BoneFERMBONENCT07645885
Fermented Foods and Bone Health: Investigating the Gut-Bone Axis in Premenopausal Vegan Women
A study testing Fermented Plant-Based Foods and Non-Fermented Plant-Based Foods in people with Bone and Bone Health, run by Isabelle Herter-Aeberli at 2 sites in 2 countries.
Trial summary
Plant-based diets are increasingly adopted for health and environmental reasons, but they are associated with lower bone mineral density, higher fracture risk, and elevated bone turnover markers, particularly in women. Read more about this study
- Who is it for?
- Ages 28 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bone, Bone Health
- What is being tested?
- Fermented Plant-Based Foods and Non-Fermented Plant-Based Foods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 31 May 2026to 31 May 2027
- 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 28 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female, aged 28-43years.
- Body mass index (BMI) between 18.5 and 24.9 kg/m².
- Premenopausal, with regular menstrual cycles. *
- Adherence to a vegan diet for ≥1 year, confirmed by questionnaire.
- Willingness to consume both fermented and non-fermented plant-based study foods.
- Ability to comply with all study procedures, including run-in, washout, sample collection, and clinic visits.
- Signed written and oral informed consent.
- Regular menstrual cycles are defined as spontaneous menstrual bleeding occurring every 21-35 days, with cycle-to-cycle variability not exceeding 7-9 days over the prior three months, and bleeding duration of 3-8 days, in the absence of hormonal contraception or endocrine disorders.
Who cannot join
- Chronic diseases or conditions affecting bone metabolism (e.g., osteoporosis, thyroid disorders, chronic kidney and liver disease, menstrual cycles disorders affecting bone health, conditions associated with malabsorption).
- History of diagnosed eating disorders.
- Chronic inflammatory or gastrointestinal diseases (e.g., IBD, celiac disease).
- Recent antibiotic use (within 3 months prior to screening).
- Use of Vitamin D supplements exceeding 2000 IU/day.
- Abnormal DXA results (T-score ≤ -2.5).
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- Pregnancy, intention to become pregnant, or lactation during the course of the study
- Use of hormonal contraceptives.
- Use of medications influencing bone metabolism (e.g., glucocorticoids, antiresorptives).
- BMI <18.5 or >24.9 kg/m².
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the studies, e.g. due to language problems, psychological disorders, dementia, etc. of the participant or anticipated prolonged absence (e.g. extended travel).
- Participation in another clinical study within the last 3 months.
- Known allergy or intolerance to study foods.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Czechia1 site
Third Faculty of Medicine
Prague, Prague, 100 00
Jan Gojda, Prof. Dr., +420267163031, jan.gojda@lf3.cuni.cz
Switzerland1 site
Swiss Federal Institute of Technology
Zurich, Canton of Zurich, 8092
Isabelle Herter-Aeberli, PhD, +41 44 632 74 81, isabelle.herter@hest.ethz.ch
Isabelle Herter-Aeberli, PhD
About this study
Plant-based diets are increasingly adopted for health and environmental reasons, but they are associated with lower bone mineral density, higher fracture risk, and elevated bone turnover markers, particularly in women. These effects are partly explained by lower intakes of calcium and zinc, and higher concentrations of phytates and oxalates, substances that inhibit mineral absorption from plant foods. Evidence-based dietary strategies to support bone health in vegan populations beyond supplementation remain limited.
Fermented plant-based foods may help address this gap through two complementary mechanisms: first, by delivering live microorganisms that beneficially modulate gut microbiota and promote the production of short-chain fatty acids, which support mineral absorption and reduce bone resorption, and second, by reducing antinutritional factors such as phytates during microbial fermentation, thereby improving mineral bioavailability.
This study investigates whether the daily consumption of fermented plant-based foods, specifically lacto-fermented vegetables, calcium-fortified plant-based yogurt alternatives with live cultures, and Rhizopus-fermented tempeh, reduces bone resorption and improves calcium metabolism in premenopausal women following a vegan diet. Participants will follow each dietary condition (fermented or matched non-fermented control foods) for 12 weeks in randomized order, separated by an 8-week washout period. Blood, urine, and stool samples are collected at each study visit to assess bone turnover markers, gut microbiota composition, short-chain fatty acid production, inflammatory markers, and a range of metabolic and nutritional parameters.
