ColonoscopyNCT05637021
Effect of Carbon Dioxide Insufflation and Appendix on the Restoration of Intestinal Microecology After Colonoscopy.
An observational study of Colonoscopy and Gastrointestinal Microbiome, run by Zhongshan Hospital Xiamen University at 1 site in China.
Trial summary
The goal of this observational study is to learn about Influencing factors of intestinal microecological changes before and after colonoscopy. The main questions it aims to answer are: [question 1] The process of colonoscopic gas insufflation affects the intestinal microecology. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy, Gastrointestinal Microbiome, Appendix
- What is being tested?
- Carbon dioxide insufflated during colonoscopy
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2022to 31 Dec 2022
- Phase
- Observational
- 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
Study population: The patients in the after appendectomy group were patients who underwent appendectomy in the Department of General Surgery, Zhongshan Hospital Xiamen University within 3 years. The other volunteers are residents of Xiamen City.
Who may be able to join
- Age 18-40 years old, gender is not limited, no underlying diseases;
- BMI between 18.5-23.9 kg/m2;
- Fecal Bristol score type III-IV in the past week;
- No history of alcohol consumption or alcohol consumption equivalent to ethanol should not exceed 140g per week for men and 70g per week for women.
- Add a criterion to after appendectomy group:Patients who underwent appendectomy in the Department of General Surgery of Zhongshan Hospital Xiamen University within 3 years.
Who cannot join
- Those who use antibiotics, antifungal drugs, antiviral drugs, probiotics, prebiotics, synbiotics and drugs that may affect the intestinal microecology within 1 month;
- Those who have acute enteritis or chronic enteritis and other diagnosed chronic bowel diseases in the past 1 month;
- Those who have digestive symptoms such as blood in the stool, constipation, bloating, abdominal pain, diarrhea and so on in the past 1 month
- History of digestive surgery (including gastrointestinal polyp resection, gastrointestinal tumor surgery and diversion surgery, etc.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Influencing Factors of Intestinal Microecology Changes Before and After Colonoscopy
The goal of this observational study is to learn about Influencing factors of intestinal microecological changes before and after colonoscopy. The main questions it aims to answer are:
- [question 1] The process of colonoscopic gas insufflation affects the intestinal microecology. Will the use of carbon dioxide gas insufflation can reduce the changes of intestinal microecology after colonoscopy?
- [question 2] Can the appendix act as a reservoir for microorganisms to accelerate the recovery of intestinal microecology after colonoscopy?
Read more
Participants will be asked to accept colonoscopy for once. Group 1(Control group) will be insufflated air during the colonoscopy; Group 2(Carbon dioxide group) will be insufflated carbon dioxide during the colonoscopy; Group 3(After appendectomy group) will be insufflated air during the colonoscopy.
Since Group 1 is comparison group, the investigators will compare Group 2 to see if carbon dioxide gas insufflation can reduce the changes of intestinal microecology after colonoscopy. Meanwhile, compare Group 3 to see if the appendix can accelerate the recovery of intestinal microecology after colonoscopy.
Read the detailed description
Usually, gastroenteroscopy requires gas insufflation to expand the lumen to facilitate endoscopic insertion and detailed observation of the mucosa. In the past, the use of air as an insufflation gas in endoscopic operations was simple and inexpensive, but because its main component was nitrogen, it was difficult to be absorbed by the gastrointestinal mucosa. Therefore, the endoscopist often needs to fully aspirate the gas when the procedure is completed. However, studies have shown that about 50% of patients still complain of abdominal pain after colonoscopy, and 12% of patients still have severe abdominal pain even after 24 hours. In contrast, carbon dioxide (CO2) has been used in endoscopy of the digestive tract in recent years because it can be rapidly absorbed by the gastrointestinal mucosa, and has attracted the attention of endoscopists.
