Clostridium DifficilePhase 3NCT02774382
Rectal Bacteriotherapy, Fecal Microbiota Transplantation or Oral Vancomycin Treatment of Recurrent Clostridium Difficile Infections
A Phase 3 study testing Vancomycin, Fecal microbiota transplantation and Rectal bacteriotherapy in people with Clostridium Difficile, run by Hvidovre University Hospital at 2 sites in Denmark.
Trial summary
The purpose of the study is to investigate if treatment with fecal microbiota transplantation or rectal bacteriotherapy is superior to standard vancomycin in patients with recurrent Clostridium Difficile infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile
- What is being tested?
- Vancomycin, Fecal microbiota transplantation and Rectal bacteriotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 May 2017to Jan 2019
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Verified recurrent CDI with symptoms of CDI and microbiological verification (PCR).
- Previously treated for CDI with at least 10 days of vancomycin or metronidazole.
- Be able to read and understand Danish.
Who cannot join
- Life expectancy < 3 months.
- Allergy toward vancomycin
- Other infection in the GI tract with clinical symptoms similar to CDI.
- Other illness in the GI tract with clinical symptoms similar to CDI.
- Use of antibiotics for more than 14 days treating other infections
- Planning pregnancy, pregnancy or breast feeding.
- Severe immune suppression which makes FMT/RBT relatively contraindicated
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
Hvidovre Hospital
Hvidovre, 2650
Mahtab Chehri, MD, +4538626785, mahtab.chehri.02@regionh.dk
Andreas M Petersen, Clinical associate professor
- Recruiting
Køge sygehus
Køge, 4600
Anne R Olsen, MD
Peter M Bytzer, Professor MD PhD
About this study
The purpose of the study is to investigate if treatment with fecal microbiota transplantation or rectal bacteriotherapy is superior to standard vancomycin in patients with recurrent Clostridium Difficile infections.
Read the detailed description
Clostridium difficile infection (CDI) is the most common nosocomial infection in the western world. CDI is associated with high morbidity and mortality and is a great burden for the health care system leading Center of Disease Control and Prevention (CDC) to identify it as one of three most important/urgent threats to public health.
Despite antimicrobial treatment of CDI, 20% of the patients have recurrence of CDI. Due to a dysbiosis in the gut microbiota the antimicrobial treatment seems to be less effective.
Fecal microbiota transplantation (FMT) is an alternative treatment for recurrent CDI. Studies have shown a cure rate up to 90% in patients with recurrent CDI. One alternative to FMT is rectal bacteriotherapy (RBT) which is a standardized bacterial culture made in the laboratory consisting of 12 different bacteria. RBT has never been investigated in a clinical trial.
The project is a randomized controlled trial including 450 patients with recurrent CDI will be, after accepting participation, allocated to receive vancomycin alone or vancomycin followed by either FMT or RBT. The patients will be followed up for 180 days. Cure is defined as resolution of CDI symptoms 90 days after treatment.
- Conditions
- Clostridium Difficile
- Being tested
- Vancomycin, Fecal microbiota transplantation, Rectal bacteriotherapy
- Keywords
- Recurrence, Infection
- Medical subject headings
- Recurrence, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
Already incl. in arm description
Fecal microbiota transplantationDrug
Already incl. in arm description
Rectal bacteriotherapyDrug
Already incl. in arm description
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin | Active comparator | Oral vancomycin according to number of recurrences (Danish guidelines):
First recurrence: Capsule vancomycin 125 mg x 4 p.o. times daily for 14 days
≥2 recurrences:
* capsule vancomycin 125 mg x 4 times daily p.o. for 14 days followed by
* capsule vancomycin 125 mg x 2 times daily p.o. for 7 days followed by
* capsule vancomycin 125 mg x 1 times daily p.o. for 7 days followed by
* capsule vancomycin 125 mg x 1 p.o. every second day for 7 days followed by
* capsule vancomycin 125 mg x 1 p.o. every third day for 14 days Receives: Drug: Vancomycin |
| Vancomycin + fecal microbiota transplantation | Experimental | Capsule vancomycin 125 mg x 4 times daily p.o. for 7-14 days followed by Fecal Microbiota Transplantation with 200 ml fecal suspension administrated with a rectal catheter. Receives: Drug: Vancomycin; Drug: Fecal microbiota transplantation |
| Vancomycin + rectal bacteriotherapy | Experimental | Capsule vancomycin 125 mg x 4 times daily p.o. for 7-14 days followed by Rectal bacteriotherapy with 200 ml suspension of a fixed mixture of bacterial strains administrated with a rectal catheter. Receives: Drug: Vancomycin; Drug: Rectal bacteriotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure of recurrent Clostridium difficile infection defined as patient-reported abscence of Clostridium difficile infection 90 days after treatment.
