Multi Organ FailureNCT05710315
Evaluating the Utility of RELiZORB™ for Treating Feeding Intolerance in Critically Ill Adults With Multi-Organ Failure
A study testing RELiZORB™ in people with Multi Organ Failure and Exocrine Pancreatic Insufficiency, run by Inova Health Care Services at 1 site in United States.
Trial summary
The purpose of this research is to determine if the use of RELiZORB™ improves nutrition tolerance and helps critically ill patients meet their nutrition goals. RELiZORB™ is a digestive enzyme cartridge that contains lipase and works as a pancreatic enzyme replacement. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Multi Organ Failure, Exocrine Pancreatic Insufficiency
- What is being tested?
- RELiZORB™
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 18 - 89 years of age.
- Patients who have Multi-Organ Failure (MOF) (defined as requiring mechanical ventilation and demonstrating at least one more system failure on the SOFA score on the day of ICU admission).
- Patients who have not yet been initiated on enteral nutrition, yet enteral nutritional support is needed, or patients who have been initiated on enteral nutrition within the previous 48 hours. Enteral nutrition support defined as support planned to be given via any route connected to the gastrointestinal system (i.e., the enteral route). This includes tube feeding using nasogastric, nasoduodenal, gastrostomy, jejunostomy tubes, or similar.
- Patients who lack the capacity to consent for themselves may be included upon receiving consent from their legally authorized representatives.
Who cannot join
- Pregnant women and prisoners.
- Hypotension is attributed to suspected or confirmed cardiogenic shock.
- Evidence of unresolved intestinal obstruction, ischemia, bleeding, perforation, fistulas or tract discontinuity, or other contraindication for enteral nutrition.
- Sepsis suspected or confirmed due to an abdominal source and enteral nutrition is contraindicated.
- C. Difficile or other gastrointestinal infection that may manifest with diarrhea.
- Use of pancreatic hormone stimulant or inhibitor (e.g. octreotide, pancreatic enzyme supplements) during or immediately prior to hospital admission.
- Any other reason that the treating or investigator team considers to be a contraindication to enteral nutrition.
Trial locations and contacts
1 site in 1 country.
United States1 site
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042
About this study
Official title: Single-center, Proof of Concept, Prospective Study Evaluating the Utility of RELiZORB™ for the Treatment of Feeding Intolerance in Critically Ill Adults With Multi-Organ Failure
The purpose of this research is to determine if the use of RELiZORB™ improves nutrition tolerance and helps critically ill patients meet their nutrition goals. RELiZORB™ is a digestive enzyme cartridge that contains lipase and works as a pancreatic enzyme replacement. It promotes breaking down fat and helps the body absorb it. The device connects with tube feedings to help the body with digestion.
RELiZORB™ is approved by the U.S. Food and Drug Administration (FDA) for use with tube feedings in patients 5 years of age or older. While the use of RELiZORB™ in this study is consistent with the FDA approval, the use of RELiZORB™ in patients with multi organ failure is not in the current standard of care practice at Inova Health Care facilities.
Read the detailed description
This is a double-blind, placebo-controlled, parallel design study. A total of 32 adult patients who have been admitted to the Surgical or Medical Intensive Care Unit with evidence of MOF (defined as requiring mechanical ventilation and demonstrating at least one more system failure on the SOFA score on the day of ICU admission) and who have not yet been initiated on enteral nutrition or were initiated on enteral nutrition up to 48 hours prior.
After informed consent has been obtained, two patients will receive enteral formula administered through RELiZORB™ as test subjects (will be excluded from analysis). Subsequently, patients will be randomized to RELiZORB™ vs placebo cartridges in a 1:1 ratio. Enteral nutrition will be administered through RELiZORB™ cartridges (up to 6 cartridges per day depending on the volume of enteral nutrition). Patients will be studied for a total of 5 days (considered to be the end of study). Patients will return to the original form of nutritional support per their routine clinical care.
