Gastrointestinal SymptomsNCT03685552
Safety Evaluation of a Diet and Nutritional Supplementation Program- Purify 2.0
A study testing Prog: Purify-2 in people with Gastrointestinal Symptoms, run by Nature's Sunshine Products, Inc. at 1 site in United States.
Trial summary
The study evaluated the safety, tolerability and acceptability of a lifestyle modification program with nutritional supplementation designed to restore balance to healthy bowel function in generally healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Symptoms
- What is being tested?
- Prog: Purify-2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2017to 13 Sep 2017
- 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 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women ≥ 18 and ≤ 69 years old
- Generally healthy and meeting entrance criteria
- Score ≥ 8 points on the Purify Readiness Scale (Appendix B)
- Willingness to make required lifestyle changes during study participation
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Change in prescription medications, over-the-counter medications, medical foods, and nutritional supplements within 30 days prior to Day 1 and for the duration of the study.
- Use of medications classified as narcotics 15 days prior to Day 1 and for the duration of the study.
- Use of prescription medications and/or over-the-counter medications for acute and semi-acute medical conditions 15 days prior to Day 1 and for the duration of the study. Use of acetaminophen is permitted on an as-needed basis.
- Use of an investigational drug or participation in an investigational study within 30 days prior to Day 1 and for the duration of the study.
- Use of oral or injectable corticosteroids within 30 days prior to Day 1 and for the duration of the study.
- Use of anticoagulant medications (heparin compounds, platelet inhibitors or warfarin) within 30 days prior to Day 1 and for the duration of the study. Use of aspirin 81 mg or 325 mg once daily is permitted.
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- Use of neuro-active prescription medications specifically major and atypical antipsychotic medications within 30 days prior to Day 1 and for the duration of the study.
- Use of prescription medications, over-the-counter medications, medical foods, and nutritional supplements for the treatment of hyperlipidemia within 30 days prior to Day 1 and for the duration of the study.
- Use of prescription medications, over-the-counter medications, medical foods, and nutritional supplements for the treatment of hyperglycemia within 30 days prior to Day 1 and for the duration of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Hughes Center for Research and Innovation
Lehi, Utah, 84043
About this study
Official title: Safety Evaluation of a Diet and Nutritional Supplementation Program for Support of Balanced Bowel Function in Healthy Volunteers
The study evaluated the safety, tolerability and acceptability of a lifestyle modification program with nutritional supplementation designed to restore balance to healthy bowel function in generally healthy subjects
Read the detailed description
To investigate the safety, tolerance and acceptability of a lifestyle modification and targeted nutraceuticals for balanced bowel function in generally healthy volunteers. To evaluate safety and tolerability, blood samples were drawn for blood counts, metabolic profiles, plasma lipids, and additional cardiovascular risk factors. Quality of life questionnaires, medical symptom questionnaire were evaluated at baseline, week 1, week 2 and week 4. Vitals signs, weight and body composition were monitored at each visit.
- Conditions
- Gastrointestinal Symptoms
- Being tested
- Prog: Purify-2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prog: Purify-2Other
Nutritional Supplements to be administered:
- Protein Shakes: one protein shake twice a day
- Probiotics (Bacillus Coagulans) once a day
- Biome NO+ ( blend of amino acids, specifically l-arginine and l-citrulline, combined with red beet root, grape polyphenol extract, vitamins and minerals) twice a day
- In.Form Purify ( blend of psyllium hull, inulin, L-glutamine, fruit, fruit extracts and zinc) twice a day
| Study group | Role | What they receive |
|---|---|---|
| Prog: Purify-2 | Experimental | All subjects will be participating in a diet life style modification program (High Phytopro dietary program) ( a modified Mediterranean style low glycemic load food plan) and will be receiving a supportive nutritional supplements over a 4 week period. Receives: Other: Prog: Purify-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0).
Data collection at individual and group visits and physician interviews at individual visits (baseline, week 1, week 2 and week 4) will be used to assess participants for treatment-related adverse events. Subjects with ongoing AEs may be followed for an additional 4 weeks at the discretion of the PI.
