Obesity (Disorder)NCT03412149
Three M Study (Malabsorption, Microbiota, Mini-Gastric Bypass)
A study testing Mini Gastric Bypass and Roux en Y Gastric Bypass in people with Obesity (Disorder), run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
Bariatric surgery represents the best therapeutic option to induce sustainable weight loss and to solve serious comorbidities improving the life-expectancy and the quality of life. Actually the choice of the procedure is based on the surgeon's and patients preference . Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity (Disorder)
- What is being tested?
- Mini Gastric Bypass and Roux en Y Gastric Bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 21 Mar 2018to 19 Nov 2020
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 40-55 kg/m2
- Non smokers
- Primary Mini Gastric Bypass or Roux en Y Gastric Bypass without any concomitant surgeries except hiatal hernia repair
- Enrollment in the two study groups will be on the basis of patient choice.
Who cannot join
- Smokers
- Different bowel measurement (plus or minus 10%).
- Conversion to open surgery, reoperation
- Helicobacter Pylori positive previous or current
- Free PPI 4 weeks before 6th month (after surgery)
- Corticosteroids, vitamine E, fish oil treatment 2 months before surgery
Show all 13Show fewer
- Anti or pre- biotics treatment 2 months before surgery
- Chronic gastrointestinal diseases or syndromes
- Previous bariatric surgery (intragastric balloon excluded)
- Previous resective bowel surgery
- Previous pancreatic surgery
- Previous Hepato BilioPancreatic surgery
- Gallbladder gallstones
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Malabsorption and Gut Microbiota Profile Changes After Laparoscopic Mini-Gastric Bypass (MGB) vs Roux-en-Y Gastric Bypass (RYGB): a Prospective Multicenter Comparative Study
Bariatric surgery represents the best therapeutic option to induce sustainable weight loss and to solve serious comorbidities improving the life-expectancy and the quality of life. Actually the choice of the procedure is based on the surgeon's and patients preference . Mini gastric bypass(MGB) is an emerging procedure offering excellent results in terms of weight loss and comorbidities (mainly metabolic) control. On the other hand, recent data indicated that the gut microbiota may mediate some of the beneficial effects of bariatric surgery and changes in the composition and diversity of the gut microbiota have been observed after RY Gastric Bypass (RYGB) in humans as well as in mice. However, there are no prospective investigations on Gut Microbiota changes after MGB, despite the procedure is described as "malabsorptive" and there are no studies comparing gut microbiota shift and malabsorption entity in humans after RYGB vs MGB. Thereafter prospective data on the incidence of bile reflux esophageal lesions after MGB are lacking.
The aim of the present multicentric prospective comparative study is to evaluate malabsorption and gut microbiota shift after laparoscopic RYGB vs MGB at 1 year.
- Conditions
- Obesity (Disorder)
- Being tested
- Mini Gastric Bypass, Roux en Y Gastric Bypass
- Keywords
- Malabsorption, Mini Gastric Bypass, Roux en Y Gastric Bypass
- Medical subject headings
- Obesity, Malabsorption Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini Gastric BypassProcedure or surgery
Standardization of the techniques will be guaranteed:
- Mini Gastric Bypass Arm
- Roux en Y Gastric Bypass arm All patients will have intraoperative measurement of the whole length of bowel from Treitz ligament to the ileocecal junction (expected range 6-8 m).The common limb will be therefore about 2/3 of total small bowel length.
Roux en Y Gastric BypassProcedure or surgery
Standardization of the techniques will be guaranteed:
- Mini Gastric Bypass Arm
- Roux en Y Gastric Bypass arm All patients will have intraoperative measurement of the whole length of bowel from Treitz ligament to the ileocecal junction (expected range 6-8 m).The common limb will be therefore about 2/3 of total small bowel length.
