Iron Deficiency (ID)Phase 2ProMomsNCT07076849
Probiotic Supplementation in Optimizing Iron and Hematological Status Among Pregnant Females
A Phase 2 study testing Lactiplantibacillus plantarum 299v in people with Iron Deficiency (ID) and Pregnancy, run by University of Illinois at Chicago at 1 site in United States.
Trial summary
Maternal iron deficiency (ID) and iron deficiency anemia (IDA) is associated with maternal and infant mortality, spontaneous preterm birth, maternal postpartum hemorrhage, and neurocognitive defects in the neonate. Therefore, preventing maternal IDA in at-risk women is critical. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency (ID), Pregnancy
- What is being tested?
- Lactiplantibacillus plantarum 299v
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2026to 30 Nov 2030
- Phase
- Phase 2
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- singleton naturally conceived pregnancy;
- at risk of IDA [Hb 11.0 - 11.9 g/dL (first trimester) and Hb 10.5 - 11.5 g/dL (second trimester) based on new OB clinical complete blood count (CBC) results obtained from the EHR;
- 18 - 45 years old;
- 10-16 weeks GA;
- fluency in English to provide consent and complete study procedures;
- ability to provide consent;
- and ownership of a smartphone (currently more than 90% of our patient population at the CWH).
Who cannot join
- IDA or other nutritional anemia (i.e., diagnosed or suspected B12 or folate deficiency) based on new OB blood work that includes MCV and MCH to characterize the anemia;
- recent blood transfusion;
- autoimmune disorder (e.g., rheumatoid arthritis);
- inflammatory bowel disease;
- oral or IV antibiotic use within 2 months;
- previous spontaneous preterm birth;
Show all 12Show fewer
- history of bariatric surgery;
- malabsorptive disease;
- current hyperemesis;
- current eating disorder;
- hematologic disorder or trait carrier (e.g., hemochromatosis, β-thalassemia);
- current tobacco, alcohol or illicit drug use (Excluding marijuana).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois at Chicago
Chicago, Illinois, 60612
Tory deMartelly, MPH, 3123555119, vdemar2@uic.edu
About this study
Official title: Mechanistic Pathways of Probiotic Supplementation in Optimizing Iron and Hematological Status Among Pregnant Females at Risk of Iron Deficiency Anemia
Maternal iron deficiency (ID) and iron deficiency anemia (IDA) is associated with maternal and infant mortality, spontaneous preterm birth, maternal postpartum hemorrhage, and neurocognitive defects in the neonate. Therefore, preventing maternal IDA in at-risk women is critical. The standard approach to improving iron status in pregnancy (i.e., oral iron supplements) is suboptimal and gastrointestinal discomforts associated with this approach (i.e., constipation) impairs adherence. The incidence of ID (18%) and IDA (5%) in pregnant populations suggest alternative interventions are needed to optimize iron status in pregnancy. There is increasing evidence that consuming the probiotic Lactoplantibacillus plantarum 299v (LP299V®) can enhance dietary non-heme iron absorption by changes in the composition and metabolic patterns of gut microbiota that reduce intestinal pH, enhance mucin production and favor an anti-inflammatory milieu. This immunomodulatory effect may be important because inflammation stimulates hepatic production of hepcidin, a master regulator of systemic iron homeostasis, which inhibits iron flow into circulation from diet and body stores. Further, the effects of LP299V® may extend to the placenta. The investigators' team showed previously that maternal iron deficiency is associated with changes to placental iron metabolism with more iron sequestered in the placenta and less iron transferring to the fetus. Given its positive effects on maternal iron status, the investigators surmise that LP299V® supplementation will result in higher placenta protein expression of iron transporters, transferrin receptor-1 and ferrroportin-1, and lower placental iron accumulation/content. The primary goal of this study is to test the efficacy of this low-cost, safe, innovative approach to optimizing maternal iron status in individuals at risk for ID in pregnancy [Hb 11.0 - 11.9 g/dL (first trimester) and Hb 10.5 - 11.5 g/dL (second trimester) based on new OB clinical complete blood count (CBC) results obtained from the EHR] from 10-16 weeks gestational age (GA) until the time of labor. The investigators will also test the effects on neonatal (cord blood) iron status and (cord blood + newborn heel stick) Hb at birth and determine the effect of maternal LP299V® supplementation on the maternal gut microbiome, hepcidin-ferroportin axis and placenta iron and placenta transport of iron as its primary mechanisms of action. Finally, the investigators will explore the effect of maternal LP299V® supplementation on infant neurodevelopment at birth. This study is an essential first step toward evaluating if twice daily oral LP299V® is an efficacious, safe, inexpensive, and scalable clinical strategy for the prevention of maternal ID and its related complications in at-risk women.