Measured: 4 weeks
Secondary outcomes (28)
Changes in Quality of life questionnaire [Medical Outcomes Study-Short Form 36 (MOS-SF36)] compared to baseline
The clinician will review the Medical Outcomes Study-Short Form 36 (MOS-SF36)] at individual visits (baseline, week 1, week 2 and week 4).
Measured: 4 weeks
Changes in gastrointestinal Quality of Life questionnaire with Bristol Stool Chart scores compared to baseline
The clinician will review the Gastrointestinal Quality of Life questionnaire with Bristol Stool Chart scores at individual visits (baseline, week 1, week 2 and week 4).
Measured: 4 weeks
Changes in Medical Symptom Questionnaire compared to baseline
The clinician will review the Medical Symptom Questionnaire at individual visits (baseline, week 1, week 2 and week 4).
Measured: 4 weeks
Number of participants with treatment-related changes in basic safety labs
Phlebotomy will be conducted at individual visits (baseline, week 1, week 2 and week 4).
Comprehensive Metabolic Panels (CMP) including ALT (Alanine aminotransferase), AST(aspartate aminotransferase) and Complete Blood Counts (CBC) will be assessed for treatment-related change from baseline.
Measured: 4 weeks
Changes in blood pressure and peripheral pulse compared to baseline
Blood pressure and peripheral pulse will be monitored at individual visits (baseline, week 1, week 2 and week 4).
Measured: 4 weeks
Changes in weight in pounds compared to baseline
Weight in pounds will be monitored at individual visits (baseline, week 1, week 2 and week 4).
Measured: 4 weeks
Changes in body fat in percentage compared to baseline
Body fat in percentage will be monitored at individual visits (baseline, week 1, week 2 and week 4).
Measured: 4 weeks
Changes in body mass index (BMI) in kg/m2 compared to baseline
Body mass will be monitored at individual visits (baseline, week 1, week 2 and week 4).
Measured: 4 weeks
Changes in waist circumference in inches compared to baseline
Body mass will be monitored at individual visits (baseline, week 1, week 2 and week 4).
Measured: 4 weeks
Changes in lipid panel compared to baseline
Lipid panel will be measured at individual visits (baseline, week 1, week 2 and week 4).
Measured: 4 weeks
Changes in inflammatory marker (high sensitivity C-reactive protein (hs-CRP) in mg/L) to identify low levels of inflammation that can be associated with conditions like cardiovascular disease compared to baseline
hs-CRP will be measured at individual visits (baseline, week 1, week 2 and week 4).
Measured: 4 weeks
Changes in Gammaglutamyl transferase (GGT) in U/L compared to baseline
GGT will be measured at individual visits (baseline, week 1, week 2 and week 4).
Measured: 4 weeks
Changes in fasting Glucose and Insulin compared to baseline
Glucose and Insulin will be measured at individual visits (baseline, week 1, week 2 and week 4).
Measured: 4 weeks
Changes in inflammatory markers levels including calprotectin, secretory Immunoglobulin A (IgA), and eosinophil-derived neurotoxin
Calprotectin, secretory IgA, and eosinophil-derived neurotoxin will be measured at individual visits (baseline, week 1, week 2 and week 4).
Measured: 4 weeks
Changes in myeloperoxidase (MPO) levels compared to baseline
MPO will be measured at individual visits (baseline, week 1, week 2 and week 4).
Measured: 4 weeks
Changes in Heme Oxygenase-1 (HO-1) levels in ng/ml compared to baseline
(HO-1) will be measured at individual visits (baseline, week 1, week 2 and week 4).
Measured: 4 weeks
Changes in total branch chain amino acids levels compared to baseline
Total branch amino acids will be measured at individual visits (baseline, week 1, week 2 and week 4).
Measured: 4 weeks
Changes in Trimethylamine N-oxide/ Asymmetric dimethylarginine/ Symmetric dimethylarginine (TMAO/ADMA/SDMA) levels compared to baseline
TMAO/ADMA/SDMA will be measured at individual visits (baseline, week 1, week 2 and week 4).
Measured: 4 weeks
Changes in sodium copper chlorophyllin levels compared to baseline
Chlorophyllin will be measured at individual visits (baseline, week 1, week 2 and week 4).