The gastrointestinal mucosa absorbs CO2 at a rate 160 times faster than nitrogen. Because of this property, many people consider replacing air in endoscopic operations. Its potential value was first demonstrated in animal tests: the recovery time of intestinal lumen dilation and increased intraluminal pressure was significantly shortened after intestinal lumen injection of CO2 in rats. Meta-analysis showed no significant difference in safety, gas volume, or cecal intubation rate between the two groups for CO2 insufflation during colonoscopy, but less postoperative abdominal pain, abdominal distention, and less postoperative gastrointestinal exhaust in the CO2 group. The low postoperative pain score and low increase in abdominal circumference may be due to the rapid absorption of CO2 by the gastrointestinal mucosa, suggesting that residual gas after colonoscopy is the main cause of abdominal pain. CO2 is a non-flammable gas that is safe for electroresection and has been widely used in laparoscopic surgery. For patients with chronic obstructive pulmonary disease (COPD) who require endoscopy, it is worth exploring whether the use of CO2 in endoscopy causes CO2 retention. In one study of 77 endoscopic participants with obstructive ventilation dysfunction and 308 endoscopic participants without concomitant obstructive ventilation dysfunction, there was no difference in end-tidal volume CO2 between the two groups, and the peak tidal volume CO2 peak was less than 60 mmHg in both groups, suggesting that endoscopic use of CO2 is still safe for people with concomitant obstructive ventilation dysfunction.
The current study has found that the intestinal preparation of the colonoscopy, as well as the colonoscopy operation itself, has a certain impact on the intestinal microbiome, although this effect can be partially recovered over a period of time, but the current study has found that this change may also be permanent, but whether it will cause long-term metabolic, immune or clinical changes in the host is unknown. Compared with conventional air injection, CO2 may change less about the hypoxic environment of the intestine, thereby reducing the impact on the normal intestinal microbiome.
Based on this hypothesis, the investigators will conduct randomized, controlled experiments to investigate the effects of conventional air and CO2 insufflation on the intestinal microbiome and metabolites.
In addition, some studies have called the appendix a "reservoir" of gut microbes. First, the mucosal flora of the appendix is similar to the rest of the colon; Secondly, the fecal microbiota composition of mice changed after appendectomy. The appendix preserves a small amount of intestinal bacteria as "seeds", once the intestinal flora is imbalanced, the "seed bank" will be used for cultivation, when the appendix is removed, it is equivalent to the "seed bank" is destroyed, so once the intestinal flora is imbalanced, there may be a delay in the recovery of the intestinal microecology.
Based on this hypothesis, the investigators will conduct controlled experiments to compare the intestinal microbiome recovery after colonoscopy in healthy people and people after appendectomy, and explore the impact of appendix on intestinal microbiome recovery.
This study was a single-center study, and 20 cases were initially included in the control group, CO2 group and after appendectomy group.
- Being tested
- Carbon dioxide insufflated during colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon dioxide insufflated during colonoscopyOther
Carbon dioxide is insufflated to dilate the bowel lumen during colonoscopy.Record the amount of gas insufflated during colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Healthy people were randomly divided into CO2 group and control group, with 20 cases in each group. After bowel preparation, volunteers underwent colonoscopy, with air routinely insufflated into the control group during colonoscopy. | |
| Carbon dioxide group | Healthy people were randomly divided into CO2 group and control group, with 20 cases in each group. After bowel preparation, volunteers underwent colonoscopy, with CO2 insufflated into the control group during colonoscopy. Receives: Other: Carbon dioxide insufflated during colonoscopy | |
| After appendectomy group | Volunteers after appendectomy were included in the appendectomy group. After bowel preparation, all volunteers underwent colonoscopy, air routinely insufflated into the appendectomy group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The intestinal microbiota composition
Changes in the intestinal microbiome are observed by detecting the feces at the specific time point.Then, factors affecting the recovery of the intestinal microbiome are assessed based on their changes.
Measured: Before bowel cleansing, after colonoscopy, 7、14 and 28 days after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start1 Feb 2022
- Primary completion14 Jul 2022
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongshan Hospital Xiamen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongzhi Xu, Principal investigator, Zhongshan Hospital Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637021
- Sponsor's protocol ID
- 2022-014
- Status last verified
- Dec 2022
- First submitted
- 24 Nov 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Publications
Wu J, Hu B. The role of carbon dioxide insufflation in colonoscopy: a systematic review and meta-analysis. Endoscopy. 2012 Feb;44(2):128-36. doi: 10.1055/s-0031-1291487. Epub 2012 Jan 23.