- Conditions
- Iron Deficiency (ID), Pregnancy
- Being tested
- Lactiplantibacillus plantarum 299v, Placebo Capsule(s)
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactiplantibacillus plantarum 299vDietary supplement
Probiotic
Placebo Capsule(s)Other
Placebo control
| Study group | Role | What they receive |
|---|---|---|
| Lactiplantibacillus plantarum 299v (LP299V®) | Experimental | Probiotic Receives: Dietary Supplement: Lactiplantibacillus plantarum 299v |
| Control | Placebo comparator | Placebo capsule Receives: Other: Placebo Capsule(s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal hemoglobin from complete blood count (CBC) with differential
Venous blood draw
Measured: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Secondary outcomes (27)
Maternal iron deficiency anemia (IDA)
Hb <10.5 g/dL during second trimester and Hb <11 g/dL during third trimester
Measured: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Complete blood count (CBC) with differential (WBC, RBC, Hematocrit, MCV, MCH, MCHC, RDW, Platelet Count, MPV and Differential (Absolute and Percent - Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils)
Venous blood draw
Measured: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Maternal serum ferritin
Venous blood draw
Measured: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Maternal serum iron
Venous blood draw
Measured: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Maternal sTfR
Venous blood draw
Measured: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Maternal total body iron (TBI)
(TBI (mg/kg) = - [log(TfR/ferritin ratio) - 2.8229]/0.1207)
Measured: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Maternal hepcidin
Venous blood draw
Measured: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Maternal erythropoietin (EPO)
Venous blood draw
Measured: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Maternal circulating cytokines (interleukin-6 (IL-6), GM-CS, IL-2, IL-4, IL-8, IL-10, TNFα, and IFNγ
Venous blood draw
Measured: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Maternal C-reactive protein (CRP)
Venous blood draw
Measured: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Maternal Erythroferrone (ERFE)
Venous blood draw
Measured: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Maternal Erythroferrone (ERFE) Cord Complete blood count (CBC) with differential (WBC, RBC, Hematocrit, MCV, MCH, MCHC, RDW, Platelet Count, MPV and Differential (Absolute and Percent - Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils)
Cord blood draw
Measured: delivery
Cord serum ferritin
Cord blood draw
Measured: delivery
Cord serum iron
Cord blood draw
Measured: delivery
Cord sTfR
Cord blood draw
Measured: delivery
Cord total body iron (TBI)
(TBI (mg/kg) = - [log(TfR/ferritin ratio) - 2.8229]/0.1207)
Measured: delivery
Newborn heel stick
Blood spot
Measured: After delivery before baby released home
Placenta iron transporter (FPN-1 and TFR-1)
Western blot
Measured: delivery
Placenta iron quantification
Immunohistochemistry
Measured: delivery
Placenta tissue iron concentration
Inductively coupled plasma-mass spectrometry (ICP-MS)
Measured: delivery
Fecal abundance of A. muciniphila
Quantitative polymerase chain reaction (qPCR)
Measured: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Shot-gun sequencing and analysis (taxonomy and functional profiling)
MetaPhlAn4 and HUMAnN 2.0
Measured: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3)
Microbial mucin degrading enzymes
CaZymes
Measured: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3)
Stool pH
pH probe
Measured: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3)
Adverse pregnancy outcomes post-treatment and at delivery (clinical- EMR)
Adverse pregnancy outcomes post-treatment and at delivery (clinical-EMR)
Measured: delivery
Probiotic acceptance and tolerability
Daily capsule adherence Reported adverse health effects
Measured: 10-16 weeks GA, 14-20 weeks GA, 18-24 weeks GA, 22-28 weeks GA, 26-32 weeks GA, 30-36 weeks GA, 34-40 weeks GA, 38-40 weeks GA
Auditory Brainstem Response (ABR) testing
Interpeak latency I-V
Measured: -3 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Feb 2026
- Primary completion30 Oct 2030 (estimated)
- Study completion30 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency (ID)Studies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076849