Read the detailed description
Vegan diets are associated with lower bone mineral density and elevated fracture risk, partly due to reduced intake of calcium and zinc and higher concentrations of phytates and oxalates, which inhibit intestinal mineral absorption. Emerging evidence suggests that the gut microbiota plays a key regulatory role in bone metabolism through the gut-bone axis, primarily via production of short-chain fatty acids (SCFAs), which enhance mineral absorption, modulate immune responses, and suppress osteoclastogenesis. Fermented plant-based foods may beneficially modulate this axis by delivering live microorganisms and by reducing antinutritional factors through microbial phytase activity, thereby improving mineral bioavailability.
FERMBONE is a randomized, controlled, open-label, two-period crossover trial conducted at two sites: ETH Zürich (Switzerland) and Královské Vinohrady University Hospital (Prague, Czech Republic). Fifty premenopausal vegan women are enrolled (25 per site).
Study Design and phases:
After a screening visit, participants attend a baseline visit (week 0) to assess baseline characteristics and enter a 4-week run-in period during which fermented plant-based foods are excluded from the diet to standardize gut microbiota baseline. Participants are then randomized to one of two sequences: fermented foods in Phase I (weeks 4-16) followed by control foods in Phase II (weeks 24-36), or the reverse. The two 12-week intervention phases are separated by an 8-week washout period (weeks 16-24) during which the same dietary restrictions as in the run-in apply.
Intervention:
The fermented food intervention comprises three categories consumed daily: calcium-fortified fermented plant-based yogurt alternatives with live cultures, lacto-fermented vegetables including sauerkraut and kimchi, and Rhizopus-fermented tempeh, for a minimum combined total of 14 portions per week across at least two categories daily. The matched control condition consists of non-fermented plant-based equivalents: calcium-fortified plant-based milk, fresh raw vegetables, and cooked non-fermented legumes, matched at the group level for portion size, energy, protein, and calcium content. All study foods are commercially available and provided to participants.
Assessments:
Study visits are conducted at baseline and at the beginning and end of each intervention phase (weeks 0, 4, 16, 24, 36). At each visit, fasting venous blood samples, morning spot urine, and stool samples are obtained. Anthropometric measurements, blood pressure, standardized questionnaires, and a weighed 3-day dietary record are completed at each visit. A single DXA scan is performed during the run-in period to assess the baseline bone density.
Biological analyses:
Bone turnover markers (CTX, P1NP, ALP) and endocrine regulators (PTH, 25(OH)D) are measured from fasting serum. Further, urinary calcium, phosphate, and creatinine are measured. Gut microbiota composition is assessed by whole-genome metagenomic sequencing and fecal SCFAs are quantified by targeted metabolomics. Inflammatory and intestinal integrity markers (CRP, AGP, IL-6, iFABP), fecal pH and calprotectin, hemoglobin, and DNA methylation-based epigenetic aging markers are analyzed along with iron status markers (ferritin, soluble transferrin receptor) and metabolic parameters (glucose, insulin, lipid profile).
- Conditions
- Bone, Bone Health
- Being tested
- Fermented Plant-Based Foods, Non-Fermented Plant-Based Foods
- Keywords
- Fermented foods, Bone health, Gut microbiota, Gut-bone axis, Premenopausal women, Plant-based diet, Vegan diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented Plant-Based FoodsOther
Daily consumption of three categories of fermented plant-based foods for 12 weeks: lacto-fermented vegetables, fermented plant-based yogurt alternatives with live cultures and calcium fortification, and Rhizopus-fermented tempeh. Minimum combined weekly target: 14 portions.
