Iron-deficiencyNCT03646487
A Randomized Placebo Controlled Pilot Study of Probiotic Supplementation in At-risk Pregnant Women
A study testing Probiotic LP299v 10x10 colony forming units in capsule form in people with Iron-deficiency and Pregnancy, High Risk, run by University of Illinois at Chicago at 1 site in United States.
Trial summary
The goal of this randomized supplementation feasibility trial is to learn about the feasibility and preliminary efficacy of the probiotic, lactobacillus plantarum 299v (Lp299v), in pregnant individuals at-risk for iron deficiency anemia. 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, Pregnancy, High Risk, Stress, Psychological
- What is being tested?
- Probiotic LP299v 10x10 colony forming units in capsule form
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2018to 21 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- a 1st trimester hemoglobin (Hb) of 10.0 - 11.9 g/dl demonstrating ID or risk for prenatal ID
- singleton
- naturally conceived pregnancy
- < 20 weeks gestation
- 18 - 45 years of age
- sufficient fluency in English to complete study forms
- refrain from non-study dietary and pre-/probiotic supplements while enrolled in the study
Who cannot join
- oral antibiotic use within the past 2 months
- autoimmune disease
- infection
- receiving steroid treatment
- bariatric surgery
- inflammatory bowel disease
Show all 11Show fewer
- hyperemesis
- hematologic disorder (e.g., sickle cell disease)
- current tobacco use
- substance abuse in the last 6 months
- other chronic disorders such as type 2 diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: "Pro-Moms" - Mitigating the Effects of Structural Violence on Maternal Iron Status: a Randomized Placebo Controlled Pilot Study of Probiotic Supplementation in At-risk Pregnant Women
The goal of this randomized supplementation feasibility trial is to learn about the feasibility and preliminary efficacy of the probiotic, lactobacillus plantarum 299v (Lp299v), in pregnant individuals at-risk for iron deficiency anemia.
The main questions it aims to answer are:
Read more
- Is daily oral Lp299v a feasible and tolerable intervention for pregnant individuals to uptake?
- Does daily oral Lp299v in pregnancy impact maternal and neonatal cord hematological and iron status parameters?
Participants will be randomly assigned to one of two treatment groups: daily intake or probiotic Lp299v + prenatal vitamin with iron or placebo + prenatal vitamin with iron from 15-20 weeks of gestation through delivery.
Researchers will compare the two treatment groups to see if there is a difference in the feasibility of the intervention and the preliminary efficacy on maternal and neonatal cord hematological and iron status parameters.
Read the detailed description
The most prevalent micronutrient deficiency in the United States (U.S.) is iron; a large majority of cases of iron deficiency (ID) and iron deficiency anemia (IDA) occur among pregnant women. During pregnancy, maternal iron stores are used for the growing fetus, maternal red blood cell (RBC) expansion, and placental growth and development, thus increasing the risk for ID and IDA. Across all trimesters of pregnancy in the U.S., it is estimated that 18% of individuals have ID and 5% have IDA, and within the third trimester, the prevalence of ID exceeds 27%. Prevalence of IDA is even greater among those who identify as Black or low-income. Maternal ID and IDA are associated with increased risk of preterm birth, low infant birth weight, maternal and fetal mortality, and irreversible infant neurocognitive defects. To meet this increasing requirement for iron and to optimize maternal iron nutrition, the Recommended Dietary Allowance for pregnancy is 27 mg/day of iron. However, given the continued high rates of maternal ID and IDA and only modest adherence to daily prenatal vitamins containing iron, alternative approaches to optimizing iron nutrition in pregnancy are needed.
Research has shown that one-time or short-term dosing of the probiotic Lactobacillus plantarum 299v (Lp299v) enhances iron absorption in non-pregnant populations. However, few studies have examined the effect of long-term supplementation on body iron stores. While probiotics are considered safe to consume in pregnancy, only one Lp299v supplementation trial has been conducted during the gestational period to evaluate its effects on maternal iron stores and risk of IDA. This study, among iron-sufficient pregnant Swedish women, showed a significantly lower decline in iron stores and a significantly lower prevalence of IDA in the third trimester among those randomized to Lp299v compared to standard care control.
