Milk IntoleranceNCT03060395
Effects of A2 Milk on Gastrointestinal Function in Non-lactose Milk Intolerance
A study testing A2 milk 100, A2 milk 150 and A2 milk 200 in people with Milk Intolerance, run by University of Reading at 1 site in United Kingdom.
Trial summary
There is increasing evidence that a number of people experience moderate milk intolerance characterised by increased gas production, bloating and abdominal cramp, which can neither be attributed to lactose intolerance, nor to milk protein allergy. Read more about this study
- Who is it for?
- Ages 18 to 56 yearsHealthy volunteers can take part
- Conditions the study is for
- Milk Intolerance
- What is being tested?
- A2 milk 100, A2 milk 150 and A2 milk 200
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2017to 31 Mar 2019
- 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 56 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI: 20-35kg/m2
- Glucose<7mmol/l (not diagnosed with diabetes)
- Total cholesterol<7mmol/l
- Triacylglycerol<4mmol/l
- Normal liver and kidney function
- Regular milk drinker with self-reported intolerance to commercial milk.
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- Suffered from mild to moderate digestive discomfort after milk consumption.
- Have normal blood pressure 120/80 mmHg (BP <160/90 mmHg can be accepted) during quiet respiration.
- Agree not to take any medication, supplements and other dairy products including acidophilus milk
- Be willing to comply with all the requirements and procedures of the study.
- Agree to sign the informed consent form;
- Agree not to enrol in another interventional clinical research study while participating in this study.
- Fully understand the nature, objective, benefit and the potential risks and side effects of the study.
Who cannot join
- Females who are pregnant or planning to be a pregnant and lactating.
- Have known dairy allergy.
- Have stopped drinking milk for the last 6 month.
- Have history of lactose intolerance
- Have history of faecal impaction.
- Received antibiotics in the previous six months
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- Smoker
- Anemia
- Trying to lose weight by following a diet or exercise regimen designed for weight loss, or taking any drug influencing appetite and any drug for weight loss for the last three months.
- Have participated in similar dairy or probiotics-containing product's clinical trials within 3 months before the screening.
- Currently taking medicines for cardiovascular or metabolic disease.
- History of alcohol or drug misuse.
- Have history of or be diagnosed of any of the following diseases that may affect the study results: gastrointestinal disorders, hepatopathy, nephropathy, endocrine disease, blood disorders, respiratory, cardiovascular diseases and known on-going allergy such as asthma.
- Currently suffering from any gastrointestinal disorders or gastrointestinal disease, including irritable bowel syndrome, colitis, ulcerative colitis, celiac disease, irritable bowel syndrome (IBS);
- Had hospitalizations within 3 months before screening; Currently drug frequency user of that may affect the gastrointestinal function or immune system. As judged by investigator.
- Who take medication at least the last 6-month.
- Who do excessive exercise not as part of a weight-loss regime, e.g. athletes.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Food and Nutritional Sciences
Reading, Berkshire, RG6 6AP
About this study
Official title: Effects of A2 Milk on Gastrointestinal Function of Volunteers Affected by Non-lactose Milk Intolerance
There is increasing evidence that a number of people experience moderate milk intolerance characterised by increased gas production, bloating and abdominal cramp, which can neither be attributed to lactose intolerance, nor to milk protein allergy. Milk digestion can lead to the formation of bioactive peptides, one of which derived from a mutated gene variant (A1) coding for milk beta-casein has been associated with increased gastrointestinal inflammation and poor gastrointestinal function. In this study, we hypothesise that consumption of non-mutated A2 milk will improve gastrointestinal symptoms in non-lactose milk intolerant individuals.