Non-Fermented Plant-Based FoodsOther
Daily consumption of non-fermented plant-based equivalents for 12 weeks, matched to the intervention arm for portion size, energy, protein, and calcium content: non-fermented calcium-fortified plant-based milk, fresh raw vegetables, and cooked non-fermented legumes.
| Study group | Role | What they receive |
|---|---|---|
| Fermented Plant-Based Foods | Experimental | Participants consume three categories of fermented plant-based foods daily for 12 weeks: lacto-fermented vegetables, fermented plant-based yogurt alternatives with live cultures and calcium fortification, and Rhizopus-fermented tempeh, with a minimum combined weekly target of 14 portions. Receives: Other: Fermented Plant-Based Foods |
| Non-Fermented Control Foods | Active comparator | Participants consume non-fermented plant-based equivalents matched for portion size, energy, protein, and calcium content for 12 weeks: non-fermented calcium-fortified plant-based milk, fresh raw vegetables, and cooked non-fermented legumes. Receives: Other: Non-Fermented Plant-Based Foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting serum CTX concentration
Within-subject difference in fasting serum C-terminal telopeptide of type I collagen (CTX) concentration between the end of the fermented food intervention phase and the end of the matched control phase, measured by electrochemiluminescence immunoassay (ECLIA).
Measured: Baseline (Week 0), at the beginning and end of each 12-week intervention phase (Weeks 4, 16, 24, and 36)
Secondary outcomes (6)
Fasting serum P1NP concentration
Serum procollagen type 1 N-terminal propeptide (P1NP), a marker of bone formation reflecting osteoblast activity, measured by ECLIA.
Measured: Baseline (Week 0), at the beginning and end of each 12-week intervention phase (Weeks 4, 16, 24, and 36)
Fasting serum alkaline phosphatase (ALP) concentration
Serum alkaline phosphatase (ALP), a non-specific marker of bone formation reflecting osteoblast activity, measured by standard clinical chemistry methods.
Measured: Baseline (Week 0), at the beginning and end of each 12-week intervention phase (Weeks 4, 16, 24, and 36)
Fasting serum parathyroid hormone (PTH) concentration
Parathyroid hormone (PTH), an endocrine regulator of calcium homeostasis, measured by immunoassay at the University Hospital Zurich from fasting serum (ng/l).
Measured: Baseline (Week 0), at the beginning and end of each 12-week intervention phase (Weeks 4, 16, 24, and 36)
Fasting serum 25-hydroxyvitamin D (25(OH)D) concentration
Serum 25-hydroxyvitamin D (25(OH)D), a marker of vitamin D status, measured by immunoassay at the University Hospital Zurich (nmol/l).
Measured: Baseline (Week 0), at the beginning and end of each 12-week intervention phase (Weeks 4, 16, 24, and 36)
Urinary calcium-to-creatinine ratio (CCR)
Calcium-to-creatinine ratio from morning spot urine samples, reflecting renal calcium handling and dietary calcium absorption.
Measured: Baseline (Week 0); Week 4, Week 16, Week 24, Week 36
Urinary phosphate-to-creatinine ratio
Phosphate-to-creatinine ratio from morning spot urine samples, reflecting renal phosphate handling.
Measured: Baseline (Week 0); Week 4, Week 16, Week 24, Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start31 May 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BoneStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isabelle Herter-Aeberli
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, Philhuman Foundation, Czech Science Foundation, Charles University, Czech Republic
- Responsible party
- Sponsor-investigator, Isabelle Herter-Aeberli, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645885
- Sponsor's protocol ID
- 2026-00984
- Acronym
- FERMBONE
- Status last verified
- Jun 2026
- First submitted
- 22 May 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Can be shared upon reasonable request and in compliance with ethical regulations.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fermented Foods and Bone Health: Investigating the Gut-Bone Axis in Premenopausal Vegan Women
- ClinicalTrials.gov ID
- NCT07645885
- Acronym / sponsor ID
- FERMBONE / 2026-00984
- Conditions
- Bone, Bone Health
- Keywords
- Fermented foods, Bone health, Gut microbiota, Gut-bone axis, Premenopausal women, Plant-based diet, Vegan diet
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Isabelle Herter-AeberliUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, Philhuman Foundation, Czech Science Foundation, Charles University, Czech Republic
- Study start
- 31 May 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 12 Jun 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.
Plant-based diets are increasingly adopted for health and environmental reasons, but they are associated with lower bone mineral density, higher fracture risk, and elevated bone turnover markers, particularly in women. These effects are partly explained by lower intakes of calcium and zinc, and higher concentrations of phytates and oxalates, substances that inhibit mineral absorption from plant foods. Evidence-based dietary strategies to support bone health in vegan populations beyond supplementation remain limited.