Clinical cure defined as patient-reported abscence of Clostridium difficile infection 90 days after treatment. The investigator will call the patient by telephone and fill out af digital questionnaire.
Measured: 90 days
Secondary outcomes (15)
Early or late recurrence of CDI after the end of treatment defined as recurrence of symptoms of CDI and a positive stool sample with Clostridium difficile (PCR).
Patient with recurrence of CDI in the follow up period will be categorized as an early recurrence if the recurrence is in the first 30 days after treatment and as a late recurrence if the recurrence is after 180 days after treatment. The investigator will call the patient by telephone and fill out af digital questionnaire and thereafter categorize the patient.
Measured: 30 and 180 days after ended treatment
Days with diarrhea
Measured: 1, 4, 8 and 12 days after ended treatment
CDI-associated hospital admission and hospital admission of other causes in the follow-up period
Measured: 180 days after ended treatment
CDI-associated hospital outpatient contact and hospital outpatient contact of other causes in the follow-up period
Measured: 180 days after ended treatment
CDI-associated mortality and all-cause mortality
Measured: 30, 90 and 180 days after ended treatment
Compare numbers of patients with clinical cure after study treatment divided into two groups depending on numbers of recurrences of CDI.
Clinical cure is defined as patient-reported abscence of Clostridium difficile infection 90 days after treatment. The investigator will call the patient by telephone and fill out a digital questionnaire. Number of patients with clinical cure of recurrent Clostridium difficile infection will be divided into two groups according to numbers of recurrences of CDI;
- Group 1; patients with one recurrence
- Group 2; patients with 2 or more recurrences. The division will be done based on patient records and the questionnaire. The information will be aggregated in the digital journal unique to this trial. The numbers of patients with clinical cure in the two groups will be compared to see if one group response better to study treatment than the other.
Measured: 90 days after ended treatment
Effect of the treatment depending on the CD strain - i.e. toxin B CDI cases, toxin B plus binary toxin CDI cases and CD027 CDI cases.
The investigator will call the patient by telephone and fill out af digital questionnaire. The lab result will give the investigator information about which strain the patient was infected with and this will be aggregated in the digital patient journal.
Measured: 90 days after ended treatment
Effect of the treatment depending on the patients serum-level of antibodies towards toxin A and B at the time of inclusion.
At inclusion the investigator will collect a blood sample to analysis for toxin A and B antibodies. The lab result will be aggregated in the digital patient journal.
Measured: 90 days after ended treatment
Side effects in the three treatment arms
Measured: 14 days after ended treatment
Characterisation of the gut microbiota before and after treatment with FMT/RBT in conjunction with characterisation of the donor's microbiota or the RBT bacterial mix.
Performed in a subgroup of patients.
Measured: 180 days after ended treatment
Other antibiotic treatments associated with new recurrences of CDI
The investigator will call the patient by telephone and fill out af digital questionnaire. Furthermore the investigator has access to a database with all prescription drugs incl. antibiotics. These informations will be collected and aggregated in the digital patient journal unique for this study.
Measured: Within 180 days after ended treatment
Evaluation of the composition of bile acids before and after treatment with FMT/RBT.
