HealthyBMONCT01814540
Bovine Milk Oligosaccharide Study
A study testing Bovine Milk Oligosaccharide in people with Healthy, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to elucidate tolerability and effectiveness in consumption of the complex indigestible sugars from dairy products called bovine milk oligosaccharides (BMO) to enrich intestinal microflora toward beneficial populations. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Bovine Milk Oligosaccharide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2012to 22 Jan 2021
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women aged 18-40 years old
- BMI 18-25
- Born by vaginal birth (not C-section)
- Breastfed for a minimum of 2 months after birth
Who cannot join
- Individuals who regularly consume high fiber cereals or fiber supplements
- Individuals who frequently consume yogurt (eligible if willing to refrain consumption during the study period)
- Individuals who are lactose intolerant and/or allergic to dairy or wheat
- Individuals who use tobacco products
- Individuals who are pregnant or lactating
- Individuals with a known presence of gastrointestinal/malabsorption disorders or autoimmune disease
- Individuals taking prescription or over-the-counter medications that include pre/probiotics, corticosteroids, anti-obesity agents, laxatives, and lipid- altering medications
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Davis, California, 95616
About this study
Official title: Pilot Study: Tolerability of Feeding Different Doses of Bovine Milk Oligosaccharides for Modifying Gastrointestinal Function in Healthy Individuals
The purpose of this study is to elucidate tolerability and effectiveness in consumption of the complex indigestible sugars from dairy products called bovine milk oligosaccharides (BMO) to enrich intestinal microflora toward beneficial populations.
Read the detailed description
This is a single-blind crossover study designed to determine if BMO at two different doses selectively enrich beneficial bacteria in the human gut and will be tolerated in healthy participants compared with a placebo control supplement. Each participant will consume two sachets of supplement for eleven days, separated by a two-week washout before starting the second and third arms. To determine the effect of dose, the placebo-control supplement will be administered in the first arm, followed by the low and high dose. Participants will collect stool and first morning urine and study personnel collected blood from each participant at baseline (day 0) and at the end (Day 11) of each study arm for all three arms.
- Conditions
- Healthy
- Being tested
- Bovine Milk Oligosaccharide, Placebo Glucose Polymer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bovine Milk OligosaccharideDietary supplement
The BMO powder will be isolated from whey streams by Hilmar Ingredients (Hilmar, California 95324). Hilmar Ingredients employs the same membrane filtration, and centrifugation processes used to purify whey protein in their commercial practice to extract and purify BMO from whey permeate. Furthermore, the same sterilization processes used on the equipment to purify whey products will be used to purify BMO. This method uses a novel high-throughput food-grade isolation protocol that leads to purification of specific BMOs with bifidogenic activity as prebiotic oligosaccharides that mimic the activities observed for Human Milk Oligosaccharides (HMO). This strategy of developing methods for their large scale fractionation allows us to obtain a final product that mimics the naturally beneficial oligosaccharides present in human milk.
Placebo Glucose PolymerDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo Control, Glucose polymer | Placebo comparator | Treatment 1: Polycose Glucose Polymer Module powder (Abbott Nutrition, Abbott Park, Illinois 60064), fed as 25% of each individual's daily fiber intake based on calculated energy expenditure (14 grams of fiber for every 1000 kcal consumed) for eleven consecutive days. Receives: Dietary Supplement: Placebo Glucose Polymer |
| Treatment 2: Low-Dose BMO | Experimental | Treatment 2: Bovine Milk Oligosaccharide (BMO) powder (Hilmar Ingredients, Hilmar, California 95324) Dosage: 25% of individual daily fiber intake, split into two daily servings Frequency: Two servings per day (for total of 25% dosage per day) Duration: 11 days, followed by a 2-week wash-out period
Fiber intake was 25% of each individual's daily fiber intake based on calculated energy expenditure (14 grams of fiber for every 1000 kcal consumed) for eleven consecutive days. Receives: Dietary Supplement: Bovine Milk Oligosaccharide |
| Treatment 3: High-Dose BMO | Experimental | Treatment 3: Bovine Milk Oligosaccharide (BMO) powder (Hilmar Ingredients, Hilmar, California 95324) Dosage: 35% of individual daily fiber intake, split into two daily servings Frequency: Two servings per day (for total of 25% dosage per day) Duration: 11 days, followed by a 2-week wash-out period
Fiber intake was 35% of each individual's daily fiber intake based on calculated energy expenditure (14 grams of fiber for every 1000 kcal consumed) for eleven consecutive days. Receives: Dietary Supplement: Bovine Milk Oligosaccharide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiota
Gut microbiota will be analyzed for 16s rRNA by next generation sequencing, terminal restriction fragment length polymorphism, and quantitative polymerase chain reaction.