| Study group | Role | What they receive |
|---|---|---|
| Mini Gastric Bypass | Active comparator | Mini Gastric Bypass: The gastric pouch will be performed starting below the incisura angularis (transverse resection 4 cm) on the lesser curvature (18).Then the stomach will be transected against a 36 Fr bougie up to the gastro-esophageal junction Then 1/3 of the small bowel will be excluded (approximately 200cms) and 3.5-4 cm gastro-jejunostomy will be performed by linear stapler. Receives: Procedure: Mini Gastric Bypass |
| Roux en Y Gastric Bypass | Active comparator | Roux en Y Gastric Bypass: The steps of the standard double loop RYGB technique will be followed (17). The gastric pouch will be created 7 cm from the gastro-esophageal junction to obtain a volume of 30-40 ml, and the length of the alimentary limb will be 150 cm and 3.5-4 cm gastro-jejunostomy will be performed by linear stapler. The length of the biliopancreatic limb will be from 65 to 75 cm beyond the ligament of Treitz. The lengths of both limbs should carefully measured with a graduated instrument. The mesenteric defects will be closed. Receives: Procedure: Roux en Y Gastric Bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut Microbiota
To evaluate and compare Roux en Y Gastric Bypass vs Mini Gastric Bypass microbiota profile shift 1 year after surgery and its impact on metabolic and nutritional status after surgery.
Measured: 0-6-12 Months
Secondary outcomes (1)
Glucagon - like peptide 1 (GLP-1)
To measure GLP-1 plasma level before and 12 months after surgery in MGB vs RYGB patients
Measured: 0-12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start21 Mar 2018
- Primary completion19 Feb 2020
- Study completion19 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Obesity (Disorder)Studies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianfranco Silecchia, University of Roma La Sapienza
- Investigators
- Gianfranco Silecchia, MD PhD, Principal investigator, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412149
- Sponsor's protocol ID
- RG11715C7CE1AD8A
- Status last verified
- Apr 2021
- First submitted
- 24 Dec 2017
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Milone M, De Placido G, Musella M, Sosa Fernandez LM, Sosa Fernandez LV, Campana G, Di Minno MN, Milone F. Incidence of Successful Pregnancy After Weight Loss Interventions in Infertile Women: a Systematic Review and Meta-Analysis of the Literature. Obes Surg. 2016 Feb;26(2):443-51. doi: 10.1007/s11695-015-1998-7.
PubMed 26661108Musella M, Apers J, Rheinwalt K, Ribeiro R, Manno E, Greco F, Cierny M, Milone M, Di Stefano C, Guler S, Van Lessen IM, Guerra A, Maglio MN, Bonfanti R, Novotna R, Coretti G, Piazza L. Efficacy of Bariatric Surgery in Type 2 Diabetes Mellitus Remission: the Role of Mini Gastric Bypass/One Anastomosis Gastric Bypass and Sleeve Gastrectomy at 1 Year of Follow-up. A European survey. Obes Surg. 2016 May;26(5):933-40. doi: 10.1007/s11695-015-1865-6.
PubMed 26341086Campanile FC, Boru CE, Rizzello M, Puzziello A, Copaescu C, Cavallaro G, Silecchia G. Acute complications after laparoscopic bariatric procedures: update for the general surgeon. Langenbecks Arch Surg. 2013 Jun;398(5):669-86. doi: 10.1007/s00423-013-1077-2. Epub 2013 Mar 22.
PubMed 23519905Rutledge R. The mini-gastric bypass: experience with the first 1,274 cases. Obes Surg. 2001 Jun;11(3):276-80. doi: 10.1381/096089201321336584.
PubMed 11433900Rutledge R, Walsh TR. Continued excellent results with the mini-gastric bypass: six-year study in 2,410 patients. Obes Surg. 2005 Oct;15(9):1304-8. doi: 10.1381/096089205774512663.
PubMed 16259892Alexandrou A, Davis PA, Law S, Whooley BP, Murthy SC, Wong J. Esophageal cancer in patients with a history of distal gastrectomy. Arch Surg. 2002 Nov;137(11):1238-42. doi: 10.1001/archsurg.137.11.1238.
PubMed 12413309Lee WJ, Ser KH, Lee YC, Tsou JJ, Chen SC, Chen JC. Laparoscopic Roux-en-Y vs. mini-gastric bypass for the treatment of morbid obesity: a 10-year experience. Obes Surg. 2012 Dec;22(12):1827-34. doi: 10.1007/s11695-012-0726-9.
