HIVMIGH-T MONCT05282485
Mitigating Infectious Morbidity and Growth Deficits in HIV Exposed Uninfected infanTs With Human Milk Oligosaccharides
A study testing Synbiotic and Maltodextrin in people with HIV and Infant Morbidity, run by Columbia University at 1 site in South Africa.
Trial summary
Primary Objective: To evaluate the effects of synbiotics on infectious morbidity and growth while it is in place from 4 to 24 weeks of age. To evaluate the effects of synbiotics on infectious morbidity and growth from 4 to 48 weeks of age. Read more about this study
- Who is it for?
- Ages 3 to 6 weeksHealthy volunteers can take part
- Conditions the study is for
- HIV, Infant Morbidity, Breast Feeding
- What is being tested?
- Synbiotic and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteSouth Africa
- Study dates
- 2 Jun 2022to 25 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Greater than 18 years of age
- For HIV-exposed uninfected children (CHEU): Mothers living with HIV documented based on medical record and with viral suppression (i.e., <400 copies/mL viral load) documented at delivery
- For HIV-unexposed uninfected children (CHUU): Mothers without HIV (document HIV-negative test result at delivery or screening)
- Women who initiated breastfeeding of their infant including:
Show all 16Show fewer
- Women who currently exclusively breastfeed their infants, or
- Women who breastfed their infants for a period but are no longer breastfeeding, or
- Women who are currently breastfeeding their infants in addition to feeding them formula milk or solids
- For women with HIV: Those currently on first-line standard of care antiretroviral therapy that was initiated a minimum of 12 weeks prior to delivery of the infant included in this study
- Participant has a cell phone that can be used for calls and messages
- Agreement to adhere to Lifestyle Considerations throughout study duration
- 3-6 weeks of age
- Delivered from a singleton pregnancy
- For children of mothers with HIV: At least one HIV diagnostic nucleic acid amplification test prior to enrollment which is negative and no positive test
- Child is well enough to have established full breastfeeding by the time of enrollment
Who cannot join
- Severe maternal or infant illness (e.g., maternal: tuberculosis, major psychiatric or neurological conditions; infant: any congenitally-acquired infections, major congenital anomalies)
- Use of immunomodulatory or immunosuppressive drugs in either mother or child prior to enrollment in the study
- For mothers with HIV: Mothers who are not currently receiving antiretroviral therapy or who are on regimens other than the currently recommended first-line standard of care in South Africa i.e., first-line dolutegravir- or efavirenz-based regimens.
- Children infected with HIV
- Mother or infant currently taking probiotics, prebiotics, or fiber supplements; or on any nutritional supplements (e.g., FM85) that impact the outcomes of interest
- Mother or infant currently taking antibiotics for more than 14 days, excluding preventative therapies
- Known allergic reactions to components of the treatment or placebo
- Any condition that, in the opinion of the study staff, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the aims of the study.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Worcester Campus of Stellenbosch University (SU)
Stellenbosch, Western Cape, 7599
About this study
Primary Objective:
- To evaluate the effects of synbiotics on infectious morbidity and growth while it is in place from 4 to 24 weeks of age.
- To evaluate the effects of synbiotics on infectious morbidity and growth from 4 to 48 weeks of age.
Read more
Secondary Objectives:
- To evaluate the effects of synbiotics on growth from 4 to 72 weeks of age.
- To evaluate the effects of synbiotics on infant neurodevelopment at 48 and 72 weeks of age.
- To evaluate the effects of synbiotics on biological measurements while it is in place from 4 to 24 weeks of age.
- To evaluate the effects of synbiotics on biological measurements from 4 to 48 weeks of age.
- To evaluate the effects of synbiotics on gut microbiome and fecal short chain fatty acids from 4 to 72 weeks of age.
- To investigate feasibility, acceptance, tolerability, and behavioral adherence with the intervention.
- To investigate whether the synbiotics reduces infectious morbidity and improves growth in CHEU relative to CHUU.
- To investigate whether infant gut microbiota composition, maturity and function, and markers of inflammation and HMOs at baseline and over time are associated with morbidity and poor growth in CHEU and CHUU.