These results offer potential positive effects for the role of Lp299v in maintaining maternal iron status among those starting pregnancy with sufficient iron stores and who receive care in a decentralized publicly funded healthcare system. However, no studies have evaluated the effect of Lp299v on maternal iron status among individuals at risk for IDA in pregnancy in the U.S., nor have studies extended findings to neonatal iron status. Moreover, it is unknown if positive feasibility and preliminary efficacy would persist in a U.S.-based health care setting with racially, ethnically, and socioeconomically diverse pregnant individuals. Therefore, the objectives of this study were as follows. First and foremost, we examined the feasibility of daily oral Lp299v maternal supplementation taken from the early second trimester through birth. Second, we explored the preliminary efficacy of Lp299v intake on maternal (at-risk for IDA defined as hemoglobin (Hb) between 10.0-12.0 g/dL) and neonatal cord hematological and iron status parameters compared to controls in an urban U.S. academic medical center with a racially, ethnically, and socioeconomically diverse patient population.
- Conditions
- Iron-deficiency, Pregnancy, High Risk, Stress, Psychological
- Being tested
- Probiotic LP299v 10x10 colony forming units in capsule form, Placebo in capsule form
- Keywords
- pregnancy, iron status, structural violence
- Medical subject headings
- Anemia, Iron-Deficiency, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic LP299v 10x10 colony forming units in capsule formDietary supplement
Daily lactobacillus plantarum (LP299v) 10x10 colony forming units in capsule form
Placebo in capsule formOther
Daily placebo in capsule form
| Study group | Role | What they receive |
|---|---|---|
| Probiotic LP299v | Experimental | Women will receive 1 LP299v (10x10 colony forming units) in capsule form and 1 standard prenatal supplement in tablet form daily beginning at 15 weeks gestation through delivery. Receives: Dietary Supplement: Probiotic LP299v 10x10 colony forming units in capsule form |
| Placebo | Placebo comparator | Women will receive 1 placebo in capsule form and 1 standard prenatal supplement in table form daily beginning at 15 weeks gestation through delivery. Receives: Other: Placebo in capsule form |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Adherence to the Supplement Regimen
Mean adherence to the supplement regimen using Pillsy smart bottles and standard pill counts.
Measured: 15 weeks gestation through delivery, an average of 25 weeks
Secondary outcomes (15)
Number of Treatment-emergent Adverse Events Related to GI Symptoms
Adverse events were captured using the Maternal Adherence Form beginning with the first pill refill visit through delivery. number of participants reporting adverse GI events
Measured: 15 weeks gestation through delivery, an average of 25 weeks
Maternal Hemoglobin
change in mean maternal serum hemoglobin (g/dl) from baseline to delivery
Measured: Assessed at baseline (i.e., 15-20 weeks gestation) through delivery; mean change from baseline to delivery is reported.
Maternal Hematocrit
Change in mean maternal serum hematocrit (%) from baseline to delivery
Measured: Assessed at baseline (i.e., 15-20 weeks gestation) through delivery; mean change from baseline to delivery is reported.
Maternal Iron
change in mean maternal serum iron (µg/dL) from baseline to delivery
Measured: Assessed at baseline (i.e., 15-20 weeks gestation) through delivery; mean change from baseline to delivery is reported.
Maternal Total Iron Binding Capacity
change in mean maternal total iron binding capacity (µmol/L) from baseline to delivery
Measured: Assessed at baseline (i.e., 15-20 weeks gestation) through delivery; mean change from baseline to delivery is reported.
Maternal Serum Ferritin
change in mean maternal serum ferritin (ng/mL) from baseline to delivery
Measured: Assessed at baseline (i.e., 15-20 weeks gestation) through delivery; mean change from baseline to delivery is reported.