- Sponsor's protocol ID
- 2025-0431
- Acronym
- ProMoms
- Status last verified
- Apr 2026
- First submitted
- 9 Jul 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic Pathways of Probiotic Supplementation in Optimizing Iron and Hematological Status Among Pregnant Females at Risk of Iron Deficiency Anemia
- ClinicalTrials.gov ID
- NCT07076849
- Acronym / sponsor ID
- ProMoms / 2025-0431
- Conditions
- Iron Deficiency (ID), Pregnancy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 30 Oct 2030 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 22 Jul 2025 (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.
Maternal iron deficiency (ID) and iron deficiency anemia (IDA) is associated with maternal and infant mortality, spontaneous preterm birth, maternal postpartum hemorrhage, and neurocognitive defects in the neonate. Therefore, preventing maternal IDA in at-risk women is critical. The standard approach to improving iron status in pregnancy (i.e., oral iron supplements) is suboptimal and gastrointestinal discomforts associated with this approach (i.e., constipation) impairs adherence. The incidence of ID (18%) and IDA (5%) in pregnant populations suggest alternative interventions are needed to optimize iron status in pregnancy. There is increasing evidence that consuming the probiotic Lactoplantibacillus plantarum 299v (LP299V®) can enhance dietary non-heme iron absorption by changes in the composition and metabolic patterns of gut microbiota that reduce intestinal pH, enhance mucin production and favor an anti-inflammatory milieu. This immunomodulatory effect may be important because inflammation stimulates hepatic production of hepcidin, a master regulator of systemic iron homeostasis, which inhibits iron flow into circulation from diet and body stores. Further, the effects of LP299V® may extend to the placenta. The investigators' team showed previously that maternal iron deficiency is associated with changes to placental iron metabolism with more iron sequestered in the placenta and less iron transferring to the fetus. Given its positive effects on maternal iron status, the investigators surmise that LP299V® supplementation will result in higher placenta protein expression of iron transporters, transferrin receptor-1 and ferrroportin-1, and lower placental iron accumulation/content. The primary goal of this study is to test the efficacy of this low-cost, safe, innovative approach to optimizing maternal iron status in individuals at risk for ID in pregnancy [Hb 11.0 - 11.9 g/dL (first trimester) and Hb 10.5 - 11.5 g/dL (second trimester) based on new OB clinical complete blood count (CBC) results obtained from the EHR] from 10-16 weeks gestational age (GA) until the time of labor. The investigators will also test the effects on neonatal (cord blood) iron status and (cord blood + newborn heel stick) Hb at birth and determine the effect of maternal LP299V® supplementation on the maternal gut microbiome, hepcidin-ferroportin axis and placenta iron and placenta transport of iron as its primary mechanisms of action. Finally, the investigators will explore the effect of maternal LP299V® supplementation on infant neurodevelopment at birth. This study is an essential first step toward evaluating if twice daily oral LP299V® is an efficacious, safe, inexpensive, and scalable clinical strategy for the prevention of maternal ID and its related complications in at-risk women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactiplantibacillus plantarum 299v (LP299V®) | Experimental | Dietary Supplement: Lactiplantibacillus plantarum 299vProbiotic |
| Control | Placebo comparator | Other: Placebo Capsule(s)Placebo capsule |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- singleton naturally conceived pregnancy;
- at risk of IDA [Hb 11.0 - 11.9 g/dL (first trimester) and Hb 10.5 - 11.5 g/dL (second trimester) based on new OB clinical complete blood count (CBC) results obtained from the EHR;
- 18 - 45 years old;
- 10-16 weeks GA;
- fluency in English to provide consent and complete study procedures;
Key exclusion criteria (12 listed)
- IDA or other nutritional anemia (i.e., diagnosed or suspected B12 or folate deficiency) based on new OB blood work that includes MCV and MCH to characterize the anemia;