Read the detailed description
Children who are HIV-exposed uninfected (CHEU), i.e., children born to mothers with HIV but who do not acquire HIV infection, have a higher risk of mortality, infectious morbidity, and growth deficits than children who are HIV-unexposed uninfected (CHUU), i.e., children whose mothers do not have HIV. Prior research has focused on breastfeeding and has pointed to changes in human milk oligosaccharides (HMOs) associated with maternal HIV infection that appear to influence the infant microbiome and thereby lead to these adverse outcomes. A randomized trial of an intervention which combines HMOs and probiotics in breastfed CHEU will be conducted in South Africa to evaluate whether this intervention has the potential to reduce excess infectious morbidity and growth faltering risks observed in CHEU. CHEU will be randomized 1:1 to either a) intervention (synbiotic: 2'-FL HMO + B. infantis probiotic) or b) placebo (Maltodextrin). The study intervention or placebo will be given from 4-24 weeks of age (total 20 weeks), followed by another 48 weeks of observation off study treatment. Both arms will be followed to 72 weeks of age for assessment of infant outcomes.
- Conditions
- HIV, Infant Morbidity, Breast Feeding
- Being tested
- Synbiotic, Maltodextrin
- Keywords
- HIV, Infant Morbidity, Infant Growth, Breastmilk, Probiotic, Synbiotic, HIV-exposed Uninfected Infants, B. infantis, Human Milk Oligosaccharides, 2'-Fucosyllactose, Infant neurodevelopment
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynbioticDietary supplement
Synbiotic (2'-FL HMO + B. infantis probiotics)
MaltodextrinDietary supplement
Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Synbiotic Group | Experimental | A synbiotic combining 2'-Fucosyllactose (2'-FL) human milk oligosaccharides (HMO) with B.infantis (probiotic) will be administered to infants from 4 to 24 weeks of age. Receives: Dietary Supplement: Synbiotic |
| Placebo Group | Placebo comparator | Maltodextrin will be administered to infants from 4 to 24 weeks of age. Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of infants with infectious morbidity from 4-24 weeks
Infectious morbidity data related to infectious respiratory or gastrointestinal morbidity will be compared between the two arms
Measured: 4-24 weeks of age
Infant length for age Z scores (LAZ) from 4-24 weeks
Infant anthropometry will be recorded at each visit to calculate infant length for age Z scores (LAZ) will be compared between the two arms
Measured: 4-24 weeks of age
Proportion of infants with infectious morbidity from 4-48 weeks
Infectious morbidity data related to infectious respiratory or gastrointestinal morbidity will be compared between the two arms
Measured: 4-48 weeks of age
Infant length for age Z scores (LAZ) from 4-48 weeks
Infant anthropometry will be recorded at each visit to calculate infant length for age Z scores (LAZ) will be compared between the two arms
Measured: 4-48 weeks of age
Secondary outcomes (14)
Infant weight for age (WAZ) and weight for length (WLZ) Z scores from 4-24 weeks
Infant anthropometry will be recorded at each visit to calculate infant weight for age (WAZ) and weight for length (WLZ) Z scores and will be compared between the two arms
Measured: 4-24 weeks of age
Infant weight for age (WAZ) and weight for length (WLZ) Z scores from 4-48 weeks
Infant anthropometry will be recorded at each visit to calculate infant weight for age (WAZ) and weight for length (WLZ) Z scores and will be compared between the two arms
Measured: 4-48 weeks of age
Infant length for age (LAZ), weight for age (WAZ) and weight for length (WLZ) Z scores from 4-72 weeks
Infant anthropometry will be recorded at each visit to calculate infant length for age (LAZ), weight for age (WAZ) and weight for length (WLZ) Z scores and will be compared between the two arms
Measured: 4-72 weeks of age
Infant microbiota-for-age Z scores (MAZ)
Infant microbiota-for-age Z scores (MAZ), a measure of infant microbiome maturity, will be compared between the two arms
Measured: 4-72 weeks of age
Infant microbiota diversity
Microbiota diversity of taxa will be compared between the two arms
Measured: 4-72 weeks of age
Infant microbiota relative abundance
