BerberinePhase 4BOIFIMNCT04479202
The Effect of Berberine on Intestinal Function and Inflammatory Mediators in Severe Patients With Covid-19
A Phase 4 study testing Berberine and Montmorrillonite in people with Berberine and COVID-19, run by Chinese Medical Association at 1 site in China.
Trial summary
Coronavirus disease 2019 (COVID-19) rapidly spread across China and throughout the world, causing hundreds of thousands died. Studies had shown that "cytokine storms" and subsequent multiple organ dysfunction (MODS) are important causes for disease progression and death in patients with COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Berberine and Montmorrillonite
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 8 Feb 2020to 23 Apr 2020
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients confirmed with COVID-19 and classified as severe
Who cannot join
- inflammatory bowel disease;
- have other sources of infection;
- death is anticipate within 72 hours;
- participated in other clinical trials;
- pregnant or lactating women;
Trial locations and contacts
1 site in 1 country.
About this study
Coronavirus disease 2019 (COVID-19) rapidly spread across China and throughout the world, causing hundreds of thousands died. Studies had shown that "cytokine storms" and subsequent multiple organ dysfunction (MODS) are important causes for disease progression and death in patients with COVID-19. Similar to SARS-CoV infection, SARS-CoV-2 would infect humans via binding of S-protein to angiotensin-converting enzyme 2 (ACE2), a host cell receptor, and the S protein is activated and cleaved by cellular transmembrane serine proteases, allowing the virus to release fusion peptides for membrane fusion. In addition to the lungs, ACE2 is also highly expressed in the esophagus, small intestine and colon, suggesting that the gut might also be an important target organ for SARS-CoV-2. About 8-16% of severe pneumonia cases confirmed with SARS-CoV-2 infection developed gastrointestinal symptoms such as abdominal pain, vomiting, and diarrhea. Moreover, the stool of patient with COVID-19 also positive by real-time reverse-transcriptase-polymerase-chain-reaction (rRT-PCR) assay. Furthermore, elevated faecal calprotectin was observed in patients with COVID-19 suggested an inflammatory response in the gut, which was significantly correlated with IL-6. For severe and critical cases, control "cytokine storms" and maintain intestinal microenvironment balance have been included into the Diagnosis and Treatment Guideline of patients with COVID-19 (Edition 7). Berberine is a quaternary ammonium alkaloid isolated from rhizoma coptidis. It is often used in treatment of infectious diarrhea by bacteriostasis and inhibition of intestinal gland secretion. Berberine has also been found to have a role in intestinal immune regulation, inhibiting both AP-1 and NF- B, the key factors in cell signal transduction, and reducing the inflammatory response. Investigators conducted a prospective randomized controlled clinical trial to investigate the effects of berberine on intestinal function, serum concentrations of the inflammatory biomarkers, and organ function in severe patients with SARS-CoV-2 infection.
Read the detailed description
Patients aged 18-80 years who confirmed with COVID-19 and classified as severe were enrolled in the study, and then separated randomly into two groups: a berberine group (B group) and a control group (C group). The diagnostic criteria for severe cases are in accordance with the Diagnosis and Treatment Guideline of patients with COVID-19 issued by the National Health Commission of the People's Republic of China (Edition 7). In general, patients diagnosed with COVID-19 pneumonia must also meet any of the following criteria: appears shortness of breath, respiratory rate (RR) ≥ 30 times/min; SPO2 ≤ 93% at rest; the ratio of partial oxygen pressure of arterial blood (PaO2) to oxygen absorption concentration (FiO2) ≤ 300mmHg (1mmHg=0.133KPa); pulmonary imaging showed the lesion progression >50% within 24-48 hours. All enrolled patients were given general support therapy, oxygen therapy, antiviral drugs, in combination with antibiotics and small doses of glucocorticoids if necessary, nutritional and organ function support. Patients in the berberine group (B group) were given berberine 0.3g tid orally or tube feed daily, while patients in the control group (C group) were given montmorilonite orally if they presence of diarrhea. The duration of the study intervention was 14 days and followed up to discharge. Investigators record general information about patients at admission, including age, gender, age, exposure history, time from onset of symptoms to hospital, APACHE II score, the presentation of X-ray, comorbidity, mechanical ventilation, fever or not,gastrointestinal symptoms. Investigators also evaluate the gastrointestinal function daily,including gastrointestinal symptoms (nausea, vomiting, abdominal pain, abdominal distension or diarrhoea), frequency of diarrhea, the characteristics of stool (Bristol scal). Peripheral blood are collected on day 1,3, 7 and 14 after admission to determine the level of interleukin-6 (IL-6), interleukin-1β (IL-1β), interleukin-10 (IL-10) and tumor necrosis factor (TNF-α). Laboratory tests are also performed to evaluate leucocyte, c-reactive protein (CRP), and procalcitonin (PCT) levels at the same time. Glutamate transaminase (ALT), glutamate transaminase (AST), urea nitrogen (Bun), creatinine, prothrombin time (PT), partially activated prothrombin time (APTT), and Sequential Organ Failure Assessment (SOFA) score are used to evaluate organ function on day 1,3, 7 and 14 after admission. Investigators also record the adverse events associated with the drug, length of stay and the prognosis at discharge. The patients are blinded to the group allocation. Two physicians are responsible for data processing, one is responsible for recording and collecting, and the other is responsible for checking, and they are all blind to the research.
