HealthyFRESHNCT03440229
Functional Research of Emulsifiers in Humans
A study testing Emulsifier-containing diet in people with Healthy, run by University of Pennsylvania at 1 site in United States.
Trial summary
A randomized double-blind study of the effect of carboxymethylcellulose (CMC) on stool microbiota composition, microbiota localization, and metabolic parameters in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Emulsifier-containing diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2018to 13 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant is capable of giving informed consent
- Participant is age 18 to 60 years
Who cannot join
- Diagnosis with Inflammatory Bowel Disease (IBD), celiac disease, or other chronic intestinal disorders. Since we are interested in assessing the impact of diet on the microbiome in the absence of pathologic inflammation, we will exclude participants with chronic intestinal abnormalities.
- Baseline bowel frequency less than every 2 days or greater than 3 times daily. Normal bowel frequency is every 3rd day to 3 times per day.20-23 Although unknown, stool frequency could be related to the microbiome composition.24-26 Furthermore, change in diet could alter baseline stool frequency, potentially causing diarrhea, particularly in those with high baseline stool frequency, or severe constipation in those with low stool frequency. To avoid the need for use of antidiarrheal medications or laxatives, which themselves could alter the microbiome composition, these patients will be excluded.
- Current smoker. What effect smoking has on the microbiome of the gut is unknown. Furthermore, because our hospital is a smoke-free environment, volunteers will not be able to smoke. Thus, inclusion of smokers would increase the risk of early withdrawal from the study.
- Body Mass Index (BMI) <18.5 or >40 at screening. Volunteers with BMI below normal27 will be excluded to prevent inclusion of participants with a subclinical systemic disease that may influence the gut microbiome. Volunteers with severe obesity will be excluded as obesity may be associated with altered gut microbiome composition.
- More than two of the criteria for metabolic syndrome:
- A waist circumference greater than 35 inches (89 centimeters) for women and 40 inches (102 centimeters) for men at screening.
Show all 28Show fewer
- A diagnosis of diabetes mellitus or baseline HbA1c > 6.4% or a fasting glucose level of greater than 100mg/dL
- Systolic blood pressure >130 mmHg or diastolic blood pressure >85 mmHg or treated with medications for hypertension at screening.
- Fasting triglycerides >149 mg/dl or treated with medications for hypertriglyceridemia
- Fasting HDL cholesterol <40 mg/dl in men or <50 mg/dl in women or treated with medications for hypercholesterolemia
- Known substance abuse disorder or consumption of illicit drugs or alcohol in the 24 hours prior to admission to the Center for Human Phenomic Science (CHPS).
- Prior bowel resection surgery other than appendectomy. It is unknown how prior bowel resection surgery may influence the microbiome composition, hence we will exclude these participants.
- Contraindication to flexible sigmoidoscopy and biopsies. Patients with suppressed white blood count may be at increased risk of systemic infection following sigmoidoscopy with biopsies. As such, participants with a white blood cell (WBC) less than 3,500 or an absolute neutrophil count of less than 1,000 will be excluded. Patients with thrombocytopenia or with a coagulopathy may be at increased risk of bleeding complications after colonoscopic biopsies. As such, patients with a platelet count of less than 100,000 or an international normalized ratio (INR) greater than 1.2 will be excluded from the study.
- Estimated glomerular filtration rate (GFR)<60ml/min/1.73m2 based on measured serum creatinine concentration
- Pregnant and lactating women. To avoid any risk to an unborn fetus or new born baby from changing the mother's diet, pregnant and lactating women will be excluded.
- Use of antibiotics in the 6 months prior to Visit 2. A small proportion of bacteria may require 6 months to recover after treatment with antibiotics.28
- Use of antacids, NSAIDs, or dietary supplements in the week prior to Visit 2. NSAIDs have been associated with C. difficile colitis, although whether this is causative and whether this is mediated through changing the fecal microbiota composition is unknown.29 Antacids could potentially alter the gut microbiota by changing the acid milieu or by altering fecal transit time. For our study purposes, multivitamins will not be considered dietary supplements.