Microbiota relative abundance of taxa will be compared between the two arms
Measured: 4-72 weeks of age
Infant fecal short-chain fatty acid levels
Short-chain fatty acid (SCFA) levels in stool samples from infants will be compared between the two arms
Measured: 4-72 weeks of age
Infant plasma metabolite levels
Unbiased metabolomics will be used to investigate whether metabolite levels and major metabolic pathways are different between the two arms
Measured: 4-24 weeks of age
Infant plasma inflammatory markers and growth hormone levels
Levels of protein inflammatory markers and growth hormones will be measured using immunoassays and will be compared between the two arms
Measured: 4-48 weeks of age
Infant plasma HMO levels
Infant HMO levels will be measured and compared between the two arms
Measured: 4-24 weeks of age
Proportion of infants with Adverse Events (AEs)/Serious Adverse Event (SAEs)
Proportion of AE/SAEs will be recorded and compared between the two arms to assess the safety of the intervention
Measured: Through 24 weeks of age
Proportion of infants with tolerability symptoms
Digestive tolerability will be assessed and compared between the two arms to assess the safety of the intervention
Measured: Through 8 weeks of age
Proportion of infants with severe infectious morbidity
Severe infectious morbidity (i.e., those requiring hospitalizations) data related to infectious respiratory or gastrointestinal morbidity will be compared between the two arms
Measured: 4-48 weeks of age
Infant neurodevelopment milestones
A comprehensive neurodevelopment assessment, i.e., Griffiths III scale, will be conducted on infants at weeks 48 and 72 and the proportion passing each milestone will be compared between the two arms
Measured: 48-72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start2 Jun 2022
- Primary completion25 Jun 2026
- Study completion25 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Model description
- This study will recruit 144 women living with HIV and their HIV-exposed uninfected children (72 will receive the interventional product and 72 will receive the placebo). All of the women in the study will have breastfed or are currently breastfeeding their children.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Stellenbosch, University of California, Los Angeles, University of California, San Diego, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Rupak Shivakoti, Columbia University
- Investigators
- Rupak Shivakoti, PhD, Principal investigator, Columbia University Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282485
- Sponsor's protocol ID
- AAAT8393
- Other IDs
- R01HD105492
- Acronym
- MIGH-T MO
- Status last verified
- Jun 2026
- First submitted
- 10 Feb 2022
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shivakoti R, Laughton B, Shafiq M, Schoeman E, Glashoff RH, Barnabas S, Fry S, Leu CS, Wang S, Bode L, Aldrovandi G, Kuhn L, Slogrove AL. Feasibility Study of a Powder-Based Supplement Intervention for a future Synbiotic Trial in Breastfed Children from South Africa. Res Sq [Preprint]. 2023 May 15:rs.3.rs-2842773. doi: 10.21203/rs.3.rs-2842773/v1.
PubMed 37293067Shivakoti R, Slogrove AL, Laughton B, Shafiq M, Schoeman E, Glashoff RH, Leu CS, Wang S, Bode L, Aldrovandi G, Kuhn L. Mitigating Infectious morbidity and Growth deficits in HIV-exposed uninfected infanTs with human Milk Oligosaccharide (MIGH-T MO): a randomised trial protocol. BMJ Open. 2022 Dec 30;12(12):e069116. doi: 10.1136/bmjopen-2022-069116.
PubMed 36585139
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigating Infectious Morbidity and Growth Deficits in HIV Exposed Uninfected infanTs With Human Milk Oligosaccharides
- ClinicalTrials.gov ID
- NCT05282485
- Acronym / sponsor ID
- MIGH-T MO / AAAT8393
- Conditions
- HIV, Infant Morbidity, Breast Feeding
- Keywords
- HIV, Infant Morbidity, Infant Growth, Breastmilk, Probiotic, Synbiotic, HIV-exposed Uninfected Infants, B. infantis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- University of Stellenbosch, University of California, Los Angeles, University of California, San Diego, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 25 Jun 2026 (actual)
- Study completion
- 25 Jun 2026 (actual)
- First posted
- 16 Mar 2022 (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.