Measured: Change from baseline to day 11
Secondary outcomes (8)
Urinary Metabolites
First morning urine samples will be analyzed by nuclear magnetic resonance spectroscopy.
Measured: Days 0, 4, 11
Plasma Lipid Profile
Fasting plasma lipid profile (total triglycerides, total cholesterol, LDL-cholesterol, HDL-cholesterol) will be analyzed by enzymatic analysis by UC Davis Pathology Lab.
Measured: Day 0 and Day 11
Plasma Glucose
Fasting plasma glucose will be measured by enzyme analysis by UC Davis Pathology Lab.
Measured: Day 0 and Day 11
Dietary Macronutrient Intake
Participants will fill out three-day diet records for two weekdays and one weekend before starting each dietary supplemental arm in order to determine if intake of BMO vs. placebo control influences habitual dietary intake.
Measured: Day 0
Gut Tolerability
Participants will fill out a standardized gut tolerability questionnaire (Pedersen et al., 1997) rating their symptoms of gut and stomach discomfort on a 0-10 discretized visual analog scale daily seven days before starting each arm and on five different occasions on Days 0-10 during each study arm.
Measured: Days Minus 7 and Days 0-10
Stool Consistency
Participants will fill out the Bristol Stool Scale when they have bowel movements seven days before starting each study arm and daily during each study arm. The discretized visual analog scale 1-7 describes hardness to softness of stool.
Measured: Minus Day 7 and Days 0-10
Fecal BMO
Measurement of BMOs in feces
Measured: Days 0, 4 and 11
Fecal Metatranscriptome
Measurement of fecal metatranscriptome
Measured: Days 0 and 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2013 (estimated)
- Study start1 Aug 2012
- Primary completion16 Nov 2012
- Study completion22 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Research Institute
- Responsible party
- Sponsor
- Investigators
- Daniela Barile, PhD, Principal investigator, University of California, DavisJennifer Smilowitz, PhD, Principal investigator, University of California, DavisJ. Bruce German, PhD, Principal investigator, University of California, DavisCarolyn Slupsky, PhD, Principal investigator, University of California, DavisAngela M Zivkovic, PhD, Principal investigator, University of California, DavisDavid A Mills, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01814540
- Sponsor's protocol ID
- 264294
- Acronym
- BMO
- Status last verified
- Sep 2022
- First submitted
- 13 Mar 2013
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Pedersen A, Sandstrom B, Van Amelsvoort JM. The effect of ingestion of inulin on blood lipids and gastrointestinal symptoms in healthy females. Br J Nutr. 1997 Aug;78(2):215-22. doi: 10.1079/bjn19970141.
PubMed 9301412Tao N, DePeters EJ, Freeman S, German JB, Grimm R, Lebrilla CB. Bovine milk glycome. J Dairy Sci. 2008 Oct;91(10):3768-78. doi: 10.3168/jds.2008-1305.
PubMed 18832198Tao N, DePeters EJ, German JB, Grimm R, Lebrilla CB. Variations in bovine milk oligosaccharides during early and middle lactation stages analyzed by high-performance liquid chromatography-chip/mass spectrometry. J Dairy Sci. 2009 Jul;92(7):2991-3001. doi: 10.3168/jds.2008-1642.
PubMed 19528576Barile D, Tao N, Lebrilla CB, Coisson JD, Arlorio M, German JB. Permeate from cheese whey ultrafiltration is a source of milk oligosaccharides. Int Dairy J. 2009 Sep 1;19(9):524-530. doi: 10.1016/j.idairyj.2009.03.008.