Analyzed in conjunction with the microbiota composition and the treatment effect. Performed in a subgroup of patients.
Measured: 90 days after ended treatment
Characterisation of the CD strains by whole genome sequencing
Characterisation of the CD strains involved to determine if a potential recurrence is a true recurrence or a reinfection with another strain. Whole genome sequencing will be performed by the department of Clinical Microbiology in Hvidovre Hospital. This information will be collected by the investigator and aggregated in the digital patient journal unique for this trial.
Measured: 90 days after ended treatment
Identification of age as a risk factor for treatment success/failure
The investigator will call the patient by telephone for information about abscence of CDI and fill out af digital questionnaire. This information and the patient's age will be aggregated in the digital patient journal.
Measured: 90 days after ended treatment
Identifying if Charlson comorbidity index is associated to treatment success/failure.
At inclusion the patient's Charlson Comorbidity index will be calculated and put in the patient's record unique to this trial.
Measured: 90 days after ended treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study start1 May 2017
- Primary completionDec 2018 (estimated)
- Study completionJan 2019 (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 Clostridium DifficileStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Munk Petersen, Hvidovre University Hospital
- Investigators
- Andreas M Petersen, MD PhD, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774382
- Sponsor's protocol ID
- SJ-478
- Status last verified
- Sep 2017
- First submitted
- 4 Apr 2016
- Last updated
- 27 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kelly CP, LaMont JT. Clostridium difficile--more difficult than ever. N Engl J Med. 2008 Oct 30;359(18):1932-40. doi: 10.1056/NEJMra0707500. No abstract available.
PubMed 18971494Lessa FC, Mu Y, Bamberg WM, Beldavs ZG, Dumyati GK, Dunn JR, Farley MM, Holzbauer SM, Meek JI, Phipps EC, Wilson LE, Winston LG, Cohen JA, Limbago BM, Fridkin SK, Gerding DN, McDonald LC. Burden of Clostridium difficile infection in the United States. N Engl J Med. 2015 Feb 26;372(9):825-34. doi: 10.1056/NEJMoa1408913.
PubMed 25714160Olsen MA, Yan Y, Reske KA, Zilberberg MD, Dubberke ER. Recurrent Clostridium difficile infection is associated with increased mortality. Clin Microbiol Infect. 2015 Feb;21(2):164-70. doi: 10.1016/j.cmi.2014.08.017. Epub 2014 Oct 12.
PubMed 25658560van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.
PubMed 23323867Cammarota G, Masucci L, Ianiro G, Bibbo S, Dinoi G, Costamagna G, Sanguinetti M, Gasbarrini A. Randomised clinical trial: faecal microbiota transplantation by colonoscopy vs. vancomycin for the treatment of recurrent Clostridium difficile infection. Aliment Pharmacol Ther. 2015 May;41(9):835-43. doi: 10.1111/apt.13144. Epub 2015 Mar 1.
PubMed 25728808Tvede M, Tinggaard M, Helms M. Rectal bacteriotherapy for recurrent Clostridium difficile-associated diarrhoea: results from a case series of 55 patients in Denmark 2000-2012. Clin Microbiol Infect. 2015 Jan;21(1):48-53. doi: 10.1016/j.cmi.2014.07.003. Epub 2014 Oct 12.
PubMed 25636927
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectal Bacteriotherapy, Fecal Microbiota Transplantation or Oral Vancomycin Treatment of Recurrent Clostridium Difficile Infections
- ClinicalTrials.gov ID
- NCT02774382
- Acronym / sponsor ID
- SJ-478
- Conditions
- Clostridium Difficile
- Keywords
- Recurrence, Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 17 May 2016 (estimated)
- 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 the study is to investigate if treatment with fecal microbiota transplantation or rectal bacteriotherapy is superior to standard vancomycin in patients with recurrent Clostridium Difficile infections.
Detailed description
Clostridium difficile infection (CDI) is the most common nosocomial infection in the western world. CDI is associated with high morbidity and mortality and is a great burden for the health care system leading Center of Disease Control and Prevention (CDC) to identify it as one of three most important/urgent threats to public health.