- Being tested
- Berberine, Montmorrillonite
- Keywords
- Gastrointestinal function, inflammatory biomarkers, Organ function
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BerberineDrug
Also called Berberine Hydrochloride Tablets
Patients in the intervention group received berberine daily, regardless of gastrointestinal symptoms.If the patient has a serious drug-related adverse event, the drug will be discontinued and the patient will be excluded from the study.
MontmorrilloniteDrug
Also called Montmorrillonite Powder
Patients in the control group were routinely not given special treatment.However, if the patient has diarrhea symptoms, montmorillonite powder should be given orally.
| Study group | Role | What they receive |
|---|---|---|
| berberine group (B group) | Experimental | Patients in the B group were given berberine hydrochloride tables 0.3g tid orally or tube feed daily, until the 14th day of the study. Other treatments include general support therapy, oxygen therapy, antiviral drugs, in combination with antibiotics and small doses of glucocorticoids if necessary, nutritional and organ function support. Receives: Drug: Berberine |
| control group (C group) | Sham comparator | Patients in the C group were given montmorilonite orally if they presence of diarrhea. The other treatments were the same as in B group. Receives: Drug: Montmorrillonite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in diarrhea frequency and Bristol Stool Scale
Including diarrhea in times/day, Bristol Stool Scale (the minimum 1 and maximum 7, a higher scores mean a worse outcome) and whether patient has any one of gastrointestinal symptoms (nausea, vomiting, abdominal pain, abdominal distension or diarrhoea).
Measured: daily, from date of randomization until the date of discharge or date of death from any cause, assessed up to 2 weeks.
Secondary outcomes (7)
IL-6 (ng/ml)
evaluate inflammatory response, blood sample collected at 6:00am
Measured: baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause
IL-10（ng/ml）
evaluate inflammatory response, blood sample collected at 6:00am
Measured: baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause
IL-1β (ng/ml)
evaluate inflammatory response, blood sample collected at 6:00am
Measured: baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause
TNF-α (pg/ml)
evaluate inflammatory response, blood sample collected at 6:00am
Measured: baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause
leukocyte count (10^9/l)
evaluate inflammatory response, blood sample collected at 6:00am
Measured: baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause
c reactive protein (mg/l)
evaluate inflammatory response, blood sample collected at 6:00am
Measured: baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause
procalcitonin (ng/ml)
evaluate inflammatory response, blood sample collected at 6:00am
Measured: baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start8 Feb 2020
- Primary completion18 Apr 2020
- Study completion23 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BerberineStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Medical Association
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Wenkui Yu, M.D., Study chair, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479202
- Sponsor's protocol ID
- Berberine treats COVID-19
- Other IDs
- XJ2020005101
- Acronym
- BOIFIM
- Status last verified
- May 2020
- First submitted
- 13 May 2020
- Last updated
- 21 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have other articles about covid-19 yet to be published
Publications
Effenberger M, Grabherr F, Mayr L, Schwaerzler J, Nairz M, Seifert M, Hilbe R, Seiwald S, Scholl-Buergi S, Fritsche G, Bellmann-Weiler R, Weiss G, Muller T, Adolph TE, Tilg H. Faecal calprotectin indicates intestinal inflammation in COVID-19. Gut. 2020 Aug;69(8):1543-1544. doi: 10.1136/gutjnl-2020-321388. Epub 2020 Apr 20. No abstract available.
PubMed 32312790Jin X, Lian JS, Hu JH, Gao J, Zheng L, Zhang YM, Hao SR, Jia HY, Cai H, Zhang XL, Yu GD, Xu KJ, Wang XY, Gu JQ, Zhang SY, Ye CY, Jin CL, Lu YF, Yu X, Yu XP, Huang JR, Xu KL, Ni Q, Yu CB, Zhu B, Li YT, Liu J, Zhao H, Zhang X, Yu L, Guo YZ, Su JW, Tao JJ, Lang GJ, Wu XX, Wu WR, Qv TT, Xiang DR, Yi P, Shi D, Chen Y, Ren Y, Qiu YQ, Li LJ, Sheng J, Yang Y. Epidemiological, clinical and virological characteristics of 74 cases of coronavirus-infected disease 2019 (COVID-19) with gastrointestinal symptoms. Gut. 2020 Jun;69(6):1002-1009. doi: 10.1136/gutjnl-2020-320926. Epub 2020 Mar 24.