Maternal Transferrin Saturation
change in mean maternal transferrin saturation (%) from baseline to delivery
Measured: Assessed at baseline (i.e., 15-20 weeks gestation) through delivery; mean change from baseline to delivery is reported.
Maternal High-sensitivity C-reactive Protein (Hs-CRP)
change in mean maternal high-sensitivity C-reactive protein (hs-CRP) (mg/L) from baseline to delivery
Measured: Assessed at baseline (i.e., 15-20 weeks gestation) through delivery; mean change from baseline to delivery is reported.
Maternal Iron Deficiency Anemia
Number of participants who had iron deficiency anemia (IDA) at delivery. Hemoglobin, obtained from the Complete Blood Count, was used to define trimester-specific maternal IDA, with a downward correction of 0.8 g/dL for Black women. At the time of the study, it was recommended to use a race-adjusted cut-point for IDA. However, this race-adjusted cut-point was recently determined to be unfounded. IDA ranges included hemoglobin ≤11 g/dL for the first trimester, ≤10.5 g/dL for the second trimester, and ≤11 g/dL for the third trimester. IDA ranges with the correction for Black women were hemoglobin ≤10.2 g/dL for the first trimester, ≤9.7 g/dL for the second trimester, and ≤10.2 g/dL for the third trimester.
Measured: Assessed at baseline (i.e., 15-20 weeks gestation) through delivery; mean change from baseline to delivery is reported.
Infant Hemoglobin
Mean infant serum hemoglobin (g/dl) from cord blood at delivery.
Measured: delivery
Infant Hematocrit
Mean infant serum hematocrit (%) from cord blood at delivery.
Measured: delivery
Infant Iron
Mean infant serum iron (µg/dL) from cord blood at delivery.
Measured: delivery
Infant Total Iron Binding Capacity
Mean infant total iron binding capacity (µmol/L) from cord blood at delivery.
Measured: delivery
Infant Serum Ferritin
Mean infant serum ferritin (ng/mL) from cord blood at delivery.
Measured: delivery
Infant Transferrin Saturation
Mean infant transferrin saturation (%) from cord blood at delivery.
Measured: delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start19 Nov 2018
- Primary completion21 Jul 2020
- Study completion21 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron-deficiencyStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Mary Dawn Koenig, University of Illinois at Chicago
- Investigators
- Mary Dawn D Koenig, PhD, RN, CNM, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646487
- Sponsor's protocol ID
- 2016-0662
- Other IDs
- 5R34HL155481-03
- Status last verified
- Apr 2023
- First submitted
- 20 Aug 2018
- Last updated
- 7 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
OjiNjideka Hemphill N, Pezley L, Steffen A, Elam G, Kominiarek MA, Odoms-Young A, Kessee N, Hamm A, Tussing-Humphreys L, Koenig MD. Feasibility Study of Lactobacillus Plantarum 299v Probiotic Supplementation in an Urban Academic Facility among Diverse Pregnant Individuals. Nutrients. 2023 Feb 9;15(4):875. doi: 10.3390/nu15040875.
PubMed 36839232
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Pro-Moms" - Mitigating the Effects of Structural Violence on Maternal Iron Status: a Randomized Placebo Controlled Pilot Study of Probiotic Supplementation in At-risk Pregnant Women
- ClinicalTrials.gov ID
- NCT03646487
- Acronym / sponsor ID
- 2016-0662
- Conditions
- Iron-deficiency, Pregnancy, High Risk, Stress, Psychological
- Keywords
- pregnancy, iron status, structural violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 21 Jul 2020 (actual)
- Study completion
- 21 Jul 2020 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Posted 7 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized supplementation feasibility trial is to learn about the feasibility and preliminary efficacy of the probiotic, lactobacillus plantarum 299v (Lp299v), in pregnant individuals at-risk for iron deficiency anemia.
The main questions it aims to answer are:
- Is daily oral Lp299v a feasible and tolerable intervention for pregnant individuals to uptake?
- Does daily oral Lp299v in pregnancy impact maternal and neonatal cord hematological and iron status parameters?