Read the detailed description
Non-lactose milk intolerance is a condition that has not been defined clinically yet but the current literature reports existence of subjects who are moderately milk intolerant and whose intolerance can neither be attributed to a defect in lactose intolerance, nor to milk protein allergy. Yet, they experience at least one or two of the following symptoms following milk consumption: gases, bloating, abdominal cramp. It is known that the A1gene variant coding for beta-casein leads to the production of a bioactive peptide with opioid activity named betacasomorphin 7 (BCM7). This peptide has been associated with several metabolic health disorders including diabetes, elevated cardiovascular risk and stimulation of pro-inflammatory signals. Recently, it was reported that non-lactose milk intolerant subjects did not experience such symptoms when consuming milk containing the non-mutated A2 gene variant coding for beta-casein. In this study, we hypothesise that consumption of A2 milk will improve gastrointestinal symptoms in non-lactose milk intolerant individuals. The primary outcome of this study will be the reduction of gastrointestinal inflammation following a course of A2 milk consumption.
- Conditions
- Milk Intolerance
- Being tested
- A2 milk 100, A2 milk 150, A2 milk 200, A2 milk 250, A1/A2 milk 100
- Medical subject headings
- Lactose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A2 milk 100Dietary supplement
Days 1 and 2: 100 mL A2 milk twice a day
A2 milk 150Dietary supplement
Days 3 and 4: 150 mL A2 milk twice a day
A2 milk 200Dietary supplement
Days 5 and 6: 200 mL A2 milk twice a day
A2 milk 250Dietary supplement
Days 7 to 14: 250 mL A2 milk twice a day
A1/A2 milk 100Dietary supplement
Days 1 and 2: 100 mL A1/A2 milk twice a day
A1/A2 milk 150Dietary supplement
Days 3 and 4: 150 mL A1/A2 milk twice a day
A1/A2 milk 200Dietary supplement
Days 5 and 6: 200 mL A1/A2 milk twice a day
A1/A2 milk 250Dietary supplement
Days 7 to14: 250 mL A1/A2 milk twice a day
| Study group | Role | What they receive |
|---|---|---|
| A1/A2 milk | Sham comparator | Commercial conventional A1/A2 semi-skimmed fresh pasteurised cow milk. Progressive intake of intervention milk as follows:
* Days 1 and 2: 100 mL twice a day
* Days 3 and 4: 150 mL twice a day
* Days 5 and 6: 200 mL twice a day
* Days 7 to 14: 250 mL twice a day Receives: Dietary Supplement: A1/A2 milk 100; Dietary Supplement: A1/A2 milk 150; Dietary Supplement: A1/A2 milk 200; Dietary Supplement: A1/A2 milk 250 |
| A2 milk | Active comparator | Commercial A2 semi-skimmed fresh pasteurised cow milk.
Progressive intake of intervention milk as follows:
* Days 1 and 2: 100 mL twice a day
* Days 3 and 4: 150 mL twice a day
* Days 5 and 6: 200 mL twice a day
* Days 7 to 14: 250 mL twice a day Receives: Dietary Supplement: A2 milk 100; Dietary Supplement: A2 milk 150; Dietary Supplement: A2 milk 200; Dietary Supplement: A2 milk 250 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gastrointestinal inflammation indicated by fecal calprotectin
Measurement of fecal calprotectin (ug/g feces)
Measured: baseline, 14 days, 28 days, 42 days and 56 days
Secondary outcomes (18)
Change in NMR-based urinary metabolic profiles
Measured using High Resolution 700MHz proton NMR spectroscopy (Bruker) (no unit)
Measured: baseline, 14 days, 28 days, 42 days and 56 days
Change in NMR-based plasma metabolic profiles
Measured using High Resolution 700MHz proton NMR spectroscopy (Bruker) (no unit)
Measured: baseline, 14 days, 28 days, 42 days and 56 days
Change in NMR-based fecal metabolic profiles
Measured using High Resolution 700MHz proton NMR spectroscopy (Bruker) (no unit)
Measured: baseline, 14 days, 28 days, 42 days and 56 days
Change in gut microbiota ecosystem assessed by sequencing the 16S rDNA extracted from feces
Measures relative abundance of bacterial taxa
Measured: baseline, 14 days, 28 days, 42 days and 56 days