PubMed 23011462Bruzzi M, Rau C, Voron T, Guenzi M, Berger A, Chevallier JM. Single anastomosis or mini-gastric bypass: long-term results and quality of life after a 5-year follow-up. Surg Obes Relat Dis. 2015 Mar-Apr;11(2):321-6. doi: 10.1016/j.soard.2014.09.004. Epub 2014 Sep 16.
PubMed 25614356Noun R, Skaff J, Riachi E, Daher R, Antoun NA, Nasr M. One thousand consecutive mini-gastric bypass: short- and long-term outcome. Obes Surg. 2012 May;22(5):697-703. doi: 10.1007/s11695-012-0618-z.
PubMed 22411569Lee WJ, Lee YC, Ser KH, Chen SC, Chen JC, Su YH. Revisional surgery for laparoscopic minigastric bypass. Surg Obes Relat Dis. 2011 Jul-Aug;7(4):486-91. doi: 10.1016/j.soard.2010.10.012. Epub 2010 Oct 30.
PubMed 21159561Wang W, Wei PL, Lee YC, Huang MT, Chiu CC, Lee WJ. Short-term results of laparoscopic mini-gastric bypass. Obes Surg. 2005 May;15(5):648-54. doi: 10.1381/0960892053923752.
PubMed 15946455Cavin JB, Voitellier E, Cluzeaud F, Kapel N, Marmuse JP, Chevallier JM, Msika S, Bado A, Le Gall M. Malabsorption and intestinal adaptation after one anastomosis gastric bypass compared with Roux-en-Y gastric bypass in rats. Am J Physiol Gastrointest Liver Physiol. 2016 Sep 1;311(3):G492-500. doi: 10.1152/ajpgi.00197.2016. Epub 2016 Jul 14.
PubMed 27418681Graessler J, Qin Y, Zhong H, Zhang J, Licinio J, Wong ML, Xu A, Chavakis T, Bornstein AB, Ehrhart-Bornstein M, Lamounier-Zepter V, Lohmann T, Wolf T, Bornstein SR. Metagenomic sequencing of the human gut microbiome before and after bariatric surgery in obese patients with type 2 diabetes: correlation with inflammatory and metabolic parameters. Pharmacogenomics J. 2013 Dec;13(6):514-22. doi: 10.1038/tpj.2012.43. Epub 2012 Oct 2.
PubMed 23032991Tremaroli V, Karlsson F, Werling M, Stahlman M, Kovatcheva-Datchary P, Olbers T, Fandriks L, le Roux CW, Nielsen J, Backhed F. Roux-en-Y Gastric Bypass and Vertical Banded Gastroplasty Induce Long-Term Changes on the Human Gut Microbiome Contributing to Fat Mass Regulation. Cell Metab. 2015 Aug 4;22(2):228-38. doi: 10.1016/j.cmet.2015.07.009.
PubMed 26244932Liou AP, Paziuk M, Luevano JM Jr, Machineni S, Turnbaugh PJ, Kaplan LM. Conserved shifts in the gut microbiota due to gastric bypass reduce host weight and adiposity. Sci Transl Med. 2013 Mar 27;5(178):178ra41. doi: 10.1126/scitranslmed.3005687.
PubMed 23536013
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malabsorption and Gut Microbiota Profile Changes After Laparoscopic Mini-Gastric Bypass (MGB) vs Roux-en-Y Gastric Bypass (RYGB): a Prospective Multicenter Comparative Study
- ClinicalTrials.gov ID
- NCT03412149
- Acronym / sponsor ID
- RG11715C7CE1AD8A
- Conditions
- Obesity (Disorder)
- Keywords
- Malabsorption, Mini Gastric Bypass, Roux en Y Gastric Bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 21 Mar 2018 (actual)
- Primary completion
- 19 Feb 2020 (actual)
- Study completion
- 19 Nov 2020 (actual)
- First posted
- 26 Jan 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.