Participants will be randomly assigned to one of two treatment groups: daily intake or probiotic Lp299v + prenatal vitamin with iron or placebo + prenatal vitamin with iron from 15-20 weeks of gestation through delivery.
Researchers will compare the two treatment groups to see if there is a difference in the feasibility of the intervention and the preliminary efficacy on maternal and neonatal cord hematological and iron status parameters.
Detailed description
The most prevalent micronutrient deficiency in the United States (U.S.) is iron; a large majority of cases of iron deficiency (ID) and iron deficiency anemia (IDA) occur among pregnant women. During pregnancy, maternal iron stores are used for the growing fetus, maternal red blood cell (RBC) expansion, and placental growth and development, thus increasing the risk for ID and IDA. Across all trimesters of pregnancy in the U.S., it is estimated that 18% of individuals have ID and 5% have IDA, and within the third trimester, the prevalence of ID exceeds 27%. Prevalence of IDA is even greater among those who identify as Black or low-income. Maternal ID and IDA are associated with increased risk of preterm birth, low infant birth weight, maternal and fetal mortality, and irreversible infant neurocognitive defects. To meet this increasing requirement for iron and to optimize maternal iron nutrition, the Recommended Dietary Allowance for pregnancy is 27 mg/day of iron. However, given the continued high rates of maternal ID and IDA and only modest adherence to daily prenatal vitamins containing iron, alternative approaches to optimizing iron nutrition in pregnancy are needed.
Research has shown that one-time or short-term dosing of the probiotic Lactobacillus plantarum 299v (Lp299v) enhances iron absorption in non-pregnant populations. However, few studies have examined the effect of long-term supplementation on body iron stores. While probiotics are considered safe to consume in pregnancy, only one Lp299v supplementation trial has been conducted during the gestational period to evaluate its effects on maternal iron stores and risk of IDA. This study, among iron-sufficient pregnant Swedish women, showed a significantly lower decline in iron stores and a significantly lower prevalence of IDA in the third trimester among those randomized to Lp299v compared to standard care control.
These results offer potential positive effects for the role of Lp299v in maintaining maternal iron status among those starting pregnancy with sufficient iron stores and who receive care in a decentralized publicly funded healthcare system. However, no studies have evaluated the effect of Lp299v on maternal iron status among individuals at risk for IDA in pregnancy in the U.S., nor have studies extended findings to neonatal iron status. Moreover, it is unknown if positive feasibility and preliminary efficacy would persist in a U.S.-based health care setting with racially, ethnically, and socioeconomically diverse pregnant individuals. Therefore, the objectives of this study were as follows. First and foremost, we examined the feasibility of daily oral Lp299v maternal supplementation taken from the early second trimester through birth. Second, we explored the preliminary efficacy of Lp299v intake on maternal (at-risk for IDA defined as hemoglobin (Hb) between 10.0-12.0 g/dL) and neonatal cord hematological and iron status parameters compared to controls in an urban U.S. academic medical center with a racially, ethnically, and socioeconomically diverse patient population.
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 |
|---|---|---|
| Probiotic LP299v | Experimental | Dietary Supplement: Probiotic LP299v 10x10 colony forming units in capsule formWomen will receive 1 LP299v (10x10 colony forming units) in capsule form and 1 standard prenatal supplement in tablet form daily beginning at 15 weeks gestation through delivery. |
| Placebo | Placebo comparator | Other: Placebo in capsule formWomen will receive 1 placebo in capsule form and 1 standard prenatal supplement in table form daily beginning at 15 weeks gestation through delivery. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- a 1st trimester hemoglobin (Hb) of 10.0 - 11.9 g/dl demonstrating ID or risk for prenatal ID
- singleton
- naturally conceived pregnancy
- < 20 weeks gestation
- 18 - 45 years of age
Key exclusion criteria (11 listed)
- oral antibiotic use within the past 2 months
- autoimmune disease
- infection
- receiving steroid treatment
- bariatric surgery
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 |
|---|---|---|
| Probiotic LP299v 10x10 colony forming units in capsule formDaily lactobacillus plantarum (LP299v) 10x10 colony forming units in capsule form | Dietary supplement | Probiotic LP299v |
| Placebo in capsule formDaily placebo in capsule form | Other | Placebo |
Primary outcome
Mean Adherence to the Supplement Regimen
Time frame: 15 weeks gestation through delivery, an average of 25 weeks
Mean adherence to the supplement regimen using Pillsy smart bottles and standard pill counts.
