ExerciseCKDNCT07483697
Multimodal Intervention for Early Chronic Kidney Disease in Young People: Dysbiosis and Inflammation (CKD)
A study testing symbiotic in people with Exercise and Diet Interventions, run by Centenario Hospital Miguel Hidalgo at 1 site in Mexico.
Trial summary
Chronic kidney disease (CKD) is a progressive condition associated with substantial morbidity, mortality, and healthcare costs. Early detection and timely intervention are critical to modify disease trajectory, particularly in adolescents and young adults. Read more about this study
- Who is it for?
- Ages 14 to 35 years
- Conditions the study is for
- Exercise, Diet Interventions, Symbiotic
- What is being tested?
- symbiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteMexico
- Study dates
- 25 Apr 2026to 3 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Persistent albuminuria (ACR >30 and <300 mg/g).
- Estimated GFR >60 mL/min/1.73 m².
- No identifiable secondary cause of kidney disease.
Who cannot join
- Hypoalbuminemia.
- Nephrotic syndrome.
- Persistent macroalbuminuria (ACR >300 mg/g).
- Secondary or hereditary kidney disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Instituto de Atención Integral de Enfermedades Renales del Estado de Aguascalientes
Aguascalientes, Aguascalientes, 20180
About this study
Official title: Multimodal Intervention and Its Association With Reduced Dysbiosis and Inflammation in Early Chronic Kidney Disease in Young People: a Prospective Study
Chronic kidney disease (CKD) is a progressive condition associated with substantial morbidity, mortality, and healthcare costs. Early detection and timely intervention are critical to modify disease trajectory, particularly in adolescents and young adults. Emerging evidence supports the role of the gut-kidney axis in CKD progression, whereby intestinal dysbiosis contributes to systemic inflammation and accumulation of microbiota-derived uremic toxins. This randomized controlled clinical trial aims to evaluate whether a multimodal intervention consisting of a controlled diet, structured exercise, and a symbiotic administered for 180 days improves uremic toxin burden, systemic inflammation, and early renal outcomes compared with standard care plus placebo.
Read the detailed description
This is a prospective, randomized, controlled clinical trial with repeated measurements and longitudinal follow-up. Participants aged 14-35 years with early-stage CKD, defined by persistent albuminuria despite preserved glomerular filtration, will be recruited through an institutional renal screening program in Aguascalientes, Mexico. The intervention targets the gut-kidney axis through sustained lifestyle modification and microbiota modulation. The primary mechanistic hypothesis is that reducing intestinal dysbiosis will decrease microbiota-derived uremic toxins and systemic inflammation, potentially attenuating early markers of renal disease progression.
Written informed consent will be obtained from participants aged 18 years or older. For participants under 18 years of age, written assent will be obtained along with informed consent from a parent or legal guardian.
- Conditions
- Exercise, Diet Interventions, Symbiotic, CKD Stage 1, CKD Stage 3, CKD Stage 2
- Being tested
- symbiotic, Placebo
- Keywords
- CKD, exercise, symbiotic, diet
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
symbioticDietary supplement
- Lifestyle interventions (diet + exercise)
- Microbiota modulation with probiotics, prebiotics, and symbiotic
- It will be quantified using IL-1β, IL-6 and TNF-α for their role in the chronic inflammatory response associated with dysbiosis and accumulation of intestinal uremic metabolites described in CKD.
