increase in size from a previously stable-appearing lesion.

    Measured: T0 vs T12 (months), Pre-Pro versus Placebo groups

  17. Changes in brain atrophy

    Difference of cortical thickness, the volume of subcortical grey matter structures and lesion volume will be evaluated by MRI scan

    Measured: T0 vs T12 (months), Pre-Pro versus Placebo groups

Timeline

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

  1. First posted22 Mar 2023
  2. Study start26 Jul 2023
  3. Primary completion2 Nov 2024 (estimated)
  4. Study completion1 May 2026 (estimated)

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05779449
Sponsor's protocol ID
Pre-Pro-MS
Acronym
Pre-Pro-MS
Status last verified
Aug 2023
First submitted
6 Mar 2023
Last updated
14 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mandolesi G, Gentile A, Musella A, Fresegna D, De Vito F, Bullitta S, Sepman H, Marfia GA, Centonze D. Synaptopathy connects inflammation and neurodegeneration in multiple sclerosis. Nat Rev Neurol. 2015 Dec;11(12):711-24. doi: 10.1038/nrneurol.2015.222. Epub 2015 Nov 20.

    PubMed 26585978

  • De Vito F, Musella A, Fresegna D, Rizzo FR, Gentile A, Stampanoni Bassi M, Gilio L, Buttari F, Procaccini C, Colamatteo A, Bullitta S, Guadalupi L, Caioli S, Vanni V, Balletta S, Sanna K, Bruno A, Dolcetti E, Furlan R, Finardi A, Licursi V, Drulovic J, Pekmezovic T, Fusco C, Bruzzaniti S, Hornstein E, Uccelli A, Salvetti M, Matarese G, Centonze D, Mandolesi G. MiR-142-3p regulates synaptopathy-driven disease progression in multiple sclerosis. Neuropathol Appl Neurobiol. 2022 Feb;48(2):e12765. doi: 10.1111/nan.12765. Epub 2021 Oct 6.

    PubMed 34490928

  • Stampanoni Bassi M, Iezzi E, Buttari F, Gilio L, Simonelli I, Carbone F, Micillo T, De Rosa V, Sica F, Furlan R, Finardi A, Fantozzi R, Storto M, Bellantonio P, Pirollo P, Di Lemme S, Musella A, Mandolesi G, Centonze D, Matarese G. Obesity worsens central inflammation and disability in multiple sclerosis. Mult Scler. 2020 Sep;26(10):1237-1246. doi: 10.1177/1352458519853473. Epub 2019 Jun 4.

    PubMed 31161863

  • Buckman LB, Hasty AH, Flaherty DK, Buckman CT, Thompson MM, Matlock BK, Weller K, Ellacott KL. Obesity induced by a high-fat diet is associated with increased immune cell entry into the central nervous system. Brain Behav Immun. 2014 Jan;35:33-42. doi: 10.1016/j.bbi.2013.06.007. Epub 2013 Jul 4.

    PubMed 23831150

  • Haase S, Wilck N, Haghikia A, Gold R, Mueller DN, Linker RA. The role of the gut microbiota and microbial metabolites in neuroinflammation. Eur J Immunol. 2020 Dec;50(12):1863-1870. doi: 10.1002/eji.201847807. Epub 2020 Dec 7.

    PubMed 33188704

  • Mirashrafi S, Hejazi Taghanaki SZ, Sarlak F, Moravejolahkami AR, Hojjati Kermani MA, Haratian M. Effect of probiotics supplementation on disease progression, depression, general health, and anthropometric measurements in relapsing-remitting multiple sclerosis patients: A systematic review and meta-analysis of clinical trials. Int J Clin Pract. 2021 Nov;75(11):e14724. doi: 10.1111/ijcp.14724. Epub 2021 Aug 19.

    PubMed 34379879

  • Siracusa F, Schaltenberg N, Villablanca EJ, Huber S, Gagliani N. Dietary Habits and Intestinal Immunity: From Food Intake to CD4+ T H Cells. Front Immunol. 2019 Jan 15;9:3177. doi: 10.3389/fimmu.2018.03177. eCollection 2018.

    PubMed 30697217

  • Valizadeh S, Majdi Seghinsara A, Maleki Chollou K, Bahadori A, Abbaszadeh S, Taghdir M, Behniafar H, Riahi SM. The efficacy of probiotics in experimental autoimmune encephalomyelitis (an animal model for MS): a systematic review and meta-analysis. Lett Appl Microbiol. 2021 Oct;73(4):408-417. doi: 10.1111/lam.13543. Epub 2021 Aug 11.

    PubMed 34310737

  • Sichetti M, De Marco S, Pagiotti R, Traina G, Pietrella D. Anti-inflammatory effect of multistrain probiotic formulation (L. rhamnosus, B. lactis, and B. longum). Nutrition. 2018 Sep;53:95-102. doi: 10.1016/j.nut.2018.02.005. Epub 2018 Feb 14.

    PubMed 29674267

Questions about this trial

What is this clinical trial studying?

A study testing Prebiotics and Probiotics supplementation, peripheral blood withdrawal and Transcranial Magnetic Stimulation (TMS) in people with Patient Participation, run by Neuromed IRCCS at 1 site in Italy.

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: status not confirmed, as of the sponsor's last update on 14 Aug 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 Italy. 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. 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.

Are results available for this study?

Results are not available in the source record.

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

Contact Silvia Caioli, MD (+39 3332790061, silviacaioli@yahoo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in gut microbiota diversity or composition (time frame: T0 vs T12 (months), Pre-Pro versus Placebo groups). The study lists 8 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 NCT05779449, 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 14 Aug 2023.

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