- Being tested
- RELiZORB™, Placebo
- Keywords
- Multi Organ Failure
- Medical subject headings
- Multiple Organ Failure, Exocrine Pancreatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RELiZORB™Device
RELiZORB cartridges will be used with routine enteral feedings for 5 days for randomized participants
PlaceboOther
Placebo cartridges will be used with routine enteral feedings for 5 days for randomized participants
| Study group | Role | What they receive |
|---|---|---|
| RELiZORB | Experimental | RELiZORB™ cartridges connect in-line with existing enteral feeding pump tubing sets and patient extension sets or enteral feeding tubes. Receives: Device: RELiZORB™ |
| Placebo | Placebo comparator | Placebo cartridges connect in-line with existing enteral feeding pump tubing sets and patient extension sets or enteral feeding tubes Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of RELiZORB™ in Enteral Nutrition Tolerance in Critically Ill Adults with Multiple Organ Failure Over Five Days
Efficacy will be assessed by the total calories administered, expressed as the percentage of goal nutrition calories achieved daily, compared between the two groups over the five-day study period
Measured: Duration of intervention (5 days)
Secondary outcomes (3)
Number of intolerance-related enteral nutrition pauses
The number of unplanned enteral nutrition pauses due to enteral nutrition intolerance
Measured: Duration of intervention (5 days)
Insulin units used
Insulin units used
Measured: Duration of intervention (5 days)
Change in fecal elastase
Change in fecal elastase as a measure of clinical exocrine pancreatic insufficiency
Measured: From Baseline to end of intervention at 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start7 May 2025
- Primary completion3 May 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Multi Organ FailureStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two patients will receive enteral formula administered through RELiZORB™ as test subjects (will be excluded from analysis). Subsequently, patients will be randomized to RELiZORB™ vs placebo cartridges in a 1:1 ratio. Enteral nutrition will be administered through RELiZORB™ cartridges (up to 6 cartridges per day depending on the volume of enteral nutrition). Patients will be studied for a total of 5 days (considered to be the end of study). Patients will return to the original form of nutritional support per their routine clinical care.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Collaborators
- Alcresta Therapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- George Kasotakis, MD MPH, Principal investigator, Inova Fairfax Medical Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710315
- Sponsor's protocol ID
- INOVA-2023-42
- Status last verified
- Oct 2026
- First submitted
- 24 Jan 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Charlson M, Szatrowski TP, Peterson J, Gold J. Validation of a combined comorbidity index. J Clin Epidemiol. 1994 Nov;47(11):1245-51. doi: 10.1016/0895-4356(94)90129-5.
PubMed 7722560Singer P, Blaser AR, Berger MM, Alhazzani W, Calder PC, Casaer MP, Hiesmayr M, Mayer K, Montejo JC, Pichard C, Preiser JC, van Zanten ARH, Oczkowski S, Szczeklik W, Bischoff SC. ESPEN guideline on clinical nutrition in the intensive care unit. Clin Nutr. 2019 Feb;38(1):48-79. doi: 10.1016/j.clnu.2018.08.037. Epub 2018 Sep 29.
PubMed 30348463Stevens J, Wyatt C, Brown P, Patel D, Grujic D, Freedman SD. Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study in Patients With Cystic Fibrosis Receiving Enteral Feeding. J Pediatr Gastroenterol Nutr. 2018 Oct;67(4):527-532. doi: 10.1097/MPG.0000000000002110.
PubMed 30074573Freedman S, Orenstein D, Black P, Brown P, McCoy K, Stevens J, Grujic D, Clayton R. Increased Fat Absorption From Enteral Formula Through an In-line Digestive Cartridge in Patients With Cystic Fibrosis. J Pediatr Gastroenterol Nutr. 2017 Jul;65(1):97-101. doi: 10.1097/MPG.0000000000001617.
PubMed 28471913van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.
PubMed 11794168Wang S, Ma L, Zhuang Y, Jiang B, Zhang X. Screening and risk factors of exocrine pancreatic insufficiency in critically ill adult patients receiving enteral nutrition. Crit Care. 2013 Aug 7;17(4):R171. doi: 10.1186/cc12850.