Measured: 4 weeks
Changes in metallothionein protein levels compared to baseline
Metallothionein will be measured at individual visits (baseline, week 1, week 2 and week 4).
Measured: 4 weeks
Changes in Thiobarbituric acid (TBARS/Malondialdehyde) compared to baseline
TBARS will be measured at individual visits (baseline, week 1, week 2 and week 4).
Measured: 4 weeks
Changes in Total Antioxidant Capacity (TAC) levels as Trolox Equivalent (TE) compared to baseline
TAC will be measured at individual visits (baseline, week 1, week 2 and week 4).
Measured: 4 weeks
Changes in serum Zonulin levels compared to baseline
Zonulin will be measured at individual visits (baseline, week 1, week 2 and week 4).
Measured: 4 weeks
Changes in Lactulose/Mannitol ratio in 24-hour urine collected samples compared to baseline
Lactulose/Mannitol ratio will be measured at individual visits (baseline, week 1, week 2 and week 4).
Measured: 4 weeks
Changes in urine toxic element levels compared to baseline
Toxic element levels will be measured at individual visits (baseline, week 1, week 2 and week 4).
Measured: 4 weeks
Changes in stool Zonulin levels compared to baseline
Stool Zonulin will be measured at individual visits (baseline, week 1, week 2 and week 4).
Measured: 4 weeks
Changes in stool short chain fatty acids (SCFAs) levels including n-butyrate, propionate and acetate compared to baseline
SCFAs levels will be measured at individual visits (baseline, week 1, week 2 and week 4).
Measured: 4 weeks
Changes in stool Firmicutes count, Bacteroidetes count, and Firmicutes/Bacteroidetes ratio compared to baseline
stool Firmicutes count, Bacteroidetes count, and Firmicutes/Bacteroidetes ratio will be measured at individual visits (baseline, week 1, week 2 and week 4).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start3 Aug 2017
- Primary completion13 Sep 2017
- Study completion13 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal SymptomsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nature's Sunshine Products, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph J Lamb, MD, Principal investigator, Hughes Center for Research and Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685552
- Sponsor's protocol ID
- NSP-CT-012
- Status last verified
- Sep 2018
- First submitted
- 20 Sep 2018
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Delzenne NM, Cani PD. Interaction between obesity and the gut microbiota: relevance in nutrition. Annu Rev Nutr. 2011 Aug 21;31:15-31. doi: 10.1146/annurev-nutr-072610-145146.
PubMed 21568707de Vrese M, Schrezenmeir J. Probiotics, prebiotics, and synbiotics. Adv Biochem Eng Biotechnol. 2008;111:1-66. doi: 10.1007/10_2008_097.
PubMed 18461293Macfarlane GT, Steed H, Macfarlane S. Bacterial metabolism and health-related effects of galacto-oligosaccharides and other prebiotics. J Appl Microbiol. 2008 Feb;104(2):305-44. doi: 10.1111/j.1365-2672.2007.03520.x.
PubMed 18215222Roberfroid M, Gibson GR, Hoyles L, McCartney AL, Rastall R, Rowland I, Wolvers D, Watzl B, Szajewska H, Stahl B, Guarner F, Respondek F, Whelan K, Coxam V, Davicco MJ, Leotoing L, Wittrant Y, Delzenne NM, Cani PD, Neyrinck AM, Meheust A. Prebiotic effects: metabolic and health benefits. Br J Nutr. 2010 Aug;104 Suppl 2:S1-63. doi: 10.1017/S0007114510003363.
PubMed 20920376Lamb JJ, Konda VR, Quig DW, Desai A, Minich DM, Bouillon L, Chang JL, Hsi A, Lerman RH, Kornberg J, Bland JS, Tripp ML. A program consisting of a phytonutrient-rich medical food and an elimination diet ameliorated fibromyalgia symptoms and promoted toxic-element detoxification in a pilot trial. Altern Ther Health Med. 2011 Mar-Apr;17(2):36-44.