PubMed 32213556Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
PubMed 32171076
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Berberine on Intestinal Function and Inflammatory Mediators in Severe Patients With Covid-19
- ClinicalTrials.gov ID
- NCT04479202
- Acronym / sponsor ID
- BOIFIM / Berberine treats COVID-19
- Keywords
- Gastrointestinal function, inflammatory biomarkers, Organ function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Chinese Medical AssociationResearch network
- Study start
- 8 Feb 2020 (actual)
- Primary completion
- 18 Apr 2020 (actual)
- Study completion
- 23 Apr 2020 (actual)
- First posted
- 21 Jul 2020 (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.
Coronavirus disease 2019 (COVID-19) rapidly spread across China and throughout the world, causing hundreds of thousands died. Studies had shown that "cytokine storms" and subsequent multiple organ dysfunction (MODS) are important causes for disease progression and death in patients with COVID-19. Similar to SARS-CoV infection, SARS-CoV-2 would infect humans via binding of S-protein to angiotensin-converting enzyme 2 (ACE2), a host cell receptor, and the S protein is activated and cleaved by cellular transmembrane serine proteases, allowing the virus to release fusion peptides for membrane fusion. In addition to the lungs, ACE2 is also highly expressed in the esophagus, small intestine and colon, suggesting that the gut might also be an important target organ for SARS-CoV-2. About 8-16% of severe pneumonia cases confirmed with SARS-CoV-2 infection developed gastrointestinal symptoms such as abdominal pain, vomiting, and diarrhea. Moreover, the stool of patient with COVID-19 also positive by real-time reverse-transcriptase-polymerase-chain-reaction (rRT-PCR) assay. Furthermore, elevated faecal calprotectin was observed in patients with COVID-19 suggested an inflammatory response in the gut, which was significantly correlated with IL-6. For severe and critical cases, control "cytokine storms" and maintain intestinal microenvironment balance have been included into the Diagnosis and Treatment Guideline of patients with COVID-19 (Edition 7). Berberine is a quaternary ammonium alkaloid isolated from rhizoma coptidis. It is often used in treatment of infectious diarrhea by bacteriostasis and inhibition of intestinal gland secretion. Berberine has also been found to have a role in intestinal immune regulation, inhibiting both AP-1 and NF- B, the key factors in cell signal transduction, and reducing the inflammatory response. Investigators conducted a prospective randomized controlled clinical trial to investigate the effects of berberine on intestinal function, serum concentrations of the inflammatory biomarkers, and organ function in severe patients with SARS-CoV-2 infection.
Detailed description
Patients aged 18-80 years who confirmed with COVID-19 and classified as severe were enrolled in the study, and then separated randomly into two groups: a berberine group (B group) and a control group (C group). The diagnostic criteria for severe cases are in accordance with the Diagnosis and Treatment Guideline of patients with COVID-19 issued by the National Health Commission of the People's Republic of China (Edition 7). In general, patients diagnosed with COVID-19 pneumonia must also meet any of the following criteria: appears shortness of breath, respiratory rate (RR) ≥ 30 times/min; SPO2 ≤ 93% at rest; the ratio of partial oxygen pressure of arterial blood (PaO2) to oxygen absorption concentration (FiO2) ≤ 300mmHg (1mmHg=0.133KPa); pulmonary imaging showed the lesion progression >50% within 24-48 hours. All enrolled patients were given general support therapy, oxygen therapy, antiviral drugs, in combination with antibiotics and small doses of glucocorticoids if necessary, nutritional and organ function support. Patients in the berberine group (B group) were given berberine 0.3g tid orally or tube feed daily, while patients in the control group (C group) were given montmorilonite orally if they presence of diarrhea. The duration of the study intervention was 14 days and followed up to discharge. Investigators record general information about patients at admission, including age, gender, age, exposure history, time from onset of symptoms to hospital, APACHE II score, the presentation of X-ray, comorbidity, mechanical ventilation, fever or not,gastrointestinal symptoms. Investigators also evaluate the gastrointestinal function daily,including gastrointestinal symptoms (nausea, vomiting, abdominal pain, abdominal distension or diarrhoea), frequency of diarrhea, the characteristics of stool (Bristol scal). Peripheral blood are collected on day 1,3, 7 and 14 after admission to determine the level of interleukin-6 (IL-6), interleukin-1β (IL-1β), interleukin-10 (IL-10) and tumor necrosis factor (TNF-α). Laboratory tests are also performed to evaluate leucocyte, c-reactive protein (CRP), and procalcitonin (PCT) levels at the same time. Glutamate transaminase (ALT), glutamate transaminase (AST), urea nitrogen (Bun), creatinine, prothrombin time (PT), partially activated prothrombin time (APTT), and Sequential Organ Failure Assessment (SOFA) score are used to evaluate organ function on day 1,3, 7 and 14 after admission. Investigators also record the adverse events associated with the drug, length of stay and the prognosis at discharge. The patients are blinded to the group allocation. Two physicians are responsible for data processing, one is responsible for recording and collecting, and the other is responsible for checking, and they are all blind to the research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| berberine group (B group) | Experimental | Drug: BerberinePatients in the B group were given berberine hydrochloride tables 0.3g tid orally or tube feed daily, until the 14th day of the study. Other treatments include general support therapy, oxygen therapy, antiviral drugs, in combination with antibiotics and small doses of glucocorticoids if necessary, nutritional and organ function support. |
| control group (C group) | Sham comparator | Drug: MontmorrillonitePatients in the C group were given montmorilonite orally if they presence of diarrhea. The other treatments were the same as in B group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients confirmed with COVID-19 and classified as severe
Key exclusion criteria (5 listed)
- inflammatory bowel disease;
- have other sources of infection;
- death is anticipate within 72 hours;
- participated in other clinical trials;
- pregnant or lactating women;
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 |
|---|---|---|
| BerberineAlso: Berberine Hydrochloride TabletsPatients in the intervention group received berberine daily, regardless of gastrointestinal symptoms.If the patient has a serious drug-related adverse event, the drug will be discontinued and the patient will be excluded from the study. | Drug | berberine group (B group) |
| MontmorrilloniteAlso: Montmorrillonite PowderPatients in the control group were routinely not given special treatment.However, if the patient has diarrhea symptoms, montmorillonite powder should be given orally. | Drug | control group (C group) |
Primary outcome
Changes in diarrhea frequency and Bristol Stool Scale
Time frame: daily, from date of randomization until the date of discharge or date of death from any cause, assessed up to 2 weeks.
Including diarrhea in times/day, Bristol Stool Scale (the minimum 1 and maximum 7, a higher scores mean a worse outcome) and whether patient has any one of gastrointestinal symptoms (nausea, vomiting, abdominal pain, abdominal distension or diarrhoea).
7 secondary outcomes
IL-6 (ng/ml)
Time frame: baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause
IL-10（ng/ml）
Time frame: baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause
IL-1β (ng/ml)
Time frame: baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause
TNF-α (pg/ml)
Time frame: baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause
leukocyte count (10^9/l)
Time frame: baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause
c reactive protein (mg/l)
Time frame: baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause
procalcitonin (ng/ml)
Time frame: baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause
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 21 Jul 2020.
- Results publication: PubMed 32312790Effenberger M, Grabherr F, Mayr L, Schwaerzler J, Nairz M, Seifert M, Hilbe R, Seiwald S, Scholl-Buergi S, Fritsche G, Bellmann-Weiler R, Weiss G, Muller T, Adolph TE, Tilg H. Faecal calprotectin indicates intestinal inflammation in COVID-19. Gut. 2020 Aug;69(8):1543-1544. doi: 10.1136/gutjnl-2020-321388. Epub 2020 Apr 20. No abstract available.
- Results publication: PubMed 32213556Jin X, Lian JS, Hu JH, Gao J, Zheng L, Zhang YM, Hao SR, Jia HY, Cai H, Zhang XL, Yu GD, Xu KJ, Wang XY, Gu JQ, Zhang SY, Ye CY, Jin CL, Lu YF, Yu X, Yu XP, Huang JR, Xu KL, Ni Q, Yu CB, Zhu B, Li YT, Liu J, Zhao H, Zhang X, Yu L, Guo YZ, Su JW, Tao JJ, Lang GJ, Wu XX, Wu WR, Qv TT, Xiang DR, Yi P, Shi D, Chen Y, Ren Y, Qiu YQ, Li LJ, Sheng J, Yang Y. Epidemiological, clinical and virological characteristics of 74 cases of coronavirus-infected disease 2019 (COVID-19) with gastrointestinal symptoms. Gut. 2020 Jun;69(6):1002-1009. doi: 10.1136/gutjnl-2020-320926. Epub 2020 Mar 24.
- Results publication: PubMed 32171076Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
- Individual participant dataSharing planned: No. We have other articles about covid-19 yet to be published
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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.
Wenkui Yu, M.D. study chair
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Berberine and Montmorrillonite in people with Berberine and COVID-19, run by Chinese Medical Association 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 1 inclusion and 5 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 21 Jul 2020. 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. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in diarrhea frequency and Bristol Stool Scale (time frame: daily, from date of randomization until the date of discharge or date of death from any cause, assessed up to 2 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04479202, which also lists 3 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 21 Jul 2020.