PubMed 22271023Eckburg PB, Bik EM, Bernstein CN, Purdom E, Dethlefsen L, Sargent M, Gill SR, Nelson KE, Relman DA. Diversity of the human intestinal microbial flora. Science. 2005 Jun 10;308(5728):1635-8. doi: 10.1126/science.1110591. Epub 2005 Apr 14.
PubMed 15831718Masahata K, Umemoto E, Kayama H, Kotani M, Nakamura S, Kurakawa T, Kikuta J, Gotoh K, Motooka D, Sato S, Higuchi T, Baba Y, Kurosaki T, Kinoshita M, Shimada Y, Kimura T, Okumura R, Takeda A, Tajima M, Yoshie O, Fukuzawa M, Kiyono H, Fagarasan S, Iida T, Ishii M, Takeda K. Generation of colonic IgA-secreting cells in the caecal patch. Nat Commun. 2014 Apr 10;5:3704. doi: 10.1038/ncomms4704.
PubMed 24718324Jalanka J, Salonen A, Salojarvi J, Ritari J, Immonen O, Marciani L, Gowland P, Hoad C, Garsed K, Lam C, Palva A, Spiller RC, de Vos WM. Effects of bowel cleansing on the intestinal microbiota. Gut. 2015 Oct;64(10):1562-8. doi: 10.1136/gutjnl-2014-307240. Epub 2014 Dec 19.
PubMed 25527456Drago L, Toscano M, De Grandi R, Casini V, Pace F. Persisting changes of intestinal microbiota after bowel lavage and colonoscopy. Eur J Gastroenterol Hepatol. 2016 May;28(5):532-7. doi: 10.1097/MEG.0000000000000581.
PubMed 27015015Nagata N, Tohya M, Fukuda S, Suda W, Nishijima S, Takeuchi F, Ohsugi M, Tsujimoto T, Nakamura T, Shimomura A, Yanagisawa N, Hisada Y, Watanabe K, Imbe K, Akiyama J, Mizokami M, Miyoshi-Akiyama T, Uemura N, Hattori M. Effects of bowel preparation on the human gut microbiome and metabolome. Sci Rep. 2019 Mar 11;9(1):4042. doi: 10.1038/s41598-019-40182-9.
PubMed 30858400
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Influencing Factors of Intestinal Microecology Changes Before and After Colonoscopy
- ClinicalTrials.gov ID
- NCT05637021
- Acronym / sponsor ID
- 2022-014
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Zhongshan Hospital Xiamen UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 14 Jul 2022 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about Influencing factors of intestinal microecological changes before and after colonoscopy. The main questions it aims to answer are:
- [question 1] The process of colonoscopic gas insufflation affects the intestinal microecology. Will the use of carbon dioxide gas insufflation can reduce the changes of intestinal microecology after colonoscopy?
- [question 2] Can the appendix act as a reservoir for microorganisms to accelerate the recovery of intestinal microecology after colonoscopy?
Participants will be asked to accept colonoscopy for once. Group 1(Control group) will be insufflated air during the colonoscopy; Group 2(Carbon dioxide group) will be insufflated carbon dioxide during the colonoscopy; Group 3(After appendectomy group) will be insufflated air during the colonoscopy.
Since Group 1 is comparison group, the investigators will compare Group 2 to see if carbon dioxide gas insufflation can reduce the changes of intestinal microecology after colonoscopy. Meanwhile, compare Group 3 to see if the appendix can accelerate the recovery of intestinal microecology after colonoscopy.
Detailed description
Usually, gastroenteroscopy requires gas insufflation to expand the lumen to facilitate endoscopic insertion and detailed observation of the mucosa. In the past, the use of air as an insufflation gas in endoscopic operations was simple and inexpensive, but because its main component was nitrogen, it was difficult to be absorbed by the gastrointestinal mucosa. Therefore, the endoscopist often needs to fully aspirate the gas when the procedure is completed. However, studies have shown that about 50% of patients still complain of abdominal pain after colonoscopy, and 12% of patients still have severe abdominal pain even after 24 hours. In contrast, carbon dioxide (CO2) has been used in endoscopy of the digestive tract in recent years because it can be rapidly absorbed by the gastrointestinal mucosa, and has attracted the attention of endoscopists.