PlaceboOther
- Lifestyle interventions (diet + exercise) 2. Their role in the chronic inflammatory response associated with dysbiosis and accumulation of intestinal uremic metabolites described in CKD will be quantified using IL-1β, IL-6 and TNF-α. 3. placebo
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Intervention | Experimental | Participants will receive a controlled diet, a structured exercise program, and an oral symbiotic supplement administered once daily at a fixed dose for 180 days. Receives: Dietary Supplement: symbiotic |
| Control | Placebo comparator | Participants will receive the same controlled diet and structured exercise program plus an oral placebo indistinguishable from the symbiotic, administered once daily for 180 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gut-derived uremic toxin levels
Change in gut-derived uremic toxin levels (including indoxyl sulfate and p-cresyl sulfate), measured in serum, from baseline
Measured: 180 days
Primary Outcome Measure:
Change in gut-derived uremic toxin levels (including indoxyl sulfate and p-cresyl sulfate), measured in serum,
Measured: 180 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start25 Apr 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion3 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional (Clinical Trial) Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single-blind (Participant) Primary Purpose: Prevention Duration: 180 days
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centenario Hospital Miguel Hidalgo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karla Valencia Perez Hernandez, Centenario Hospital Miguel Hidalgo
- Investigators
- Karla Valencia V Pérez Hernández, nutritionist, Principal investigator, Centenario Hospital Miguel Hidalgo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483697
- Sponsor's protocol ID
- INAER-Nutri01
- Acronym
- CKD
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wehedy E, Shatat IF, Al Khodor S. The Human Microbiome in Chronic Kidney Disease: A Double-Edged Sword. Front Med (Lausanne). 2022 Jan 17;8:790783. doi: 10.3389/fmed.2021.790783. eCollection 2021.
PubMed 35111779Wakino S, Hasegawa K, Tamaki M, Minato M, Inagaki T. Kidney-Gut Axis in Chronic Kidney Disease: Therapeutic Perspectives from Microbiota Modulation and Nutrition. Nutrients. 2025 Jun 9;17(12):1961. doi: 10.3390/nu17121961.
PubMed 40573072Voroneanu L, Burlacu A, Brinza C, Covic A, Balan GG, Nistor I, Popa C, Hogas S, Covic A. Gut Microbiota in Chronic Kidney Disease: From Composition to Modulation towards Better Outcomes-A Systematic Review. J Clin Med. 2023 Mar 1;12(5):1948. doi: 10.3390/jcm12051948.
PubMed 36902734Swanson KS, Gibson GR, Hutkins R, Reimer RA, Reid G, Verbeke K, Scott KP, Holscher HD, Azad MB, Delzenne NM, Sanders ME. The International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of synbiotics. Nat Rev Gastroenterol Hepatol. 2020 Nov;17(11):687-701. doi: 10.1038/s41575-020-0344-2. Epub 2020 Aug 21.
PubMed 32826966Rysz J, Franczyk B, Lawinski J, Olszewski R, Cialkowska-Rysz A, Gluba-Brzozka A. The Impact of CKD on Uremic Toxins and Gut Microbiota. Toxins (Basel). 2021 Mar 31;13(4):252. doi: 10.3390/toxins13040252.
PubMed 33807343Perez-Torres A, Caverni-Munoz A, Gonzalez Garcia E. Mediterranean Diet and Chronic Kidney Disease (CKD): A Practical Approach. Nutrients. 2022 Dec 25;15(1):97. doi: 10.3390/nu15010097.
PubMed 36615755Noce A, Marchetti M, Marrone G, Di Renzo L, Di Lauro M, Di Daniele F, Albanese M, Di Daniele N, De Lorenzo A. Link between gut microbiota dysbiosis and chronic kidney disease. Eur Rev Med Pharmacol Sci. 2022 Mar;26(6):2057-2074. doi: 10.26355/eurrev_202203_28354.
PubMed 35363356Neale EP, Rosario VD, Probst Y, Beck E, Tran TB, Lambert K. Lifestyle Interventions, Kidney Disease Progression, and Quality of Life: A Systematic Review and Meta-analysis. Kidney Med. 2023 Apr 18;5(6):100643. doi: 10.1016/j.xkme.2023.100643. eCollection 2023 Jun.
PubMed 37235039Mitrovic M, Stankovic-Popovic V, Tolinacki M, Golic N, Sokovic Bajic S, Veljovic K, Nastasijevic B, Soldatovic I, Svorcan P, Dimkovic N. The Impact of Synbiotic Treatment on the Levels of Gut-Derived Uremic Toxins, Inflammation, and Gut Microbiome of Chronic Kidney Disease Patients-A Randomized Trial. J Ren Nutr. 2023 Mar;33(2):278-288. doi: 10.1053/j.jrn.2022.07.008. Epub 2022 Aug 19.
PubMed 35995418Chen L, Shi J, Ma X, Shi D, Qu H. Effects of Microbiota-Driven Therapy on Circulating Indoxyl Sulfate and P-Cresyl Sulfate in Patients with Chronic Kidney Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Adv Nutr. 2022 Aug 1;13(4):1267-1278. doi: 10.1093/advances/nmab149.
PubMed 34905018Liu C, Yang L, Wei W, Fu P. Efficacy of probiotics/synbiotics supplementation in patients with chronic kidney disease: a systematic review and meta-analysis of randomized controlled trials. Front Nutr. 2024 Aug 6;11:1434613. doi: 10.3389/fnut.2024.1434613. eCollection 2024.
PubMed 39166132Levin A, Ahmed SB, Carrero JJ, Foster B, Francis A, Hall RK, Herrington WG, Hill G, Inker LA, Kazancioglu R, Lamb E, Lin P, Madero M, McIntyre N, Morrow K, Roberts G, Sabanayagam D, Schaeffner E, Shlipak M, Shroff R, Tangri N, Thanachayanont T, Ulasi I, Wong G, Yang CW, Zhang L, Robinson KA, Wilson L, Wilson RF, Kasiske BL, Cheung M, Earley A, Stevens PE. Executive summary of the KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease: known knowns and known unknowns. Kidney Int. 2024 Apr;105(4):684-701. doi: 10.1016/j.kint.2023.10.016.
PubMed 38519239Kwon YJ, Joo YS, Yun HR, Lim LR, Yang J, Lee HS, Kim HM, Lee H, Lee JE, Lee JW. Safety and impact of the Mediterranean diet in patients with chronic kidney disease: a pilot randomized crossover trial. Front Nutr. 2024 Sep 4;11:1463502. doi: 10.3389/fnut.2024.1463502. eCollection 2024.
PubMed 39296514Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int. 2024 Apr;105(4S):S117-S314. doi: 10.1016/j.kint.2023.10.018. No abstract available.
PubMed 38490803Holle J, Bartolomaeus H. Gut-derived metabolites as treatment targets in chronic kidney disease-an avenue toward personalized medicine. Pediatr Nephrol. 2025 May;40(5):1505-1510. doi: 10.1007/s00467-024-06609-w. Epub 2025 Jan 16. No abstract available.
PubMed 39820506
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Intervention and Its Association With Reduced Dysbiosis and Inflammation in Early Chronic Kidney Disease in Young People: a Prospective Study
- ClinicalTrials.gov ID
- NCT07483697
- Acronym / sponsor ID
- CKD / INAER-Nutri01
- Conditions
- Exercise, Diet Interventions, Symbiotic, CKD Stage 1, CKD Stage 3, CKD Stage 2
- Keywords
- CKD, exercise, symbiotic, diet
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centenario Hospital Miguel HidalgoUniversity, hospital or other
- Study start
- 25 Apr 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 3 Nov 2026 (estimated)
- First posted
- 19 Mar 2026 (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.
Chronic kidney disease (CKD) is a progressive condition associated with substantial morbidity, mortality, and healthcare costs. Early detection and timely intervention are critical to modify disease trajectory, particularly in adolescents and young adults. Emerging evidence supports the role of the gut-kidney axis in CKD progression, whereby intestinal dysbiosis contributes to systemic inflammation and accumulation of microbiota-derived uremic toxins. This randomized controlled clinical trial aims to evaluate whether a multimodal intervention consisting of a controlled diet, structured exercise, and a symbiotic administered for 180 days improves uremic toxin burden, systemic inflammation, and early renal outcomes compared with standard care plus placebo.