Fermented plant-based foods may help address this gap through two complementary mechanisms: first, by delivering live microorganisms that beneficially modulate gut microbiota and promote the production of short-chain fatty acids, which support mineral absorption and reduce bone resorption, and second, by reducing antinutritional factors such as phytates during microbial fermentation, thereby improving mineral bioavailability.
This study investigates whether the daily consumption of fermented plant-based foods, specifically lacto-fermented vegetables, calcium-fortified plant-based yogurt alternatives with live cultures, and Rhizopus-fermented tempeh, reduces bone resorption and improves calcium metabolism in premenopausal women following a vegan diet. Participants will follow each dietary condition (fermented or matched non-fermented control foods) for 12 weeks in randomized order, separated by an 8-week washout period. Blood, urine, and stool samples are collected at each study visit to assess bone turnover markers, gut microbiota composition, short-chain fatty acid production, inflammatory markers, and a range of metabolic and nutritional parameters.
Detailed description
Vegan diets are associated with lower bone mineral density and elevated fracture risk, partly due to reduced intake of calcium and zinc and higher concentrations of phytates and oxalates, which inhibit intestinal mineral absorption. Emerging evidence suggests that the gut microbiota plays a key regulatory role in bone metabolism through the gut-bone axis, primarily via production of short-chain fatty acids (SCFAs), which enhance mineral absorption, modulate immune responses, and suppress osteoclastogenesis. Fermented plant-based foods may beneficially modulate this axis by delivering live microorganisms and by reducing antinutritional factors through microbial phytase activity, thereby improving mineral bioavailability.
FERMBONE is a randomized, controlled, open-label, two-period crossover trial conducted at two sites: ETH Zürich (Switzerland) and Královské Vinohrady University Hospital (Prague, Czech Republic). Fifty premenopausal vegan women are enrolled (25 per site).
Study Design and phases:
After a screening visit, participants attend a baseline visit (week 0) to assess baseline characteristics and enter a 4-week run-in period during which fermented plant-based foods are excluded from the diet to standardize gut microbiota baseline. Participants are then randomized to one of two sequences: fermented foods in Phase I (weeks 4-16) followed by control foods in Phase II (weeks 24-36), or the reverse. The two 12-week intervention phases are separated by an 8-week washout period (weeks 16-24) during which the same dietary restrictions as in the run-in apply.
Intervention:
The fermented food intervention comprises three categories consumed daily: calcium-fortified fermented plant-based yogurt alternatives with live cultures, lacto-fermented vegetables including sauerkraut and kimchi, and Rhizopus-fermented tempeh, for a minimum combined total of 14 portions per week across at least two categories daily. The matched control condition consists of non-fermented plant-based equivalents: calcium-fortified plant-based milk, fresh raw vegetables, and cooked non-fermented legumes, matched at the group level for portion size, energy, protein, and calcium content. All study foods are commercially available and provided to participants.
Assessments:
Study visits are conducted at baseline and at the beginning and end of each intervention phase (weeks 0, 4, 16, 24, 36). At each visit, fasting venous blood samples, morning spot urine, and stool samples are obtained. Anthropometric measurements, blood pressure, standardized questionnaires, and a weighed 3-day dietary record are completed at each visit. A single DXA scan is performed during the run-in period to assess the baseline bone density.
Biological analyses:
Bone turnover markers (CTX, P1NP, ALP) and endocrine regulators (PTH, 25(OH)D) are measured from fasting serum. Further, urinary calcium, phosphate, and creatinine are measured. Gut microbiota composition is assessed by whole-genome metagenomic sequencing and fecal SCFAs are quantified by targeted metabolomics. Inflammatory and intestinal integrity markers (CRP, AGP, IL-6, iFABP), fecal pH and calprotectin, hemoglobin, and DNA methylation-based epigenetic aging markers are analyzed along with iron status markers (ferritin, soluble transferrin receptor) and metabolic parameters (glucose, insulin, lipid profile).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fermented Plant-Based Foods | Experimental | Other: Fermented Plant-Based FoodsParticipants consume three categories of fermented plant-based foods daily for 12 weeks: lacto-fermented vegetables, fermented plant-based yogurt alternatives with live cultures and calcium fortification, and Rhizopus-fermented tempeh, with a minimum combined weekly target of 14 portions. |
| Non-Fermented Control Foods | Active comparator | Other: Non-Fermented Plant-Based FoodsParticipants consume non-fermented plant-based equivalents matched for portion size, energy, protein, and calcium content for 12 weeks: non-fermented calcium-fortified plant-based milk, fresh raw vegetables, and cooked non-fermented legumes. |
Who may qualify
- Ages
- 28 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Female, aged 28-43years.