PubMed 20161544Barile D, Marotta M, Chu C, Mehra R, Grimm R, Lebrilla CB, German JB. Neutral and acidic oligosaccharides in Holstein-Friesian colostrum during the first 3 days of lactation measured by high performance liquid chromatography on a microfluidic chip and time-of-flight mass spectrometry. J Dairy Sci. 2010 Sep;93(9):3940-9. doi: 10.3168/jds.2010-3156.
PubMed 20723667Strum JS, Aldredge D, Barile D, Lebrilla CB. Coupling flash liquid chromatography with mass spectrometry for enrichment and isolation of milk oligosaccharides for functional studies. Anal Biochem. 2012 May 15;424(2):87-96. doi: 10.1016/j.ab.2012.02.012. Epub 2012 Feb 25.
PubMed 22370281Sundekilde UK, Barile D, Meyrand M, Poulsen NA, Larsen LB, Lebrilla CB, German JB, Bertram HC. Natural variability in bovine milk oligosaccharides from Danish Jersey and Holstein-Friesian breeds. J Agric Food Chem. 2012 Jun 20;60(24):6188-96. doi: 10.1021/jf300015j. Epub 2012 Jun 6.
PubMed 22632419Zivkovic AM, Barile D. Bovine milk as a source of functional oligosaccharides for improving human health. Adv Nutr. 2011 May;2(3):284-9. doi: 10.3945/an.111.000455. Epub 2011 Apr 30.
PubMed 22332060Garrido D, Barile D, Mills DA. A molecular basis for bifidobacterial enrichment in the infant gastrointestinal tract. Adv Nutr. 2012 May 1;3(3):415S-21S. doi: 10.3945/an.111.001586.
PubMed 22585920Aldredge DL, Geronimo MR, Hua S, Nwosu CC, Lebrilla CB, Barile D. Annotation and structural elucidation of bovine milk oligosaccharides and determination of novel fucosylated structures. Glycobiology. 2013 Jun;23(6):664-76. doi: 10.1093/glycob/cwt007. Epub 2013 Feb 22.
PubMed 23436288Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997 Sep;32(9):920-4. doi: 10.3109/00365529709011203.
PubMed 9299672Smilowitz JT, Lemay DG, Kalanetra KM, Chin EL, Zivkovic AM, Breck MA, German JB, Mills DA, Slupsky C, Barile D. Tolerability and safety of the intake of bovine milk oligosaccharides extracted from cheese whey in healthy human adults. J Nutr Sci. 2017 Feb 20;6:e6. doi: 10.1017/jns.2017.2. eCollection 2017.
PubMed 28620481
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Tolerability of Feeding Different Doses of Bovine Milk Oligosaccharides for Modifying Gastrointestinal Function in Healthy Individuals
- ClinicalTrials.gov ID
- NCT01814540
- Acronym / sponsor ID
- BMO / 264294
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Dairy Research Institute
- Study start
- 1 Aug 2012 (actual)
- Primary completion
- 16 Nov 2012 (actual)
- Study completion
- 22 Jan 2021 (actual)
- First posted
- 20 Mar 2013 (estimated)
- 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.
The purpose of this study is to elucidate tolerability and effectiveness in consumption of the complex indigestible sugars from dairy products called bovine milk oligosaccharides (BMO) to enrich intestinal microflora toward beneficial populations.