Bariatric surgery represents the best therapeutic option to induce sustainable weight loss and to solve serious comorbidities improving the life-expectancy and the quality of life. Actually the choice of the procedure is based on the surgeon's and patients preference . Mini gastric bypass(MGB) is an emerging procedure offering excellent results in terms of weight loss and comorbidities (mainly metabolic) control. On the other hand, recent data indicated that the gut microbiota may mediate some of the beneficial effects of bariatric surgery and changes in the composition and diversity of the gut microbiota have been observed after RY Gastric Bypass (RYGB) in humans as well as in mice. However, there are no prospective investigations on Gut Microbiota changes after MGB, despite the procedure is described as "malabsorptive" and there are no studies comparing gut microbiota shift and malabsorption entity in humans after RYGB vs MGB. Thereafter prospective data on the incidence of bile reflux esophageal lesions after MGB are lacking.
The aim of the present multicentric prospective comparative study is to evaluate malabsorption and gut microbiota shift after laparoscopic RYGB vs MGB at 1 year.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mini Gastric Bypass | Active comparator | Procedure: Mini Gastric BypassMini Gastric Bypass: The gastric pouch will be performed starting below the incisura angularis (transverse resection 4 cm) on the lesser curvature (18).Then the stomach will be transected against a 36 Fr bougie up to the gastro-esophageal junction Then 1/3 of the small bowel will be excluded (approximately 200cms) and 3.5-4 cm gastro-jejunostomy will be performed by linear stapler. |
| Roux en Y Gastric Bypass | Active comparator | Procedure: Roux en Y Gastric BypassRoux en Y Gastric Bypass: The steps of the standard double loop RYGB technique will be followed (17). The gastric pouch will be created 7 cm from the gastro-esophageal junction to obtain a volume of 30-40 ml, and the length of the alimentary limb will be 150 cm and 3.5-4 cm gastro-jejunostomy will be performed by linear stapler. The length of the biliopancreatic limb will be from 65 to 75 cm beyond the ligament of Treitz. The lengths of both limbs should carefully measured with a graduated instrument. The mesenteric defects will be closed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI 40-55 kg/m2
- Non smokers
- Primary Mini Gastric Bypass or Roux en Y Gastric Bypass without any concomitant surgeries except hiatal hernia repair
- Enrollment in the two study groups will be on the basis of patient choice.
Key exclusion criteria (13 listed)
- Smokers
- Different bowel measurement (plus or minus 10%).
- Conversion to open surgery, reoperation
- Helicobacter Pylori positive previous or current
- Free PPI 4 weeks before 6th month (after surgery)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mini Gastric BypassStandardization of the techniques will be guaranteed: 1. Mini Gastric Bypass Arm 2. Roux en Y Gastric Bypass arm All patients will have intraoperative measurement of the whole length of bowel from Treitz ligament to the ileocecal junction (expected range 6-8 m).The common limb will be therefore about 2/3 of total small bowel length. | Procedure or surgery | Mini Gastric Bypass |
| Roux en Y Gastric BypassStandardization of the techniques will be guaranteed: 1. Mini Gastric Bypass Arm 2. Roux en Y Gastric Bypass arm All patients will have intraoperative measurement of the whole length of bowel from Treitz ligament to the ileocecal junction (expected range 6-8 m).The common limb will be therefore about 2/3 of total small bowel length. | Procedure or surgery | Roux en Y Gastric Bypass |
Primary outcome
Gut Microbiota
Time frame: 0-6-12 Months
To evaluate and compare Roux en Y Gastric Bypass vs Mini Gastric Bypass microbiota profile shift 1 year after surgery and its impact on metabolic and nutritional status after surgery.
1 secondary outcome
Glucagon - like peptide 1 (GLP-1)
Time frame: 0-12 Months
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 2021.
- Background: PubMed 26661108Milone M, De Placido G, Musella M, Sosa Fernandez LM, Sosa Fernandez LV, Campana G, Di Minno MN, Milone F. Incidence of Successful Pregnancy After Weight Loss Interventions in Infertile Women: a Systematic Review and Meta-Analysis of the Literature. Obes Surg. 2016 Feb;26(2):443-51. doi: 10.1007/s11695-015-1998-7.