PubMed 21717823
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Evaluation of a Diet and Nutritional Supplementation Program for Support of Balanced Bowel Function in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03685552
- Acronym / sponsor ID
- NSP-CT-012
- Conditions
- Gastrointestinal Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Nature's Sunshine Products, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Aug 2017 (actual)
- Primary completion
- 13 Sep 2017 (actual)
- Study completion
- 13 Sep 2017 (actual)
- First posted
- 26 Sep 2018 (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.
The study evaluated the safety, tolerability and acceptability of a lifestyle modification program with nutritional supplementation designed to restore balance to healthy bowel function in generally healthy subjects
Detailed description
To investigate the safety, tolerance and acceptability of a lifestyle modification and targeted nutraceuticals for balanced bowel function in generally healthy volunteers. To evaluate safety and tolerability, blood samples were drawn for blood counts, metabolic profiles, plasma lipids, and additional cardiovascular risk factors. Quality of life questionnaires, medical symptom questionnaire were evaluated at baseline, week 1, week 2 and week 4. Vitals signs, weight and body composition were monitored at each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prog: Purify-2 | Experimental | Other: Prog: Purify-2All subjects will be participating in a diet life style modification program (High Phytopro dietary program) ( a modified Mediterranean style low glycemic load food plan) and will be receiving a supportive nutritional supplements over a 4 week period. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women ≥ 18 and ≤ 69 years old
- Generally healthy and meeting entrance criteria
- Score ≥ 8 points on the Purify Readiness Scale (Appendix B)
- Willingness to make required lifestyle changes during study participation
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (9 listed)
- Change in prescription medications, over-the-counter medications, medical foods, and nutritional supplements within 30 days prior to Day 1 and for the duration of the study.
- Use of medications classified as narcotics 15 days prior to Day 1 and for the duration of the study.
- Use of prescription medications and/or over-the-counter medications for acute and semi-acute medical conditions 15 days prior to Day 1 and for the duration of the study. Use of acetaminophen is permitted on an as-needed basis.
- Use of an investigational drug or participation in an investigational study within 30 days prior to Day 1 and for the duration of the study.
- Use of oral or injectable corticosteroids within 30 days prior to Day 1 and for the duration of the study.
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 |
|---|---|---|
| Prog: Purify-2Nutritional Supplements to be administered: * Protein Shakes: one protein shake twice a day * Probiotics (Bacillus Coagulans) once a day * Biome NO+ ( blend of amino acids, specifically l-arginine and l-citrulline, combined with red beet root, grape polyphenol extract, vitamins and minerals) twice a day * In.Form Purify ( blend of psyllium hull, inulin, L-glutamine, fruit, fruit extracts and zinc) twice a day | Other | Prog: Purify-2 |
Primary outcome
Number of participants with treatment-related adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0).
Time frame: 4 weeks
Data collection at individual and group visits and physician interviews at individual visits (baseline, week 1, week 2 and week 4) will be used to assess participants for treatment-related adverse events. Subjects with ongoing AEs may be followed for an additional 4 weeks at the discretion of the PI.
28 secondary outcomes
Changes in Quality of life questionnaire [Medical Outcomes Study-Short Form 36 (MOS-SF36)] compared to baseline
Time frame: 4 weeks
Changes in gastrointestinal Quality of Life questionnaire with Bristol Stool Chart scores compared to baseline
Time frame: 4 weeks
Changes in Medical Symptom Questionnaire compared to baseline
Time frame: 4 weeks
Number of participants with treatment-related changes in basic safety labs
Time frame: 4 weeks
Changes in blood pressure and peripheral pulse compared to baseline
Time frame: 4 weeks
Changes in weight in pounds compared to baseline
Time frame: 4 weeks
Changes in body fat in percentage compared to baseline