PubMed 23924602Saberi F, Heyland D, Lam M, Rapson D, Jeejeebhoy K. Prevalence, incidence, and clinical resolution of insulin resistance in critically ill patients: an observational study. JPEN J Parenter Enteral Nutr. 2008 May-Jun;32(3):227-35. doi: 10.1177/0148607108316195.
PubMed 18443133Nordenstrom J, Carpentier YA, Askanazi J, Robin AP, Elwyn DH, Hensle TW, Kinney JM. Free fatty acid mobilization and oxidation during total parenteral nutrition in trauma and infection. Ann Surg. 1983 Dec;198(6):725-35. doi: 10.1097/00000658-198312000-00011.
PubMed 6416194Kutsogiannis J, Alberda C, Gramlich L, Cahill NE, Wang M, Day AG, Dhaliwal R, Heyland DK. Early use of supplemental parenteral nutrition in critically ill patients: results of an international multicenter observational study. Crit Care Med. 2011 Dec;39(12):2691-9. doi: 10.1097/CCM.0b013e3182282a83.
PubMed 21765355Kelly MK. Bedside caregivers as change agents: implementation of early enteral nutrition in critical care. Crit Care Nurs Clin North Am. 2014 Jun;26(2):263-75. doi: 10.1016/j.ccell.2014.02.001.
PubMed 24878211Jarden RJ, Sutton LJ. A practice change initiative to improve the provision of enteral nutrition to intensive care patients. Nurs Crit Care. 2015 Sep;20(5):242-55. doi: 10.1111/nicc.12107. Epub 2014 Jul 18.
PubMed 25040624Jordan EA, Moore SC. Enteral nutrition in critically ill adults: Literature review of protocols. Nurs Crit Care. 2020 Jan;25(1):24-30. doi: 10.1111/nicc.12475. Epub 2019 Oct 10.
PubMed 31602712Compton F, Bojarski C, Siegmund B, van der Giet M. Use of a nutrition support protocol to increase enteral nutrition delivery in critically ill patients. Am J Crit Care. 2014 Sep;23(5):396-403. doi: 10.4037/ajcc2014140.
PubMed 25179035Doig GS, Heighes PT, Simpson F, Sweetman EA, Davies AR. Early enteral nutrition, provided within 24 h of injury or intensive care unit admission, significantly reduces mortality in critically ill patients: a meta-analysis of randomised controlled trials. Intensive Care Med. 2009 Dec;35(12):2018-27. doi: 10.1007/s00134-009-1664-4. Epub 2009 Sep 24.
PubMed 19777207Marik PE, Zaloga GP. Early enteral nutrition in acutely ill patients: a systematic review. Crit Care Med. 2001 Dec;29(12):2264-70. doi: 10.1097/00003246-200112000-00005.
PubMed 11801821
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Proof of Concept, Prospective Study Evaluating the Utility of RELiZORB™ for the Treatment of Feeding Intolerance in Critically Ill Adults With Multi-Organ Failure
- ClinicalTrials.gov ID
- NCT05710315
- Acronym / sponsor ID
- INOVA-2023-42
- Keywords
- Multi Organ Failure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Collaborators
- Alcresta Therapeutics, Inc.
- Study start
- 7 May 2025 (actual)
- Primary completion
- 3 May 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Feb 2023 (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 purpose of this research is to determine if the use of RELiZORB™ improves nutrition tolerance and helps critically ill patients meet their nutrition goals. RELiZORB™ is a digestive enzyme cartridge that contains lipase and works as a pancreatic enzyme replacement. It promotes breaking down fat and helps the body absorb it. The device connects with tube feedings to help the body with digestion.
RELiZORB™ is approved by the U.S. Food and Drug Administration (FDA) for use with tube feedings in patients 5 years of age or older. While the use of RELiZORB™ in this study is consistent with the FDA approval, the use of RELiZORB™ in patients with multi organ failure is not in the current standard of care practice at Inova Health Care facilities.