The gastrointestinal mucosa absorbs CO2 at a rate 160 times faster than nitrogen. Because of this property, many people consider replacing air in endoscopic operations. Its potential value was first demonstrated in animal tests: the recovery time of intestinal lumen dilation and increased intraluminal pressure was significantly shortened after intestinal lumen injection of CO2 in rats. Meta-analysis showed no significant difference in safety, gas volume, or cecal intubation rate between the two groups for CO2 insufflation during colonoscopy, but less postoperative abdominal pain, abdominal distention, and less postoperative gastrointestinal exhaust in the CO2 group. The low postoperative pain score and low increase in abdominal circumference may be due to the rapid absorption of CO2 by the gastrointestinal mucosa, suggesting that residual gas after colonoscopy is the main cause of abdominal pain. CO2 is a non-flammable gas that is safe for electroresection and has been widely used in laparoscopic surgery. For patients with chronic obstructive pulmonary disease (COPD) who require endoscopy, it is worth exploring whether the use of CO2 in endoscopy causes CO2 retention. In one study of 77 endoscopic participants with obstructive ventilation dysfunction and 308 endoscopic participants without concomitant obstructive ventilation dysfunction, there was no difference in end-tidal volume CO2 between the two groups, and the peak tidal volume CO2 peak was less than 60 mmHg in both groups, suggesting that endoscopic use of CO2 is still safe for people with concomitant obstructive ventilation dysfunction.
The current study has found that the intestinal preparation of the colonoscopy, as well as the colonoscopy operation itself, has a certain impact on the intestinal microbiome, although this effect can be partially recovered over a period of time, but the current study has found that this change may also be permanent, but whether it will cause long-term metabolic, immune or clinical changes in the host is unknown. Compared with conventional air injection, CO2 may change less about the hypoxic environment of the intestine, thereby reducing the impact on the normal intestinal microbiome.
Based on this hypothesis, the investigators will conduct randomized, controlled experiments to investigate the effects of conventional air and CO2 insufflation on the intestinal microbiome and metabolites.
In addition, some studies have called the appendix a "reservoir" of gut microbes. First, the mucosal flora of the appendix is similar to the rest of the colon; Secondly, the fecal microbiota composition of mice changed after appendectomy. The appendix preserves a small amount of intestinal bacteria as "seeds", once the intestinal flora is imbalanced, the "seed bank" will be used for cultivation, when the appendix is removed, it is equivalent to the "seed bank" is destroyed, so once the intestinal flora is imbalanced, there may be a delay in the recovery of the intestinal microecology.
Based on this hypothesis, the investigators will conduct controlled experiments to compare the intestinal microbiome recovery after colonoscopy in healthy people and people after appendectomy, and explore the impact of appendix on intestinal microbiome recovery.
This study was a single-center study, and 20 cases were initially included in the control group, CO2 group and after appendectomy group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –Healthy people were randomly divided into CO2 group and control group, with 20 cases in each group. After bowel preparation, volunteers underwent colonoscopy, with air routinely insufflated into the control group during colonoscopy. |
| Carbon dioxide group | – | Other: Carbon dioxide insufflated during colonoscopyHealthy people were randomly divided into CO2 group and control group, with 20 cases in each group. After bowel preparation, volunteers underwent colonoscopy, with CO2 insufflated into the control group during colonoscopy. |
| After appendectomy group | – | –Volunteers after appendectomy were included in the appendectomy group. After bowel preparation, all volunteers underwent colonoscopy, air routinely insufflated into the appendectomy group. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The patients in the after appendectomy group were patients who underwent appendectomy in the Department of General Surgery, Zhongshan Hospital Xiamen University within 3 years. The other volunteers are residents of Xiamen City.
Key inclusion criteria (5 listed)
- Age 18-40 years old, gender is not limited, no underlying diseases;
- BMI between 18.5-23.9 kg/m2;
- Fecal Bristol score type III-IV in the past week;
- No history of alcohol consumption or alcohol consumption equivalent to ethanol should not exceed 140g per week for men and 70g per week for women.
- Add a criterion to after appendectomy group:Patients who underwent appendectomy in the Department of General Surgery of Zhongshan Hospital Xiamen University within 3 years.