- Use of laxatives or anti-diarrhea medications in the two weeks prior to Visit 2.
- Use of anticholinergics in the week prior Visit 2.
- Use of narcotics in the week prior to Visit 2.
- HIV infection, AIDS, or other known conditions resulting in immunosuppression - we will determine this by direct participant query; no formal testing will be done.
- Allergies or intolerance to the components of the study diets.
- Participant has experienced diarrhea within the two weeks prior to Visit 2. Diarrhea is defined as a change in bowel habits with an increased frequency or loose stools such that the stool could not be lifted with a fork.
- Refusal to use a medically accepted method of birth control while participating in this study, such as a barrier method, hormonal contraceptives, implanted birth control devices, permanent methods (such as a vasectomy), and/or abstinence.
- Vegans and Vegetarians.
- Student or employee of any one of the investigators.
- Anyone who cannot receive study payment (ie: visa)
- Any condition that the investigator feels may limit the volunteer's ability to complete the study protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
A randomized double-blind study of the effect of carboxymethylcellulose (CMC) on stool microbiota composition, microbiota localization, and metabolic parameters in healthy subjects. It includes a 11-day in-patient stay, randomization to an emulsifier-free group or a CMC group with the same diet except baked goods/sorbet with added CMC at 15g/person/day.
Read the detailed description
This is a randomized double-blind, controlled feeding experiment examining the effect of CMC on the stool microbiota composition, gene expression, and microbiota localization with respect to the epithelium. In addition, the investigators will assess the impact of CMC exposure in the diet on markers of metabolic syndrome including response to oral glucose tolerance testing and other plasma metabolite measurements.
Sixteen healthy volunteers were be recruited. 3 were admitted for 17 days and 13 participants were admitted for an 11-day in-patient study. All participants received 3 full days of freshly prepared emulsifier-free food to begin the study. This will be called the "washout period". Those will a 17 day stay received the wash out diet while inpatient and those with an 11 day stay received the wash out dies while out patient. Participants will then be randomized into an "emulsifier-free" arm and a "CMC" arm in a 1:1 ratio. Both arms will continue the same diet except that the "CMC" arm's brownie and sorbet will have CMC added to achieve a level of 15 gm per person per day consumption. Serial collection of fecal, plasma, urine and mucosal biopsy samples will be performed to investigate the extent to which CMC consumption by humans impacts the gut microbiota and its interaction with the host parameters related to inflammation and metabolism. Participants will have daily urine and stool collections. Sigmoidoscopies and glucose tolerance testing will be completed on the day prior to the start of the intervention and the last day of the inpatient stay (Days 4 and 17 for the 3 participants with a 17 day stay and days 1 and 11 for participants with an 11 day stay. Blood samples were collected on days 1-4, 5, 8, 10, 12, 15, and 17 for those with a 17 day inpatient stay and 1-4, 8, 10, and 11 for those with an 11 day stay.
- Conditions
- Healthy
- Being tested
- Emulsifier-containing diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emulsifier-containing dietOther
Also called Carboxymethylcellulose (CMC)
CMC is one of many synthetic dietary emulsifiers that are incorporated into a variety of processed foods. We have recently shown that, in mice, consumption of P80 and CMC, alters microbiota composition, have pro-inflammatory potential and promote microbiota encroachment into the colonic mucosa, low-grade inflammation, and metabolic syndrome. However, it is not known whether these compounds have similar effects in humans. We would like to study these effects in the human gut microbiota.
| Study group | Role | What they receive |
|---|---|---|
| Emuslfier-free diet | No intervention | This is western style diet prepared without any emulsifiers. Emulsifier free brownies and sorbet are provided daily. |
| Emulsifier-containing diet | Experimental | This is a western style diet prepared without any emulsifiers with the exception of the CMC that is included in brownies and sorbet that are provided daily. Receives: Other: Emulsifier-containing diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance of Nearest Bacteria to the Epithelium
Measured distance from the epithelium to the nearest bacteria under high powered microscopy; The measurements were taken on the last day of the diet intervention. An average of 3 measurements was taken.