Detailed description
This is a prospective, randomized, controlled clinical trial with repeated measurements and longitudinal follow-up. Participants aged 14-35 years with early-stage CKD, defined by persistent albuminuria despite preserved glomerular filtration, will be recruited through an institutional renal screening program in Aguascalientes, Mexico. The intervention targets the gut-kidney axis through sustained lifestyle modification and microbiota modulation. The primary mechanistic hypothesis is that reducing intestinal dysbiosis will decrease microbiota-derived uremic toxins and systemic inflammation, potentially attenuating early markers of renal disease progression.
Written informed consent will be obtained from participants aged 18 years or older. For participants under 18 years of age, written assent will be obtained along with informed consent from a parent or legal guardian.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Interventional (Clinical Trial) Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single-blind (Participant) Primary Purpose: Prevention Duration: 180 days
| Arm | Type | Receives |
|---|---|---|
| Multimodal Intervention | Experimental | Dietary Supplement: symbioticParticipants will receive a controlled diet, a structured exercise program, and an oral symbiotic supplement administered once daily at a fixed dose for 180 days. |
| Control | Placebo comparator | Other: PlaceboParticipants will receive the same controlled diet and structured exercise program plus an oral placebo indistinguishable from the symbiotic, administered once daily for 180 days. |
Who may qualify
- Ages
- 14 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Persistent albuminuria (ACR >30 and <300 mg/g).
- Estimated GFR >60 mL/min/1.73 m².
- No identifiable secondary cause of kidney disease.
Key exclusion criteria (4 listed)
- Hypoalbuminemia.
- Nephrotic syndrome.
- Persistent macroalbuminuria (ACR >300 mg/g).
- Secondary or hereditary kidney disease.
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 |
|---|---|---|
| symbiotic1. Lifestyle interventions (diet + exercise) 2. Microbiota modulation with probiotics, prebiotics, and symbiotic 3. It will be quantified using IL-1β, IL-6 and TNF-α for their role in the chronic inflammatory response associated with dysbiosis and accumulation of intestinal uremic metabolites described in CKD. | Dietary supplement | Multimodal Intervention |
| Placebo1. Lifestyle interventions (diet + exercise) 2. Their role in the chronic inflammatory response associated with dysbiosis and accumulation of intestinal uremic metabolites described in CKD will be quantified using IL-1β, IL-6 and TNF-α. 3. placebo | Other | Control |
Primary outcome
Change in gut-derived uremic toxin levels
Time frame: 180 days
Change in gut-derived uremic toxin levels (including indoxyl sulfate and p-cresyl sulfate), measured in serum, from baseline
Primary Outcome Measure:
Time frame: 180 days.
Change in gut-derived uremic toxin levels (including indoxyl sulfate and p-cresyl sulfate), measured in serum,
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Background: PubMed 35111779Wehedy E, Shatat IF, Al Khodor S. The Human Microbiome in Chronic Kidney Disease: A Double-Edged Sword. Front Med (Lausanne). 2022 Jan 17;8:790783. doi: 10.3389/fmed.2021.790783. eCollection 2021.
- Background: PubMed 40573072Wakino S, Hasegawa K, Tamaki M, Minato M, Inagaki T. Kidney-Gut Axis in Chronic Kidney Disease: Therapeutic Perspectives from Microbiota Modulation and Nutrition. Nutrients. 2025 Jun 9;17(12):1961. doi: 10.3390/nu17121961.
- Background: PubMed 36902734Voroneanu L, Burlacu A, Brinza C, Covic A, Balan GG, Nistor I, Popa C, Hogas S, Covic A. Gut Microbiota in Chronic Kidney Disease: From Composition to Modulation towards Better Outcomes-A Systematic Review. J Clin Med. 2023 Mar 1;12(5):1948. doi: 10.3390/jcm12051948.
- Background: PubMed 32826966Swanson KS, Gibson GR, Hutkins R, Reimer RA, Reid G, Verbeke K, Scott KP, Holscher HD, Azad MB, Delzenne NM, Sanders ME. The International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of synbiotics. Nat Rev Gastroenterol Hepatol. 2020 Nov;17(11):687-701. doi: 10.1038/s41575-020-0344-2. Epub 2020 Aug 21.