Change in systemic inflammation indicated by circulating levels of high sensitivity C-reactive protein
hs-CRP in mg/L
Measured: baseline, 14 days, 28 days, 42 days and 56 days
Change in gastrointestinal function assessed using visual analogue scale for GI symptoms
Measures gases, bloating, abdominal cramps, diarrhoea, headache, constipation, nausea and rash
Measured: 14 days
Height (in m) used to detect change in BMI (kg/m^2)
Measured: baseline
Weight (in kg) used to detect change in BMI (kg/m^2)
Measured: baseline, 14 days, 28 days, 42 days and 56 days
Change in systolic blood pressure in mmHg
Measured: baseline, 14 days, 28 days, 42 days and 56 days
Change in diastolic blood pressure in mmHg
Measured: baseline, 14 days, 28 days, 42 days and 56 days
Diagnostic of lactose intolerance by breath hydrogen concentration following ingestion of 25g lactose in 250 mL water
Measured: screening visit, 14 days, 42 days and 56 days
Diagnostic of lactose intolerance by breath methane concentration following ingestion of 25g lactose in 250 mL water
Measured: screening visit, 14 days, 42 days and 56 days
Self-reported change in gut transit time
Measured: 14 days, 42 days and 56 days
Monitoring of changes in psychological behaviour assessed by TMT
Measured: baseline, 14 days, 28 days, 42 days and 56 days
Monitoring of changes in psychological behaviour assessed by Letter Memory Test
Measured: baseline, 14 days, 28 days, 42 days and 56 days
Monitoring of changes in psychological behaviour assessed by Flanger Test
Measured: baseline, 14 days, 28 days, 42 days and 56 days
Monitoring of changes in mood measured by PANAS questionnaire
Measured: baseline, 14 days, 28 days, 42 days and 56 days
Change in stool consistency using the Bristol stool chart
Measured: baseline, 14 days, 28 days, 42 days and 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Apr 2017
- Primary completion30 Apr 2018
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Milk IntoleranceStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandrine Claus, University of Reading
- Investigators
- Sandrine P Claus, PhD, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060395
- Sponsor's protocol ID
- A2study
- Status last verified
- Apr 2020
- First submitted
- 17 Jan 2017
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share IPD with other researchers outside the University of Reading. Anonymous data may be made available upon publication of the study outcome in appropriate repositories (e.g. metabolomic profiles).
Publications
Ul Haq MR, Kapila R, Sharma R, Saliganti V, Kapila S. Comparative evaluation of cow beta-casein variants (A1/A2) consumption on Th2-mediated inflammatory response in mouse gut. Eur J Nutr. 2014 Jun;53(4):1039-49. doi: 10.1007/s00394-013-0606-7. Epub 2013 Oct 29.
PubMed 24166511Ho S, Woodford K, Kukuljan S, Pal S. Comparative effects of A1 versus A2 beta-casein on gastrointestinal measures: a blinded randomised cross-over pilot study. Eur J Clin Nutr. 2014 Sep;68(9):994-1000. doi: 10.1038/ejcn.2014.127. Epub 2014 Jul 2.
PubMed 24986816Jianqin S, Leiming X, Lu X, Yelland GW, Ni J, Clarke AJ. Effects of milk containing only A2 beta casein versus milk containing both A1 and A2 beta casein proteins on gastrointestinal physiology, symptoms of discomfort, and cognitive behavior of people with self-reported intolerance to traditional cows' milk. Nutr J. 2016 Apr 2;15:35. doi: 10.1186/s12937-016-0147-z.
PubMed 27039383Johnson AO, Semenya JG, Buchowski MS, Enwonwu CO, Scrimshaw NS. Correlation of lactose maldigestion, lactose intolerance, and milk intolerance. Am J Clin Nutr. 1993 Mar;57(3):399-401. doi: 10.1093/ajcn/57.3.399.
PubMed 8438774
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of A2 Milk on Gastrointestinal Function of Volunteers Affected by Non-lactose Milk Intolerance
- ClinicalTrials.gov ID
- NCT03060395
- Acronym / sponsor ID
- A2study
- Conditions
- Milk Intolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 23 Feb 2017 (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.