Measured: last day of inpatient stay (either day 17 for the 3 participants with a 17 day inpatient stay or day 11 for the 13 participants with an 11 day inpatient stay.)
Secondary outcomes (5)
Change in Weight
Comparison of weight change during the study period - pre and post intervention. Weight on the last day of the inpatient stay was substracted from weight after the washout period but before the start of the intervention.For 3 participants with a 17 day stay, weight from day 4 of the inpatient stay was substracted from day 17. For 13 with an 11 day stay, weight from Day 1 of the inpatient stay was substracted from Day 11
Measured: For 3 participants with a 17 day stay, weight was measured on Day 4 and Day 17 of the inpatient stay. For 13 participants with an 11 day stay, weight was measured on Day 1 and Day 11 of the inpatient stay.
Area Under Glucose Concentration Curve
Area under the glucose concentration curves during the oral glucose tolerance test. These measurements were obtained by subtracting the pre from the post net incremental area under the curve. For 3 participants with a 17 day stay, area under the glucose curve from day 4 of the inpatient stay was substracted from day 17. For 13 participants with an 11 day stay, area under the glucose curve from Day 1 of the inpatient stay was substracted from Day 11
Measured: For 3 participants with a 17 day stay, area under the glucose curve was measured on days 4 and 17 of the inpatient stay . For 13 participanst with an 11 day stay, area under the glucose curve was measured on days 1 and Day 11 of the inpatient stay.
Area Under Insulin Concentration Curve
Area under the insulin concentration curves during the oral glucose tolerance test. These measurements were obtained by subtracting the pre from the post net incremental area under the curve. This is measured in microliter international units/milliliter. For 3 participants with a 17 day stay, area under the insulin concentration curve from day 4 of the inpatient stay was substracted from day 17. For 13 participants with an 11 day stay, area under the insulin concentration curve from Day 1 of the inpatient stay was substracted from Day 11
Measured: For 3 pts. with 17 day stays, area under the curve was measured on days 4 and 17 of the inpatient stay. For 13 pts. with 11 day stays, area under the curve was measured on days 1 and Day 11 of the inpatient stay.
Visual Analog Scale Measurements - Satiety/Hunger - Change From Baseline
Desire to eat, hunger, fullness, and prospective food consumption were rated on a 150-mm visual analog scale (VAS) that was adapted from Hill and Blundell in Doucet et al.(see references) The Satiety questionnaire was given before a meal (preprandial) and after the meal (postprandial). The minimum score is 0mm and the maximum score is 150mm for each question. The score prior to the intervention was subtracted from the post intervention score measured on the last day of the inpatient stay. Each question is scored individually. Higher score means more of the characteristic being measured. There are no better or worse outcomes based on these scores.
Measured: Measured at end of inpatient stay (Day 17 for 3 participants and Day 11 for 13 participants) comparing it to the study start (prior to diet intervention; either day 4 for the 3 participants or day 1 for 13 participants.
Fecal Lipocalin-2
Fecal lipocalin-2 by Elisa
Measured: For the 3 participants with a 17 day inpatiet stay, this was measured on Day 17. For the 13 participants with an 11 day stay, this was measured on Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start6 Apr 2018
- Primary completion13 May 2019
- Study completion13 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Georgia State University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, James Lewis, University of Pennsylvania
- Investigators
- Jim Lewis, MD, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03440229
- Sponsor's protocol ID
- 828422
- Other IDs
- R21DK115180
- Acronym
- FRESH
- Status last verified
- Sep 2021
- First submitted
- 5 Feb 2018
- Last updated
- 19 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Doucet E, Pomerleau M, Harper ME. Fasting and postprandial total ghrelin remain unchanged after short-term energy restriction. J Clin Endocrinol Metab. 2004 Apr;89(4):1727-32. doi: 10.1210/jc.2003-031459.