Detailed description
This is a single-blind crossover study designed to determine if BMO at two different doses selectively enrich beneficial bacteria in the human gut and will be tolerated in healthy participants compared with a placebo control supplement. Each participant will consume two sachets of supplement for eleven days, separated by a two-week washout before starting the second and third arms. To determine the effect of dose, the placebo-control supplement will be administered in the first arm, followed by the low and high dose. Participants will collect stool and first morning urine and study personnel collected blood from each participant at baseline (day 0) and at the end (Day 11) of each study arm for all three arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo Control, Glucose polymer | Placebo comparator | Dietary Supplement: Placebo Glucose PolymerTreatment 1: Polycose Glucose Polymer Module powder (Abbott Nutrition, Abbott Park, Illinois 60064), fed as 25% of each individual's daily fiber intake based on calculated energy expenditure (14 grams of fiber for every 1000 kcal consumed) for eleven consecutive days. |
| Treatment 2: Low-Dose BMO | Experimental | Dietary Supplement: Bovine Milk OligosaccharideTreatment 2: Bovine Milk Oligosaccharide (BMO) powder (Hilmar Ingredients, Hilmar, California 95324) Dosage: 25% of individual daily fiber intake, split into two daily servings Frequency: Two servings per day (for total of 25% dosage per day) Duration: 11 days, followed by a 2-week wash-out period Fiber intake was 25% of each individual's daily fiber intake based on calculated energy expenditure (14 grams of fiber for every 1000 kcal consumed) for eleven consecutive days. |
| Treatment 3: High-Dose BMO | Experimental | Dietary Supplement: Bovine Milk OligosaccharideTreatment 3: Bovine Milk Oligosaccharide (BMO) powder (Hilmar Ingredients, Hilmar, California 95324) Dosage: 35% of individual daily fiber intake, split into two daily servings Frequency: Two servings per day (for total of 25% dosage per day) Duration: 11 days, followed by a 2-week wash-out period Fiber intake was 35% of each individual's daily fiber intake based on calculated energy expenditure (14 grams of fiber for every 1000 kcal consumed) for eleven consecutive days. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy men and women aged 18-40 years old
- BMI 18-25
- Born by vaginal birth (not C-section)
- Breastfed for a minimum of 2 months after birth
Key exclusion criteria (7 listed)
- Individuals who regularly consume high fiber cereals or fiber supplements
- Individuals who frequently consume yogurt (eligible if willing to refrain consumption during the study period)
- Individuals who are lactose intolerant and/or allergic to dairy or wheat
- Individuals who use tobacco products
- Individuals who are pregnant or lactating
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 |
|---|---|---|
| Bovine Milk OligosaccharideThe BMO powder will be isolated from whey streams by Hilmar Ingredients (Hilmar, California 95324). Hilmar Ingredients employs the same membrane filtration, and centrifugation processes used to purify whey protein in their commercial practice to extract and purify BMO from whey permeate. Furthermore, the same sterilization processes used on the equipment to purify whey products will be used to purify BMO. This method uses a novel high-throughput food-grade isolation protocol that leads to purification of specific BMOs with bifidogenic activity as prebiotic oligosaccharides that mimic the activities observed for Human Milk Oligosaccharides (HMO). This strategy of developing methods for their large scale fractionation allows us to obtain a final product that mimics the naturally beneficial oligosaccharides present in human milk. | Dietary supplement | Treatment 2: Low-Dose BMO, Treatment 3: High-Dose BMO |
| Placebo Glucose Polymer | Dietary supplement | Placebo Control, Glucose polymer |
Primary outcome
Gut microbiota
Time frame: Change from baseline to day 11
Gut microbiota will be analyzed for 16s rRNA by next generation sequencing, terminal restriction fragment length polymorphism, and quantitative polymerase chain reaction.
8 secondary outcomes
Urinary Metabolites
Time frame: Days 0, 4, 11
Plasma Lipid Profile
Time frame: Day 0 and Day 11
Plasma Glucose
Time frame: Day 0 and Day 11
Dietary Macronutrient Intake
Time frame: Day 0
Gut Tolerability
Time frame: Days Minus 7 and Days 0-10
Stool Consistency
Time frame: Minus Day 7 and Days 0-10
Fecal BMO
Time frame: Days 0, 4 and 11
Fecal Metatranscriptome
Time frame: Days 0 and 11
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 29 Sep 2022.
- Background: PubMed 9301412Pedersen A, Sandstrom B, Van Amelsvoort JM. The effect of ingestion of inulin on blood lipids and gastrointestinal symptoms in healthy females. Br J Nutr. 1997 Aug;78(2):215-22. doi: 10.1079/bjn19970141.