- Body mass index (BMI) between 18.5 and 24.9 kg/m².
- Premenopausal, with regular menstrual cycles. *
- Adherence to a vegan diet for ≥1 year, confirmed by questionnaire.
- Willingness to consume both fermented and non-fermented plant-based study foods.
Key exclusion criteria (14 listed)
- Chronic diseases or conditions affecting bone metabolism (e.g., osteoporosis, thyroid disorders, chronic kidney and liver disease, menstrual cycles disorders affecting bone health, conditions associated with malabsorption).
- History of diagnosed eating disorders.
- Chronic inflammatory or gastrointestinal diseases (e.g., IBD, celiac disease).
- Recent antibiotic use (within 3 months prior to screening).
- Use of Vitamin D supplements exceeding 2000 IU/day.
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 |
|---|---|---|
| Fermented Plant-Based FoodsDaily consumption of three categories of fermented plant-based foods for 12 weeks: lacto-fermented vegetables, fermented plant-based yogurt alternatives with live cultures and calcium fortification, and Rhizopus-fermented tempeh. Minimum combined weekly target: 14 portions. | Other | Fermented Plant-Based Foods |
| Non-Fermented Plant-Based FoodsDaily consumption of non-fermented plant-based equivalents for 12 weeks, matched to the intervention arm for portion size, energy, protein, and calcium content: non-fermented calcium-fortified plant-based milk, fresh raw vegetables, and cooked non-fermented legumes. | Other | Non-Fermented Control Foods |
Primary outcome
Fasting serum CTX concentration
Time frame: Baseline (Week 0), at the beginning and end of each 12-week intervention phase (Weeks 4, 16, 24, and 36)
Within-subject difference in fasting serum C-terminal telopeptide of type I collagen (CTX) concentration between the end of the fermented food intervention phase and the end of the matched control phase, measured by electrochemiluminescence immunoassay (ECLIA).
6 secondary outcomes
Fasting serum P1NP concentration
Time frame: Baseline (Week 0), at the beginning and end of each 12-week intervention phase (Weeks 4, 16, 24, and 36)
Fasting serum alkaline phosphatase (ALP) concentration
Time frame: Baseline (Week 0), at the beginning and end of each 12-week intervention phase (Weeks 4, 16, 24, and 36)
Fasting serum parathyroid hormone (PTH) concentration
Time frame: Baseline (Week 0), at the beginning and end of each 12-week intervention phase (Weeks 4, 16, 24, and 36)
Fasting serum 25-hydroxyvitamin D (25(OH)D) concentration
Time frame: Baseline (Week 0), at the beginning and end of each 12-week intervention phase (Weeks 4, 16, 24, and 36)
Urinary calcium-to-creatinine ratio (CCR)
Time frame: Baseline (Week 0); Week 4, Week 16, Week 24, Week 36
Urinary phosphate-to-creatinine ratio
Time frame: Baseline (Week 0); Week 4, Week 16, Week 24, Week 36
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 12 Jun 2026.
- Individual participant dataSharing planned: Undecided. Can be shared upon reasonable request and in compliance with ethical regulations.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fermented Plant-Based Foods and Non-Fermented Plant-Based Foods in people with Bone and Bone Health, run by Isabelle Herter-Aeberli at 2 sites in 2 countries.
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 8 inclusion and 14 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 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia, Switzerland. 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?
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 Isabelle Herter-Aeberli, PhD (+41 44 632 74 81, isabelle.herter@hest.ethz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting serum CTX concentration (time frame: Baseline (Week 0), at the beginning and end of each 12-week intervention phase (Weeks 4, 16, 24, and 36)). 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 12 Jun 2026.