There is increasing evidence that a number of people experience moderate milk intolerance characterised by increased gas production, bloating and abdominal cramp, which can neither be attributed to lactose intolerance, nor to milk protein allergy. Milk digestion can lead to the formation of bioactive peptides, one of which derived from a mutated gene variant (A1) coding for milk beta-casein has been associated with increased gastrointestinal inflammation and poor gastrointestinal function. In this study, we hypothesise that consumption of non-mutated A2 milk will improve gastrointestinal symptoms in non-lactose milk intolerant individuals.
Detailed description
Non-lactose milk intolerance is a condition that has not been defined clinically yet but the current literature reports existence of subjects who are moderately milk intolerant and whose intolerance can neither be attributed to a defect in lactose intolerance, nor to milk protein allergy. Yet, they experience at least one or two of the following symptoms following milk consumption: gases, bloating, abdominal cramp. It is known that the A1gene variant coding for beta-casein leads to the production of a bioactive peptide with opioid activity named betacasomorphin 7 (BCM7). This peptide has been associated with several metabolic health disorders including diabetes, elevated cardiovascular risk and stimulation of pro-inflammatory signals. Recently, it was reported that non-lactose milk intolerant subjects did not experience such symptoms when consuming milk containing the non-mutated A2 gene variant coding for beta-casein. In this study, we hypothesise that consumption of A2 milk will improve gastrointestinal symptoms in non-lactose milk intolerant individuals. The primary outcome of this study will be the reduction of gastrointestinal inflammation following a course of A2 milk consumption.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A1/A2 milk | Sham comparator | Dietary Supplement: A1/A2 milk 100, Dietary Supplement: A1/A2 milk 150, Dietary Supplement: A1/A2 milk 200, Dietary Supplement: A1/A2 milk 250Commercial conventional A1/A2 semi-skimmed fresh pasteurised cow milk. Progressive intake of intervention milk as follows: * Days 1 and 2: 100 mL twice a day * Days 3 and 4: 150 mL twice a day * Days 5 and 6: 200 mL twice a day * Days 7 to 14: 250 mL twice a day |
| A2 milk | Active comparator | Dietary Supplement: A2 milk 100, Dietary Supplement: A2 milk 150, Dietary Supplement: A2 milk 200, Dietary Supplement: A2 milk 250Commercial A2 semi-skimmed fresh pasteurised cow milk. Progressive intake of intervention milk as follows: * Days 1 and 2: 100 mL twice a day * Days 3 and 4: 150 mL twice a day * Days 5 and 6: 200 mL twice a day * Days 7 to 14: 250 mL twice a day |
Who may qualify
- Ages
- 18 to 56 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- BMI: 20-35kg/m2
- Glucose<7mmol/l (not diagnosed with diabetes)
- Total cholesterol<7mmol/l
- Triacylglycerol<4mmol/l
- Normal liver and kidney function
Key exclusion criteria (17 listed)
- Females who are pregnant or planning to be a pregnant and lactating.
- Have known dairy allergy.
- Have stopped drinking milk for the last 6 month.
- Have history of lactose intolerance
- Have history of faecal impaction.