Despite antimicrobial treatment of CDI, 20% of the patients have recurrence of CDI. Due to a dysbiosis in the gut microbiota the antimicrobial treatment seems to be less effective.
Fecal microbiota transplantation (FMT) is an alternative treatment for recurrent CDI. Studies have shown a cure rate up to 90% in patients with recurrent CDI. One alternative to FMT is rectal bacteriotherapy (RBT) which is a standardized bacterial culture made in the laboratory consisting of 12 different bacteria. RBT has never been investigated in a clinical trial.
The project is a randomized controlled trial including 450 patients with recurrent CDI will be, after accepting participation, allocated to receive vancomycin alone or vancomycin followed by either FMT or RBT. The patients will be followed up for 180 days. Cure is defined as resolution of CDI symptoms 90 days after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vancomycin | Active comparator | Drug: VancomycinOral vancomycin according to number of recurrences (Danish guidelines): First recurrence: Capsule vancomycin 125 mg x 4 p.o. times daily for 14 days ≥2 recurrences: * capsule vancomycin 125 mg x 4 times daily p.o. for 14 days followed by * capsule vancomycin 125 mg x 2 times daily p.o. for 7 days followed by * capsule vancomycin 125 mg x 1 times daily p.o. for 7 days followed by * capsule vancomycin 125 mg x 1 p.o. every second day for 7 days followed by * capsule vancomycin 125 mg x 1 p.o. every third day for 14 days |
| Vancomycin + fecal microbiota transplantation | Experimental | Drug: Vancomycin, Drug: Fecal microbiota transplantationCapsule vancomycin 125 mg x 4 times daily p.o. for 7-14 days followed by Fecal Microbiota Transplantation with 200 ml fecal suspension administrated with a rectal catheter. |
| Vancomycin + rectal bacteriotherapy | Experimental | Drug: Vancomycin, Drug: Rectal bacteriotherapyCapsule vancomycin 125 mg x 4 times daily p.o. for 7-14 days followed by Rectal bacteriotherapy with 200 ml suspension of a fixed mixture of bacterial strains administrated with a rectal catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Verified recurrent CDI with symptoms of CDI and microbiological verification (PCR).
- Previously treated for CDI with at least 10 days of vancomycin or metronidazole.
- Be able to read and understand Danish.
Key exclusion criteria (7 listed)
- Life expectancy < 3 months.
- Allergy toward vancomycin
- Other infection in the GI tract with clinical symptoms similar to CDI.
- Other illness in the GI tract with clinical symptoms similar to CDI.
- Use of antibiotics for more than 14 days treating other infections
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 |
|---|---|---|
| VancomycinAlready incl. in arm description | Drug | Vancomycin, Vancomycin + fecal microbiota transplantation, Vancomycin + rectal bacteriotherapy |
| Fecal microbiota transplantationAlready incl. in arm description | Drug | Vancomycin + fecal microbiota transplantation |
| Rectal bacteriotherapyAlready incl. in arm description | Drug | Vancomycin + rectal bacteriotherapy |
Primary outcome
Clinical cure of recurrent Clostridium difficile infection defined as patient-reported abscence of Clostridium difficile infection 90 days after treatment.
Time frame: 90 days
Clinical cure defined as patient-reported abscence of Clostridium difficile infection 90 days after treatment. The investigator will call the patient by telephone and fill out af digital questionnaire.
15 secondary outcomes
Early or late recurrence of CDI after the end of treatment defined as recurrence of symptoms of CDI and a positive stool sample with Clostridium difficile (PCR).
Time frame: 30 and 180 days after ended treatment
Days with diarrhea
Time frame: 1, 4, 8 and 12 days after ended treatment
CDI-associated hospital admission and hospital admission of other causes in the follow-up period
Time frame: 180 days after ended treatment
CDI-associated hospital outpatient contact and hospital outpatient contact of other causes in the follow-up period
Time frame: 180 days after ended treatment
CDI-associated mortality and all-cause mortality
Time frame: 30, 90 and 180 days after ended treatment
Compare numbers of patients with clinical cure after study treatment divided into two groups depending on numbers of recurrences of CDI.