- Background: PubMed 33807343Rysz J, Franczyk B, Lawinski J, Olszewski R, Cialkowska-Rysz A, Gluba-Brzozka A. The Impact of CKD on Uremic Toxins and Gut Microbiota. Toxins (Basel). 2021 Mar 31;13(4):252. doi: 10.3390/toxins13040252.
- Background: PubMed 36615755Perez-Torres A, Caverni-Munoz A, Gonzalez Garcia E. Mediterranean Diet and Chronic Kidney Disease (CKD): A Practical Approach. Nutrients. 2022 Dec 25;15(1):97. doi: 10.3390/nu15010097.
- Background: PubMed 35363356Noce A, Marchetti M, Marrone G, Di Renzo L, Di Lauro M, Di Daniele F, Albanese M, Di Daniele N, De Lorenzo A. Link between gut microbiota dysbiosis and chronic kidney disease. Eur Rev Med Pharmacol Sci. 2022 Mar;26(6):2057-2074. doi: 10.26355/eurrev_202203_28354.
- Background: PubMed 37235039Neale EP, Rosario VD, Probst Y, Beck E, Tran TB, Lambert K. Lifestyle Interventions, Kidney Disease Progression, and Quality of Life: A Systematic Review and Meta-analysis. Kidney Med. 2023 Apr 18;5(6):100643. doi: 10.1016/j.xkme.2023.100643. eCollection 2023 Jun.
- Background: PubMed 35995418Mitrovic M, Stankovic-Popovic V, Tolinacki M, Golic N, Sokovic Bajic S, Veljovic K, Nastasijevic B, Soldatovic I, Svorcan P, Dimkovic N. The Impact of Synbiotic Treatment on the Levels of Gut-Derived Uremic Toxins, Inflammation, and Gut Microbiome of Chronic Kidney Disease Patients-A Randomized Trial. J Ren Nutr. 2023 Mar;33(2):278-288. doi: 10.1053/j.jrn.2022.07.008. Epub 2022 Aug 19.
- Background: PubMed 34905018Chen L, Shi J, Ma X, Shi D, Qu H. Effects of Microbiota-Driven Therapy on Circulating Indoxyl Sulfate and P-Cresyl Sulfate in Patients with Chronic Kidney Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Adv Nutr. 2022 Aug 1;13(4):1267-1278. doi: 10.1093/advances/nmab149.
- Background: PubMed 39166132Liu C, Yang L, Wei W, Fu P. Efficacy of probiotics/synbiotics supplementation in patients with chronic kidney disease: a systematic review and meta-analysis of randomized controlled trials. Front Nutr. 2024 Aug 6;11:1434613. doi: 10.3389/fnut.2024.1434613. eCollection 2024.
- Background: PubMed 38519239Levin A, Ahmed SB, Carrero JJ, Foster B, Francis A, Hall RK, Herrington WG, Hill G, Inker LA, Kazancioglu R, Lamb E, Lin P, Madero M, McIntyre N, Morrow K, Roberts G, Sabanayagam D, Schaeffner E, Shlipak M, Shroff R, Tangri N, Thanachayanont T, Ulasi I, Wong G, Yang CW, Zhang L, Robinson KA, Wilson L, Wilson RF, Kasiske BL, Cheung M, Earley A, Stevens PE. Executive summary of the KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease: known knowns and known unknowns. Kidney Int. 2024 Apr;105(4):684-701. doi: 10.1016/j.kint.2023.10.016.
- Registro Estatal Único de Enfermedad Renal Crónica del Estado de Aguascalientes: Prevalencia.Link provided by the sponsor.
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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.
Karla Valencia V Pérez Hernández, nutritionist principal investigator
Centenario Hospital Miguel Hidalgo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing symbiotic in people with Exercise and Diet Interventions, run by Centenario Hospital Miguel Hidalgo 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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 19 Mar 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 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karla Valencia V Pérez Hernández (+524491126729, valencia.iaier@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gut-derived uremic toxin levels (time frame: 180 days). 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 NCT07483697, which also lists 20 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 19 Mar 2026.