Detailed description
This is a double-blind, placebo-controlled, parallel design study. A total of 32 adult patients who have been admitted to the Surgical or Medical Intensive Care Unit with evidence of MOF (defined as requiring mechanical ventilation and demonstrating at least one more system failure on the SOFA score on the day of ICU admission) and who have not yet been initiated on enteral nutrition or were initiated on enteral nutrition up to 48 hours prior.
After informed consent has been obtained, two patients will receive enteral formula administered through RELiZORB™ as test subjects (will be excluded from analysis). Subsequently, patients will be randomized to RELiZORB™ vs placebo cartridges in a 1:1 ratio. Enteral nutrition will be administered through RELiZORB™ cartridges (up to 6 cartridges per day depending on the volume of enteral nutrition). Patients will be studied for a total of 5 days (considered to be the end of study). Patients will return to the original form of nutritional support per their routine clinical care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Two patients will receive enteral formula administered through RELiZORB™ as test subjects (will be excluded from analysis). Subsequently, patients will be randomized to RELiZORB™ vs placebo cartridges in a 1:1 ratio. Enteral nutrition will be administered through RELiZORB™ cartridges (up to 6 cartridges per day depending on the volume of enteral nutrition). Patients will be studied for a total of 5 days (considered to be the end of study). Patients will return to the original form of nutritional support per their routine clinical care.
| Arm | Type | Receives |
|---|---|---|
| RELiZORB | Experimental | Device: RELiZORB™RELiZORB™ cartridges connect in-line with existing enteral feeding pump tubing sets and patient extension sets or enteral feeding tubes. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo cartridges connect in-line with existing enteral feeding pump tubing sets and patient extension sets or enteral feeding tubes |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients aged 18 - 89 years of age.
- Patients who have Multi-Organ Failure (MOF) (defined as requiring mechanical ventilation and demonstrating at least one more system failure on the SOFA score on the day of ICU admission).
- Patients who have not yet been initiated on enteral nutrition, yet enteral nutritional support is needed, or patients who have been initiated on enteral nutrition within the previous 48 hours. Enteral nutrition support defined as support planned to be given via any route connected to the gastrointestinal system (i.e., the enteral route). This includes tube feeding using nasogastric, nasoduodenal, gastrostomy, jejunostomy tubes, or similar.
- Patients who lack the capacity to consent for themselves may be included upon receiving consent from their legally authorized representatives.
Key exclusion criteria (7 listed)
- Pregnant women and prisoners.
- Hypotension is attributed to suspected or confirmed cardiogenic shock.
- Evidence of unresolved intestinal obstruction, ischemia, bleeding, perforation, fistulas or tract discontinuity, or other contraindication for enteral nutrition.
- Sepsis suspected or confirmed due to an abdominal source and enteral nutrition is contraindicated.
- C. Difficile or other gastrointestinal infection that may manifest with diarrhea.
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 |
|---|---|---|
| RELiZORB™RELiZORB cartridges will be used with routine enteral feedings for 5 days for randomized participants | Device | RELiZORB |
| PlaceboPlacebo cartridges will be used with routine enteral feedings for 5 days for randomized participants | Other | Placebo |
Primary outcome
Efficacy of RELiZORB™ in Enteral Nutrition Tolerance in Critically Ill Adults with Multiple Organ Failure Over Five Days
Time frame: Duration of intervention (5 days)
Efficacy will be assessed by the total calories administered, expressed as the percentage of goal nutrition calories achieved daily, compared between the two groups over the five-day study period
3 secondary outcomes
Number of intolerance-related enteral nutrition pauses
Time frame: Duration of intervention (5 days)
Insulin units used
Time frame: Duration of intervention (5 days)
Change in fecal elastase
Time frame: From Baseline to end of intervention at 5 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 7722560Charlson M, Szatrowski TP, Peterson J, Gold J. Validation of a combined comorbidity index. J Clin Epidemiol. 1994 Nov;47(11):1245-51. doi: 10.1016/0895-4356(94)90129-5.