Time frame: 90 days after ended treatment
Effect of the treatment depending on the CD strain - i.e. toxin B CDI cases, toxin B plus binary toxin CDI cases and CD027 CDI cases.
Time frame: 90 days after ended treatment
Effect of the treatment depending on the patients serum-level of antibodies towards toxin A and B at the time of inclusion.
Time frame: 90 days after ended treatment
Side effects in the three treatment arms
Time frame: 14 days after ended treatment
Characterisation of the gut microbiota before and after treatment with FMT/RBT in conjunction with characterisation of the donor's microbiota or the RBT bacterial mix.
Time frame: 180 days after ended treatment
Other antibiotic treatments associated with new recurrences of CDI
Time frame: Within 180 days after ended treatment
Evaluation of the composition of bile acids before and after treatment with FMT/RBT.
Time frame: 90 days after ended treatment
Characterisation of the CD strains by whole genome sequencing
Time frame: 90 days after ended treatment
Identification of age as a risk factor for treatment success/failure
Time frame: 90 days after ended treatment
Identifying if Charlson comorbidity index is associated to treatment success/failure.
Time frame: 90 days after ended treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2017.
- Background: PubMed 18971494Kelly CP, LaMont JT. Clostridium difficile--more difficult than ever. N Engl J Med. 2008 Oct 30;359(18):1932-40. doi: 10.1056/NEJMra0707500. No abstract available.
- Background: PubMed 25714160Lessa FC, Mu Y, Bamberg WM, Beldavs ZG, Dumyati GK, Dunn JR, Farley MM, Holzbauer SM, Meek JI, Phipps EC, Wilson LE, Winston LG, Cohen JA, Limbago BM, Fridkin SK, Gerding DN, McDonald LC. Burden of Clostridium difficile infection in the United States. N Engl J Med. 2015 Feb 26;372(9):825-34. doi: 10.1056/NEJMoa1408913.
- Background: PubMed 25658560Olsen MA, Yan Y, Reske KA, Zilberberg MD, Dubberke ER. Recurrent Clostridium difficile infection is associated with increased mortality. Clin Microbiol Infect. 2015 Feb;21(2):164-70. doi: 10.1016/j.cmi.2014.08.017. Epub 2014 Oct 12.
- Background: PubMed 23323867van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.
- Background: PubMed 25728808Cammarota G, Masucci L, Ianiro G, Bibbo S, Dinoi G, Costamagna G, Sanguinetti M, Gasbarrini A. Randomised clinical trial: faecal microbiota transplantation by colonoscopy vs. vancomycin for the treatment of recurrent Clostridium difficile infection. Aliment Pharmacol Ther. 2015 May;41(9):835-43. doi: 10.1111/apt.13144. Epub 2015 Mar 1.
- Background: PubMed 25636927Tvede M, Tinggaard M, Helms M. Rectal bacteriotherapy for recurrent Clostridium difficile-associated diarrhoea: results from a case series of 55 patients in Denmark 2000-2012. Clin Microbiol Infect. 2015 Jan;21(1):48-53. doi: 10.1016/j.cmi.2014.07.003. Epub 2014 Oct 12.
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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.
Andreas M Petersen, MD PhD principal investigator
Hvidovre University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vancomycin, Fecal microbiota transplantation and Rectal bacteriotherapy in people with Clostridium Difficile, run by Hvidovre University Hospital at 2 sites in Denmark.
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: status not confirmed, as of the sponsor's last update on 27 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Andreas M Petersen, MD, PhD (+4538625960, andreasmunkpetersen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure of recurrent Clostridium difficile infection defined as patient-reported abscence of Clostridium difficile infection 90 days after treatment. (time frame: 90 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 NCT02774382, 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 27 Sep 2017.