PubMed 15070937Chassaing B, Compher C, Bonhomme B, Liu Q, Tian Y, Walters W, Nessel L, Delaroque C, Hao F, Gershuni V, Chau L, Ni J, Bewtra M, Albenberg L, Bretin A, McKeever L, Ley RE, Patterson AD, Wu GD, Gewirtz AT, Lewis JD. Randomized Controlled-Feeding Study of Dietary Emulsifier Carboxymethylcellulose Reveals Detrimental Impacts on the Gut Microbiota and Metabolome. Gastroenterology. 2022 Mar;162(3):743-756. doi: 10.1053/j.gastro.2021.11.006. Epub 2021 Nov 11.
PubMed 34774538
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Research of Emulsifiers in Humans
- ClinicalTrials.gov ID
- NCT03440229
- Acronym / sponsor ID
- FRESH / 828422
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Georgia State University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 6 Apr 2018 (actual)
- Primary completion
- 13 May 2019 (actual)
- Study completion
- 13 May 2019 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Posted 16 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized double-blind study of the effect of carboxymethylcellulose (CMC) on stool microbiota composition, microbiota localization, and metabolic parameters in healthy subjects. It includes a 11-day in-patient stay, randomization to an emulsifier-free group or a CMC group with the same diet except baked goods/sorbet with added CMC at 15g/person/day.
Detailed description
This is a randomized double-blind, controlled feeding experiment examining the effect of CMC on the stool microbiota composition, gene expression, and microbiota localization with respect to the epithelium. In addition, the investigators will assess the impact of CMC exposure in the diet on markers of metabolic syndrome including response to oral glucose tolerance testing and other plasma metabolite measurements.
Sixteen healthy volunteers were be recruited. 3 were admitted for 17 days and 13 participants were admitted for an 11-day in-patient study. All participants received 3 full days of freshly prepared emulsifier-free food to begin the study. This will be called the "washout period". Those will a 17 day stay received the wash out diet while inpatient and those with an 11 day stay received the wash out dies while out patient. Participants will then be randomized into an "emulsifier-free" arm and a "CMC" arm in a 1:1 ratio. Both arms will continue the same diet except that the "CMC" arm's brownie and sorbet will have CMC added to achieve a level of 15 gm per person per day consumption. Serial collection of fecal, plasma, urine and mucosal biopsy samples will be performed to investigate the extent to which CMC consumption by humans impacts the gut microbiota and its interaction with the host parameters related to inflammation and metabolism. Participants will have daily urine and stool collections. Sigmoidoscopies and glucose tolerance testing will be completed on the day prior to the start of the intervention and the last day of the inpatient stay (Days 4 and 17 for the 3 participants with a 17 day stay and days 1 and 11 for participants with an 11 day stay. Blood samples were collected on days 1-4, 5, 8, 10, 12, 15, and 17 for those with a 17 day inpatient stay and 1-4, 8, 10, and 11 for those with an 11 day stay.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emuslfier-free diet | No intervention | –This is western style diet prepared without any emulsifiers. Emulsifier free brownies and sorbet are provided daily. |
| Emulsifier-containing diet | Experimental | Other: Emulsifier-containing dietThis is a western style diet prepared without any emulsifiers with the exception of the CMC that is included in brownies and sorbet that are provided daily. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participant is capable of giving informed consent
- Participant is age 18 to 60 years
Key exclusion criteria (28 listed)
- Diagnosis with Inflammatory Bowel Disease (IBD), celiac disease, or other chronic intestinal disorders. Since we are interested in assessing the impact of diet on the microbiome in the absence of pathologic inflammation, we will exclude participants with chronic intestinal abnormalities.
- Baseline bowel frequency less than every 2 days or greater than 3 times daily. Normal bowel frequency is every 3rd day to 3 times per day.20-23 Although unknown, stool frequency could be related to the microbiome composition.24-26 Furthermore, change in diet could alter baseline stool frequency, potentially causing diarrhea, particularly in those with high baseline stool frequency, or severe constipation in those with low stool frequency. To avoid the need for use of antidiarrheal medications or laxatives, which themselves could alter the microbiome composition, these patients will be excluded.
- Current smoker. What effect smoking has on the microbiome of the gut is unknown. Furthermore, because our hospital is a smoke-free environment, volunteers will not be able to smoke. Thus, inclusion of smokers would increase the risk of early withdrawal from the study.