Primary Objective:
- To evaluate the effects of synbiotics on infectious morbidity and growth while it is in place from 4 to 24 weeks of age.
- To evaluate the effects of synbiotics on infectious morbidity and growth from 4 to 48 weeks of age.
Secondary Objectives:
- To evaluate the effects of synbiotics on growth from 4 to 72 weeks of age.
- To evaluate the effects of synbiotics on infant neurodevelopment at 48 and 72 weeks of age.
- To evaluate the effects of synbiotics on biological measurements while it is in place from 4 to 24 weeks of age.
- To evaluate the effects of synbiotics on biological measurements from 4 to 48 weeks of age.
- To evaluate the effects of synbiotics on gut microbiome and fecal short chain fatty acids from 4 to 72 weeks of age.
- To investigate feasibility, acceptance, tolerability, and behavioral adherence with the intervention.
- To investigate whether the synbiotics reduces infectious morbidity and improves growth in CHEU relative to CHUU.
- To investigate whether infant gut microbiota composition, maturity and function, and markers of inflammation and HMOs at baseline and over time are associated with morbidity and poor growth in CHEU and CHUU.
Detailed description
Children who are HIV-exposed uninfected (CHEU), i.e., children born to mothers with HIV but who do not acquire HIV infection, have a higher risk of mortality, infectious morbidity, and growth deficits than children who are HIV-unexposed uninfected (CHUU), i.e., children whose mothers do not have HIV. Prior research has focused on breastfeeding and has pointed to changes in human milk oligosaccharides (HMOs) associated with maternal HIV infection that appear to influence the infant microbiome and thereby lead to these adverse outcomes. A randomized trial of an intervention which combines HMOs and probiotics in breastfed CHEU will be conducted in South Africa to evaluate whether this intervention has the potential to reduce excess infectious morbidity and growth faltering risks observed in CHEU. CHEU will be randomized 1:1 to either a) intervention (synbiotic: 2'-FL HMO + B. infantis probiotic) or b) placebo (Maltodextrin). The study intervention or placebo will be given from 4-24 weeks of age (total 20 weeks), followed by another 48 weeks of observation off study treatment. Both arms will be followed to 72 weeks of age for assessment of infant outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study will recruit 144 women living with HIV and their HIV-exposed uninfected children (72 will receive the interventional product and 72 will receive the placebo). All of the women in the study will have breastfed or are currently breastfeeding their children.
| Arm | Type | Receives |
|---|---|---|
| Synbiotic Group | Experimental | Dietary Supplement: SynbioticA synbiotic combining 2'-Fucosyllactose (2'-FL) human milk oligosaccharides (HMO) with B.infantis (probiotic) will be administered to infants from 4 to 24 weeks of age. |
| Placebo Group | Placebo comparator | Dietary Supplement: MaltodextrinMaltodextrin will be administered to infants from 4 to 24 weeks of age. |
Who may qualify
- Ages
- 3 to 6 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (16 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Greater than 18 years of age
- For HIV-exposed uninfected children (CHEU): Mothers living with HIV documented based on medical record and with viral suppression (i.e., <400 copies/mL viral load) documented at delivery
- For HIV-unexposed uninfected children (CHUU): Mothers without HIV (document HIV-negative test result at delivery or screening)
Key exclusion criteria (8 listed)
- Severe maternal or infant illness (e.g., maternal: tuberculosis, major psychiatric or neurological conditions; infant: any congenitally-acquired infections, major congenital anomalies)
- Use of immunomodulatory or immunosuppressive drugs in either mother or child prior to enrollment in the study
- For mothers with HIV: Mothers who are not currently receiving antiretroviral therapy or who are on regimens other than the currently recommended first-line standard of care in South Africa i.e., first-line dolutegravir- or efavirenz-based regimens.