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 |
|---|---|---|
| A2 milk 100Days 1 and 2: 100 mL A2 milk twice a day | Dietary supplement | A2 milk |
| A2 milk 150Days 3 and 4: 150 mL A2 milk twice a day | Dietary supplement | A2 milk |
| A2 milk 200Days 5 and 6: 200 mL A2 milk twice a day | Dietary supplement | A2 milk |
| A2 milk 250Days 7 to 14: 250 mL A2 milk twice a day | Dietary supplement | A2 milk |
| A1/A2 milk 100Days 1 and 2: 100 mL A1/A2 milk twice a day | Dietary supplement | A1/A2 milk |
| A1/A2 milk 150Days 3 and 4: 150 mL A1/A2 milk twice a day | Dietary supplement | A1/A2 milk |
| A1/A2 milk 200Days 5 and 6: 200 mL A1/A2 milk twice a day | Dietary supplement | A1/A2 milk |
| A1/A2 milk 250Days 7 to14: 250 mL A1/A2 milk twice a day | Dietary supplement | A1/A2 milk |
Primary outcome
Change in gastrointestinal inflammation indicated by fecal calprotectin
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Measurement of fecal calprotectin (ug/g feces)
18 secondary outcomes
Change in NMR-based urinary metabolic profiles
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Change in NMR-based plasma metabolic profiles
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Change in NMR-based fecal metabolic profiles
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Change in gut microbiota ecosystem assessed by sequencing the 16S rDNA extracted from feces
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Change in systemic inflammation indicated by circulating levels of high sensitivity C-reactive protein
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Change in gastrointestinal function assessed using visual analogue scale for GI symptoms
Time frame: 14 days
Height (in m) used to detect change in BMI (kg/m^2)
Time frame: baseline
Weight (in kg) used to detect change in BMI (kg/m^2)
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Change in systolic blood pressure in mmHg
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Change in diastolic blood pressure in mmHg
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Diagnostic of lactose intolerance by breath hydrogen concentration following ingestion of 25g lactose in 250 mL water
Time frame: screening visit, 14 days, 42 days and 56 days
Diagnostic of lactose intolerance by breath methane concentration following ingestion of 25g lactose in 250 mL water
Time frame: screening visit, 14 days, 42 days and 56 days
Self-reported change in gut transit time
Time frame: 14 days, 42 days and 56 days
Monitoring of changes in psychological behaviour assessed by TMT
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Monitoring of changes in psychological behaviour assessed by Letter Memory Test
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Monitoring of changes in psychological behaviour assessed by Flanger Test
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Monitoring of changes in mood measured by PANAS questionnaire
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Change in stool consistency using the Bristol stool chart
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
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 28 Apr 2020.
- Background: PubMed 24166511Ul Haq MR, Kapila R, Sharma R, Saliganti V, Kapila S. Comparative evaluation of cow beta-casein variants (A1/A2) consumption on Th2-mediated inflammatory response in mouse gut. Eur J Nutr. 2014 Jun;53(4):1039-49. doi: 10.1007/s00394-013-0606-7. Epub 2013 Oct 29.
- Background: PubMed 24986816Ho S, Woodford K, Kukuljan S, Pal S. Comparative effects of A1 versus A2 beta-casein on gastrointestinal measures: a blinded randomised cross-over pilot study. Eur J Clin Nutr. 2014 Sep;68(9):994-1000. doi: 10.1038/ejcn.2014.127. Epub 2014 Jul 2.
- Background: PubMed 27039383Jianqin S, Leiming X, Lu X, Yelland GW, Ni J, Clarke AJ. Effects of milk containing only A2 beta casein versus milk containing both A1 and A2 beta casein proteins on gastrointestinal physiology, symptoms of discomfort, and cognitive behavior of people with self-reported intolerance to traditional cows' milk. Nutr J. 2016 Apr 2;15:35. doi: 10.1186/s12937-016-0147-z.
- Background: PubMed 8438774Johnson AO, Semenya JG, Buchowski MS, Enwonwu CO, Scrimshaw NS. Correlation of lactose maldigestion, lactose intolerance, and milk intolerance. Am J Clin Nutr. 1993 Mar;57(3):399-401. doi: 10.1093/ajcn/57.3.399.
- Individual participant dataSharing planned: No. We do not plan to share IPD with other researchers outside the University of Reading. Anonymous data may be made available upon publication of the study outcome in appropriate repositories (e.g. metabolomic profiles).
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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.
Sandrine P Claus, PhD principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A2 milk 100, A2 milk 150 and A2 milk 200 in people with Milk Intolerance, run by University of Reading at 1 site in United Kingdom.
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 13 inclusion and 17 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 28 Apr 2020. 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 Kingdom. 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?
Change in gastrointestinal inflammation indicated by fecal calprotectin (time frame: baseline, 14 days, 28 days, 42 days and 56 days). 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 NCT03060395, which also lists 4 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 28 Apr 2020.