- Body Mass Index (BMI) <18.5 or >40 at screening. Volunteers with BMI below normal27 will be excluded to prevent inclusion of participants with a subclinical systemic disease that may influence the gut microbiome. Volunteers with severe obesity will be excluded as obesity may be associated with altered gut microbiome composition.
- More than two of the criteria for metabolic syndrome:
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 |
|---|---|---|
| Emulsifier-containing dietAlso: Carboxymethylcellulose (CMC)CMC is one of many synthetic dietary emulsifiers that are incorporated into a variety of processed foods. We have recently shown that, in mice, consumption of P80 and CMC, alters microbiota composition, have pro-inflammatory potential and promote microbiota encroachment into the colonic mucosa, low-grade inflammation, and metabolic syndrome. However, it is not known whether these compounds have similar effects in humans. We would like to study these effects in the human gut microbiota. | Other | Emulsifier-containing diet |
Primary outcome
Distance of Nearest Bacteria to the Epithelium
Time frame: last day of inpatient stay (either day 17 for the 3 participants with a 17 day inpatient stay or day 11 for the 13 participants with an 11 day inpatient stay.)
Measured distance from the epithelium to the nearest bacteria under high powered microscopy; The measurements were taken on the last day of the diet intervention. An average of 3 measurements was taken.
5 secondary outcomes
Change in Weight
Time frame: For 3 participants with a 17 day stay, weight was measured on Day 4 and Day 17 of the inpatient stay. For 13 participants with an 11 day stay, weight was measured on Day 1 and Day 11 of the inpatient stay.
Area Under Glucose Concentration Curve
Time frame: For 3 participants with a 17 day stay, area under the glucose curve was measured on days 4 and 17 of the inpatient stay . For 13 participanst with an 11 day stay, area under the glucose curve was measured on days 1 and Day 11 of the inpatient stay.
Area Under Insulin Concentration Curve
Time frame: For 3 pts. with 17 day stays, area under the curve was measured on days 4 and 17 of the inpatient stay. For 13 pts. with 11 day stays, area under the curve was measured on days 1 and Day 11 of the inpatient stay.
Visual Analog Scale Measurements - Satiety/Hunger - Change From Baseline
Time frame: Measured at end of inpatient stay (Day 17 for 3 participants and Day 11 for 13 participants) comparing it to the study start (prior to diet intervention; either day 4 for the 3 participants or day 1 for 13 participants.
Fecal Lipocalin-2
Time frame: For the 3 participants with a 17 day inpatiet stay, this was measured on Day 17. For the 13 participants with an 11 day stay, this was measured on Day 11
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15070937Doucet E, Pomerleau M, Harper ME. Fasting and postprandial total ghrelin remain unchanged after short-term energy restriction. J Clin Endocrinol Metab. 2004 Apr;89(4):1727-32. doi: 10.1210/jc.2003-031459.
- Derived from this study: PubMed 34774538Chassaing B, Compher C, Bonhomme B, Liu Q, Tian Y, Walters W, Nessel L, Delaroque C, Hao F, Gershuni V, Chau L, Ni J, Bewtra M, Albenberg L, Bretin A, McKeever L, Ley RE, Patterson AD, Wu GD, Gewirtz AT, Lewis JD. Randomized Controlled-Feeding Study of Dietary Emulsifier Carboxymethylcellulose Reveals Detrimental Impacts on the Gut Microbiota and Metabolome. Gastroenterology. 2022 Mar;162(3):743-756. doi: 10.1053/j.gastro.2021.11.006. Epub 2021 Nov 11.
- 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.
Jim Lewis, MD, MSCE principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emulsifier-containing diet in people with Healthy, run by University of Pennsylvania 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 2 inclusion and 28 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 19 Oct 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 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?
Yes. Results are posted in the registry (first posted 16 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Distance of Nearest Bacteria to the Epithelium (time frame: last day of inpatient stay (either day 17 for the 3 participants with a 17 day inpatient stay or day 11 for the 13 participants with an 11 day inpatient stay.)). 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 NCT03440229, which also lists 2 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 19 Oct 2021.