- Background: PubMed 26341086Musella M, Apers J, Rheinwalt K, Ribeiro R, Manno E, Greco F, Cierny M, Milone M, Di Stefano C, Guler S, Van Lessen IM, Guerra A, Maglio MN, Bonfanti R, Novotna R, Coretti G, Piazza L. Efficacy of Bariatric Surgery in Type 2 Diabetes Mellitus Remission: the Role of Mini Gastric Bypass/One Anastomosis Gastric Bypass and Sleeve Gastrectomy at 1 Year of Follow-up. A European survey. Obes Surg. 2016 May;26(5):933-40. doi: 10.1007/s11695-015-1865-6.
- Background: PubMed 23519905Campanile FC, Boru CE, Rizzello M, Puzziello A, Copaescu C, Cavallaro G, Silecchia G. Acute complications after laparoscopic bariatric procedures: update for the general surgeon. Langenbecks Arch Surg. 2013 Jun;398(5):669-86. doi: 10.1007/s00423-013-1077-2. Epub 2013 Mar 22.
- Background: PubMed 11433900Rutledge R. The mini-gastric bypass: experience with the first 1,274 cases. Obes Surg. 2001 Jun;11(3):276-80. doi: 10.1381/096089201321336584.
- Background: PubMed 16259892Rutledge R, Walsh TR. Continued excellent results with the mini-gastric bypass: six-year study in 2,410 patients. Obes Surg. 2005 Oct;15(9):1304-8. doi: 10.1381/096089205774512663.
- Background: PubMed 12413309Alexandrou A, Davis PA, Law S, Whooley BP, Murthy SC, Wong J. Esophageal cancer in patients with a history of distal gastrectomy. Arch Surg. 2002 Nov;137(11):1238-42. doi: 10.1001/archsurg.137.11.1238.
- Background: PubMed 23011462Lee WJ, Ser KH, Lee YC, Tsou JJ, Chen SC, Chen JC. Laparoscopic Roux-en-Y vs. mini-gastric bypass for the treatment of morbid obesity: a 10-year experience. Obes Surg. 2012 Dec;22(12):1827-34. doi: 10.1007/s11695-012-0726-9.
- Background: PubMed 25614356Bruzzi M, Rau C, Voron T, Guenzi M, Berger A, Chevallier JM. Single anastomosis or mini-gastric bypass: long-term results and quality of life after a 5-year follow-up. Surg Obes Relat Dis. 2015 Mar-Apr;11(2):321-6. doi: 10.1016/j.soard.2014.09.004. Epub 2014 Sep 16.
- Background: PubMed 22411569Noun R, Skaff J, Riachi E, Daher R, Antoun NA, Nasr M. One thousand consecutive mini-gastric bypass: short- and long-term outcome. Obes Surg. 2012 May;22(5):697-703. doi: 10.1007/s11695-012-0618-z.
- Background: PubMed 21159561Lee WJ, Lee YC, Ser KH, Chen SC, Chen JC, Su YH. Revisional surgery for laparoscopic minigastric bypass. Surg Obes Relat Dis. 2011 Jul-Aug;7(4):486-91. doi: 10.1016/j.soard.2010.10.012. Epub 2010 Oct 30.
- Background: PubMed 15946455Wang W, Wei PL, Lee YC, Huang MT, Chiu CC, Lee WJ. Short-term results of laparoscopic mini-gastric bypass. Obes Surg. 2005 May;15(5):648-54. doi: 10.1381/0960892053923752.
- Background: PubMed 27418681Cavin JB, Voitellier E, Cluzeaud F, Kapel N, Marmuse JP, Chevallier JM, Msika S, Bado A, Le Gall M. Malabsorption and intestinal adaptation after one anastomosis gastric bypass compared with Roux-en-Y gastric bypass in rats. Am J Physiol Gastrointest Liver Physiol. 2016 Sep 1;311(3):G492-500. doi: 10.1152/ajpgi.00197.2016. Epub 2016 Jul 14.
- Individual participant dataSharing planned: Undecided
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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.
Gianfranco Silecchia, MD PhD principal investigator
University of Roma La Sapienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini Gastric Bypass and Roux en Y Gastric Bypass in people with Obesity (Disorder), run by University of Roma La Sapienza at 1 site in Italy.
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 13 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 2021. 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 Italy. 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?
Gut Microbiota (time frame: 0-6-12 Months). 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 NCT03412149, which also lists 19 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 2021.