- Children infected with HIV
- Mother or infant currently taking probiotics, prebiotics, or fiber supplements; or on any nutritional supplements (e.g., FM85) that impact the outcomes of interest
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 |
|---|---|---|
| SynbioticSynbiotic (2'-FL HMO + B. infantis probiotics) | Dietary supplement | Synbiotic Group |
| MaltodextrinMaltodextrin | Dietary supplement | Placebo Group |
Primary outcome
Proportion of infants with infectious morbidity from 4-24 weeks
Time frame: 4-24 weeks of age
Infectious morbidity data related to infectious respiratory or gastrointestinal morbidity will be compared between the two arms
Infant length for age Z scores (LAZ) from 4-24 weeks
Time frame: 4-24 weeks of age
Infant anthropometry will be recorded at each visit to calculate infant length for age Z scores (LAZ) will be compared between the two arms
Proportion of infants with infectious morbidity from 4-48 weeks
Time frame: 4-48 weeks of age
Infectious morbidity data related to infectious respiratory or gastrointestinal morbidity will be compared between the two arms
Infant length for age Z scores (LAZ) from 4-48 weeks
Time frame: 4-48 weeks of age
Infant anthropometry will be recorded at each visit to calculate infant length for age Z scores (LAZ) will be compared between the two arms
14 secondary outcomes
Infant weight for age (WAZ) and weight for length (WLZ) Z scores from 4-24 weeks
Time frame: 4-24 weeks of age
Infant weight for age (WAZ) and weight for length (WLZ) Z scores from 4-48 weeks
Time frame: 4-48 weeks of age
Infant length for age (LAZ), weight for age (WAZ) and weight for length (WLZ) Z scores from 4-72 weeks
Time frame: 4-72 weeks of age
Infant microbiota-for-age Z scores (MAZ)
Time frame: 4-72 weeks of age
Infant microbiota diversity
Time frame: 4-72 weeks of age
Infant microbiota relative abundance
Time frame: 4-72 weeks of age
Infant fecal short-chain fatty acid levels
Time frame: 4-72 weeks of age
Infant plasma metabolite levels
Time frame: 4-24 weeks of age
Infant plasma inflammatory markers and growth hormone levels
Time frame: 4-48 weeks of age
Infant plasma HMO levels
Time frame: 4-24 weeks of age
Proportion of infants with Adverse Events (AEs)/Serious Adverse Event (SAEs)
Time frame: Through 24 weeks of age
Proportion of infants with tolerability symptoms
Time frame: Through 8 weeks of age
Proportion of infants with severe infectious morbidity
Time frame: 4-48 weeks of age
Infant neurodevelopment milestones
Time frame: 48-72 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Derived from this study: PubMed 37293067Shivakoti R, Laughton B, Shafiq M, Schoeman E, Glashoff RH, Barnabas S, Fry S, Leu CS, Wang S, Bode L, Aldrovandi G, Kuhn L, Slogrove AL. Feasibility Study of a Powder-Based Supplement Intervention for a future Synbiotic Trial in Breastfed Children from South Africa. Res Sq [Preprint]. 2023 May 15:rs.3.rs-2842773. doi: 10.21203/rs.3.rs-2842773/v1.
- Derived from this study: PubMed 36585139Shivakoti R, Slogrove AL, Laughton B, Shafiq M, Schoeman E, Glashoff RH, Leu CS, Wang S, Bode L, Aldrovandi G, Kuhn L. Mitigating Infectious morbidity and Growth deficits in HIV-exposed uninfected infanTs with human Milk Oligosaccharide (MIGH-T MO): a randomised trial protocol. BMJ Open. 2022 Dec 30;12(12):e069116. doi: 10.1136/bmjopen-2022-069116.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Rupak Shivakoti, PhD principal investigator
Columbia University Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synbiotic and Maltodextrin in people with HIV and Infant Morbidity, run by Columbia University at 1 site in South Africa.
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 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 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 South Africa. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of infants with infectious morbidity from 4-24 weeks (time frame: 4-24 weeks of age). The study lists 4 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 NCT05282485, which also lists 2 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 1 Jul 2026.