- recent blood transfusion;
- autoimmune disorder (e.g., rheumatoid arthritis);
- inflammatory bowel disease;
- oral or IV antibiotic use within 2 months;
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 |
|---|---|---|
| Lactiplantibacillus plantarum 299vProbiotic | Dietary supplement | Lactiplantibacillus plantarum 299v (LP299V®) |
| Placebo Capsule(s)Placebo control | Other | Control |
Primary outcome
Maternal hemoglobin from complete blood count (CBC) with differential
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Venous blood draw
27 secondary outcomes
Maternal iron deficiency anemia (IDA)
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Complete blood count (CBC) with differential (WBC, RBC, Hematocrit, MCV, MCH, MCHC, RDW, Platelet Count, MPV and Differential (Absolute and Percent - Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils)
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Maternal serum ferritin
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Maternal serum iron
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Maternal sTfR
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Maternal total body iron (TBI)
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Maternal hepcidin
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Maternal erythropoietin (EPO)
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Maternal circulating cytokines (interleukin-6 (IL-6), GM-CS, IL-2, IL-4, IL-8, IL-10, TNFα, and IFNγ
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Maternal C-reactive protein (CRP)
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Maternal Erythroferrone (ERFE)
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Maternal Erythroferrone (ERFE) Cord Complete blood count (CBC) with differential (WBC, RBC, Hematocrit, MCV, MCH, MCHC, RDW, Platelet Count, MPV and Differential (Absolute and Percent - Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils)
Time frame: delivery
Cord serum ferritin
Time frame: delivery
Cord serum iron
Time frame: delivery
Cord sTfR
Time frame: delivery
Cord total body iron (TBI)
Time frame: delivery
Newborn heel stick
Time frame: After delivery before baby released home
Placenta iron transporter (FPN-1 and TFR-1)
Time frame: delivery
Placenta iron quantification
Time frame: delivery
Placenta tissue iron concentration
Time frame: delivery
Fecal abundance of A. muciniphila
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Shot-gun sequencing and analysis (taxonomy and functional profiling)
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3)
Microbial mucin degrading enzymes
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3)
Stool pH
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3)
Adverse pregnancy outcomes post-treatment and at delivery (clinical- EMR)
Time frame: delivery
Probiotic acceptance and tolerability
Time frame: 10-16 weeks GA, 14-20 weeks GA, 18-24 weeks GA, 22-28 weeks GA, 26-32 weeks GA, 30-36 weeks GA, 34-40 weeks GA, 38-40 weeks GA
Auditory Brainstem Response (ABR) testing
Time frame: -3 days postpartum
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 1 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Iron Deficiency (ID)
Recruiting
Infusing Needed Iron to Target Insufficiency in Adults Treated for Evidence of Heart Failure
Iron Deficiency (ID), Heart Failure
RecruitingPhase 4
The Prevalence of Iron Deficiency and the Effectiveness of Ferinject® in Patients With HFpEF (ID-HFpEF)
Chronic Heart Failure, Iron Deficiency, Latent
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lactiplantibacillus plantarum 299v in people with Iron Deficiency (ID) and Pregnancy, run by University of Illinois at Chicago at 1 site in United States.
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 12 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: looking for participants now, as of the sponsor's last update on 1 May 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 States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Mary Dawn Koenig, PhD, RN, CNM (312-996-7982, marydh@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal hemoglobin from complete blood count (CBC) with differential (time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)). 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 1 May 2026.