- Background: PubMed 18832198Tao N, DePeters EJ, Freeman S, German JB, Grimm R, Lebrilla CB. Bovine milk glycome. J Dairy Sci. 2008 Oct;91(10):3768-78. doi: 10.3168/jds.2008-1305.
- Background: PubMed 19528576Tao N, DePeters EJ, German JB, Grimm R, Lebrilla CB. Variations in bovine milk oligosaccharides during early and middle lactation stages analyzed by high-performance liquid chromatography-chip/mass spectrometry. J Dairy Sci. 2009 Jul;92(7):2991-3001. doi: 10.3168/jds.2008-1642.
- Background: PubMed 20161544Barile D, Tao N, Lebrilla CB, Coisson JD, Arlorio M, German JB. Permeate from cheese whey ultrafiltration is a source of milk oligosaccharides. Int Dairy J. 2009 Sep 1;19(9):524-530. doi: 10.1016/j.idairyj.2009.03.008.
- Background: PubMed 20723667Barile D, Marotta M, Chu C, Mehra R, Grimm R, Lebrilla CB, German JB. Neutral and acidic oligosaccharides in Holstein-Friesian colostrum during the first 3 days of lactation measured by high performance liquid chromatography on a microfluidic chip and time-of-flight mass spectrometry. J Dairy Sci. 2010 Sep;93(9):3940-9. doi: 10.3168/jds.2010-3156.
- Background: PubMed 22370281Strum JS, Aldredge D, Barile D, Lebrilla CB. Coupling flash liquid chromatography with mass spectrometry for enrichment and isolation of milk oligosaccharides for functional studies. Anal Biochem. 2012 May 15;424(2):87-96. doi: 10.1016/j.ab.2012.02.012. Epub 2012 Feb 25.
- Background: PubMed 22632419Sundekilde UK, Barile D, Meyrand M, Poulsen NA, Larsen LB, Lebrilla CB, German JB, Bertram HC. Natural variability in bovine milk oligosaccharides from Danish Jersey and Holstein-Friesian breeds. J Agric Food Chem. 2012 Jun 20;60(24):6188-96. doi: 10.1021/jf300015j. Epub 2012 Jun 6.
- Background: PubMed 22332060Zivkovic AM, Barile D. Bovine milk as a source of functional oligosaccharides for improving human health. Adv Nutr. 2011 May;2(3):284-9. doi: 10.3945/an.111.000455. Epub 2011 Apr 30.
- Background: PubMed 22585920Garrido D, Barile D, Mills DA. A molecular basis for bifidobacterial enrichment in the infant gastrointestinal tract. Adv Nutr. 2012 May 1;3(3):415S-21S. doi: 10.3945/an.111.001586.
- Background: PubMed 23436288Aldredge DL, Geronimo MR, Hua S, Nwosu CC, Lebrilla CB, Barile D. Annotation and structural elucidation of bovine milk oligosaccharides and determination of novel fucosylated structures. Glycobiology. 2013 Jun;23(6):664-76. doi: 10.1093/glycob/cwt007. Epub 2013 Feb 22.
- Background: PubMed 9299672Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997 Sep;32(9):920-4. doi: 10.3109/00365529709011203.
- Results publication: PubMed 28620481Smilowitz JT, Lemay DG, Kalanetra KM, Chin EL, Zivkovic AM, Breck MA, German JB, Mills DA, Slupsky C, Barile D. Tolerability and safety of the intake of bovine milk oligosaccharides extracted from cheese whey in healthy human adults. J Nutr Sci. 2017 Feb 20;6:e6. doi: 10.1017/jns.2017.2. eCollection 2017.
- Details for this research project is available through the UC Davis Foods for Health Institute websiteLink provided by the sponsor.
- 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.
Daniela Barile, PhD principal investigator
University of California, Davis
Jennifer Smilowitz, PhD principal investigator
University of California, Davis
J. Bruce German, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bovine Milk Oligosaccharide in people with Healthy, run by University of California, Davis 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 4 inclusion and 7 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 29 Sep 2022. 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?
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?
Gut microbiota (time frame: Change from baseline to day 11). 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 NCT01814540, which also lists 12 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 29 Sep 2022.