Key exclusion criteria (4 listed)
- Those who use antibiotics, antifungal drugs, antiviral drugs, probiotics, prebiotics, synbiotics and drugs that may affect the intestinal microecology within 1 month;
- Those who have acute enteritis or chronic enteritis and other diagnosed chronic bowel diseases in the past 1 month;
- Those who have digestive symptoms such as blood in the stool, constipation, bloating, abdominal pain, diarrhea and so on in the past 1 month
- History of digestive surgery (including gastrointestinal polyp resection, gastrointestinal tumor surgery and diversion surgery, etc.).
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 |
|---|---|---|
| Carbon dioxide insufflated during colonoscopyCarbon dioxide is insufflated to dilate the bowel lumen during colonoscopy.Record the amount of gas insufflated during colonoscopy. | Other | Carbon dioxide group |
Primary outcome
The intestinal microbiota composition
Time frame: Before bowel cleansing, after colonoscopy, 7、14 and 28 days after the treatment
Changes in the intestinal microbiome are observed by detecting the feces at the specific time point.Then, factors affecting the recovery of the intestinal microbiome are assessed based on their changes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Background: PubMed 22271023Wu J, Hu B. The role of carbon dioxide insufflation in colonoscopy: a systematic review and meta-analysis. Endoscopy. 2012 Feb;44(2):128-36. doi: 10.1055/s-0031-1291487. Epub 2012 Jan 23.
- Background: PubMed 15831718Eckburg PB, Bik EM, Bernstein CN, Purdom E, Dethlefsen L, Sargent M, Gill SR, Nelson KE, Relman DA. Diversity of the human intestinal microbial flora. Science. 2005 Jun 10;308(5728):1635-8. doi: 10.1126/science.1110591. Epub 2005 Apr 14.
- Background: PubMed 24718324Masahata K, Umemoto E, Kayama H, Kotani M, Nakamura S, Kurakawa T, Kikuta J, Gotoh K, Motooka D, Sato S, Higuchi T, Baba Y, Kurosaki T, Kinoshita M, Shimada Y, Kimura T, Okumura R, Takeda A, Tajima M, Yoshie O, Fukuzawa M, Kiyono H, Fagarasan S, Iida T, Ishii M, Takeda K. Generation of colonic IgA-secreting cells in the caecal patch. Nat Commun. 2014 Apr 10;5:3704. doi: 10.1038/ncomms4704.
- Results publication: PubMed 25527456Jalanka J, Salonen A, Salojarvi J, Ritari J, Immonen O, Marciani L, Gowland P, Hoad C, Garsed K, Lam C, Palva A, Spiller RC, de Vos WM. Effects of bowel cleansing on the intestinal microbiota. Gut. 2015 Oct;64(10):1562-8. doi: 10.1136/gutjnl-2014-307240. Epub 2014 Dec 19.
- Results publication: PubMed 27015015Drago L, Toscano M, De Grandi R, Casini V, Pace F. Persisting changes of intestinal microbiota after bowel lavage and colonoscopy. Eur J Gastroenterol Hepatol. 2016 May;28(5):532-7. doi: 10.1097/MEG.0000000000000581.
- Results publication: PubMed 30858400Nagata N, Tohya M, Fukuda S, Suda W, Nishijima S, Takeuchi F, Ohsugi M, Tsujimoto T, Nakamura T, Shimomura A, Yanagisawa N, Hisada Y, Watanabe K, Imbe K, Akiyama J, Mizokami M, Miyoshi-Akiyama T, Uemura N, Hattori M. Effects of bowel preparation on the human gut microbiome and metabolome. Sci Rep. 2019 Mar 11;9(1):4042. doi: 10.1038/s41598-019-40182-9.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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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.
Hongzhi Xu principal investigator
Zhongshan Hospital Xiamen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonoscopy and Gastrointestinal Microbiome, run by Zhongshan Hospital Xiamen University at 1 site in China.
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 4 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: status not confirmed, as of the sponsor's last update on 9 Dec 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 China. 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?
Results are not available in the source record.
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?
The intestinal microbiota composition (time frame: Before bowel cleansing, after colonoscopy, 7、14 and 28 days after the treatment). 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 NCT05637021, which also lists 6 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 9 Dec 2022.