15 secondary outcomes
Number of Treatment-emergent Adverse Events Related to GI Symptoms
Time frame: 15 weeks gestation through delivery, an average of 25 weeks
Maternal Hemoglobin
Time frame: Assessed at baseline (i.e., 15-20 weeks gestation) through delivery; mean change from baseline to delivery is reported.
Maternal Hematocrit
Time frame: Assessed at baseline (i.e., 15-20 weeks gestation) through delivery; mean change from baseline to delivery is reported.
Maternal Iron
Time frame: Assessed at baseline (i.e., 15-20 weeks gestation) through delivery; mean change from baseline to delivery is reported.
Maternal Total Iron Binding Capacity
Time frame: Assessed at baseline (i.e., 15-20 weeks gestation) through delivery; mean change from baseline to delivery is reported.
Maternal Serum Ferritin
Time frame: Assessed at baseline (i.e., 15-20 weeks gestation) through delivery; mean change from baseline to delivery is reported.
Maternal Transferrin Saturation
Time frame: Assessed at baseline (i.e., 15-20 weeks gestation) through delivery; mean change from baseline to delivery is reported.
Maternal High-sensitivity C-reactive Protein (Hs-CRP)
Time frame: Assessed at baseline (i.e., 15-20 weeks gestation) through delivery; mean change from baseline to delivery is reported.
Maternal Iron Deficiency Anemia
Time frame: Assessed at baseline (i.e., 15-20 weeks gestation) through delivery; mean change from baseline to delivery is reported.
Infant Hemoglobin
Time frame: delivery
Infant Hematocrit
Time frame: delivery
Infant Iron
Time frame: delivery
Infant Total Iron Binding Capacity
Time frame: delivery
Infant Serum Ferritin
Time frame: delivery
Infant Transferrin Saturation
Time frame: delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36839232OjiNjideka Hemphill N, Pezley L, Steffen A, Elam G, Kominiarek MA, Odoms-Young A, Kessee N, Hamm A, Tussing-Humphreys L, Koenig MD. Feasibility Study of Lactobacillus Plantarum 299v Probiotic Supplementation in an Urban Academic Facility among Diverse Pregnant Individuals. Nutrients. 2023 Feb 9;15(4):875. doi: 10.3390/nu15040875.
- Feasibility Study of Lactobacillus Plantarum 299v Probiotic Supplementation in an Urban Academic Facility among Diverse Pregnant IndividualsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Iron-deficiency
Active, not recruiting
A Study to Evaluate the Effects of a Beef Liver Supplement on Energy, Mood, and Mental Clarity
Fatigue, Low Mood
Active, not recruitingObservational study
Heme and Non-heme Iron Intakes, Gut Microbiota, and Influence on Host Iron Absorption
Anemia, Iron Deficiency, Iron Overload
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
Active, not recruitingObservational study
Ethnic Differences in Iron Absorption (FeGenes)
Anemia, Iron Deficiency, Iron Overload
Recruiting
Safety and Efficacy of Iron Prophylaxis With on Iron Homeostasis in Healthy Pregnant Women
Iron Deficiency Anemia in Pregnancy, Iron Deficiency in Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Dawn D Koenig, PhD, RN, CNM principal investigator
University of Illinois at Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic LP299v 10x10 colony forming units in capsule form in people with Iron-deficiency and Pregnancy, High Risk, 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 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 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 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Adherence to the Supplement Regimen (time frame: 15 weeks gestation through delivery, an average of 25 weeks). 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 NCT03646487, which also lists 1 linked publication.
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 7 Apr 2023.