Time frame: 4 weeks
Changes in body mass index (BMI) in kg/m2 compared to baseline
Time frame: 4 weeks
Changes in waist circumference in inches compared to baseline
Time frame: 4 weeks
Changes in lipid panel compared to baseline
Time frame: 4 weeks
Changes in inflammatory marker (high sensitivity C-reactive protein (hs-CRP) in mg/L) to identify low levels of inflammation that can be associated with conditions like cardiovascular disease compared to baseline
Time frame: 4 weeks
Changes in Gammaglutamyl transferase (GGT) in U/L compared to baseline
Time frame: 4 weeks
Changes in fasting Glucose and Insulin compared to baseline
Time frame: 4 weeks
Changes in inflammatory markers levels including calprotectin, secretory Immunoglobulin A (IgA), and eosinophil-derived neurotoxin
Time frame: 4 weeks
Changes in myeloperoxidase (MPO) levels compared to baseline
Time frame: 4 weeks
Changes in Heme Oxygenase-1 (HO-1) levels in ng/ml compared to baseline
Time frame: 4 weeks
Changes in total branch chain amino acids levels compared to baseline
Time frame: 4 weeks
Changes in Trimethylamine N-oxide/ Asymmetric dimethylarginine/ Symmetric dimethylarginine (TMAO/ADMA/SDMA) levels compared to baseline
Time frame: 4 weeks
Changes in sodium copper chlorophyllin levels compared to baseline
Time frame: 4 weeks
Changes in metallothionein protein levels compared to baseline
Time frame: 4 weeks
Changes in Thiobarbituric acid (TBARS/Malondialdehyde) compared to baseline
Time frame: 4 weeks
Changes in Total Antioxidant Capacity (TAC) levels as Trolox Equivalent (TE) compared to baseline
Time frame: 4 weeks
Changes in serum Zonulin levels compared to baseline
Time frame: 4 weeks
Changes in Lactulose/Mannitol ratio in 24-hour urine collected samples compared to baseline
Time frame: 4 weeks
Changes in urine toxic element levels compared to baseline
Time frame: 4 weeks
Changes in stool Zonulin levels compared to baseline
Time frame: 4 weeks
Changes in stool short chain fatty acids (SCFAs) levels including n-butyrate, propionate and acetate compared to baseline
Time frame: 4 weeks
Changes in stool Firmicutes count, Bacteroidetes count, and Firmicutes/Bacteroidetes ratio compared to baseline
Time frame: 4 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 26 Sep 2018.
- Background: PubMed 21568707Delzenne NM, Cani PD. Interaction between obesity and the gut microbiota: relevance in nutrition. Annu Rev Nutr. 2011 Aug 21;31:15-31. doi: 10.1146/annurev-nutr-072610-145146.
- Background: PubMed 18461293de Vrese M, Schrezenmeir J. Probiotics, prebiotics, and synbiotics. Adv Biochem Eng Biotechnol. 2008;111:1-66. doi: 10.1007/10_2008_097.
- Background: PubMed 18215222Macfarlane GT, Steed H, Macfarlane S. Bacterial metabolism and health-related effects of galacto-oligosaccharides and other prebiotics. J Appl Microbiol. 2008 Feb;104(2):305-44. doi: 10.1111/j.1365-2672.2007.03520.x.
- Background: PubMed 20920376Roberfroid M, Gibson GR, Hoyles L, McCartney AL, Rastall R, Rowland I, Wolvers D, Watzl B, Szajewska H, Stahl B, Guarner F, Respondek F, Whelan K, Coxam V, Davicco MJ, Leotoing L, Wittrant Y, Delzenne NM, Cani PD, Neyrinck AM, Meheust A. Prebiotic effects: metabolic and health benefits. Br J Nutr. 2010 Aug;104 Suppl 2:S1-63. doi: 10.1017/S0007114510003363.
- Background: PubMed 21717823Lamb JJ, Konda VR, Quig DW, Desai A, Minich DM, Bouillon L, Chang JL, Hsi A, Lerman RH, Kornberg J, Bland JS, Tripp ML. A program consisting of a phytonutrient-rich medical food and an elimination diet ameliorated fibromyalgia symptoms and promoted toxic-element detoxification in a pilot trial. Altern Ther Health Med. 2011 Mar-Apr;17(2):36-44.
- 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.
Joseph J Lamb, MD principal investigator
Hughes Center for Research and Innovation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prog: Purify-2 in people with Gastrointestinal Symptoms, run by Nature's Sunshine Products, Inc. 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 5 inclusion and 9 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 26 Sep 2018. 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. 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?
Number of participants with treatment-related adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0). (time frame: 4 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 NCT03685552, which also lists 5 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 26 Sep 2018.