- Background: PubMed 30348463Singer P, Blaser AR, Berger MM, Alhazzani W, Calder PC, Casaer MP, Hiesmayr M, Mayer K, Montejo JC, Pichard C, Preiser JC, van Zanten ARH, Oczkowski S, Szczeklik W, Bischoff SC. ESPEN guideline on clinical nutrition in the intensive care unit. Clin Nutr. 2019 Feb;38(1):48-79. doi: 10.1016/j.clnu.2018.08.037. Epub 2018 Sep 29.
- Background: PubMed 30074573Stevens J, Wyatt C, Brown P, Patel D, Grujic D, Freedman SD. Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study in Patients With Cystic Fibrosis Receiving Enteral Feeding. J Pediatr Gastroenterol Nutr. 2018 Oct;67(4):527-532. doi: 10.1097/MPG.0000000000002110.
- Background: PubMed 28471913Freedman S, Orenstein D, Black P, Brown P, McCoy K, Stevens J, Grujic D, Clayton R. Increased Fat Absorption From Enteral Formula Through an In-line Digestive Cartridge in Patients With Cystic Fibrosis. J Pediatr Gastroenterol Nutr. 2017 Jul;65(1):97-101. doi: 10.1097/MPG.0000000000001617.
- Background: PubMed 11794168van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.
- Background: PubMed 23924602Wang S, Ma L, Zhuang Y, Jiang B, Zhang X. Screening and risk factors of exocrine pancreatic insufficiency in critically ill adult patients receiving enteral nutrition. Crit Care. 2013 Aug 7;17(4):R171. doi: 10.1186/cc12850.
- Background: PubMed 18443133Saberi F, Heyland D, Lam M, Rapson D, Jeejeebhoy K. Prevalence, incidence, and clinical resolution of insulin resistance in critically ill patients: an observational study. JPEN J Parenter Enteral Nutr. 2008 May-Jun;32(3):227-35. doi: 10.1177/0148607108316195.
- Background: PubMed 6416194Nordenstrom J, Carpentier YA, Askanazi J, Robin AP, Elwyn DH, Hensle TW, Kinney JM. Free fatty acid mobilization and oxidation during total parenteral nutrition in trauma and infection. Ann Surg. 1983 Dec;198(6):725-35. doi: 10.1097/00000658-198312000-00011.
- Background: PubMed 21765355Kutsogiannis J, Alberda C, Gramlich L, Cahill NE, Wang M, Day AG, Dhaliwal R, Heyland DK. Early use of supplemental parenteral nutrition in critically ill patients: results of an international multicenter observational study. Crit Care Med. 2011 Dec;39(12):2691-9. doi: 10.1097/CCM.0b013e3182282a83.
- Background: PubMed 24878211Kelly MK. Bedside caregivers as change agents: implementation of early enteral nutrition in critical care. Crit Care Nurs Clin North Am. 2014 Jun;26(2):263-75. doi: 10.1016/j.ccell.2014.02.001.
- Background: PubMed 25040624Jarden RJ, Sutton LJ. A practice change initiative to improve the provision of enteral nutrition to intensive care patients. Nurs Crit Care. 2015 Sep;20(5):242-55. doi: 10.1111/nicc.12107. Epub 2014 Jul 18.
- Background: PubMed 31602712Jordan EA, Moore SC. Enteral nutrition in critically ill adults: Literature review of protocols. Nurs Crit Care. 2020 Jan;25(1):24-30. doi: 10.1111/nicc.12475. Epub 2019 Oct 10.
- 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.
George Kasotakis, MD MPH principal investigator
Inova Fairfax Medical Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RELiZORB™ in people with Multi Organ Failure and Exocrine Pancreatic Insufficiency, run by Inova Health Care Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Efficacy of RELiZORB™ in Enteral Nutrition Tolerance in Critically Ill Adults with Multiple Organ Failure Over Five Days (time frame: Duration of intervention (5 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 NCT05710315, which also lists 21 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 13 Oct 2026.