Clostridium DifficileNCT03889808
Seroprevalence of Anti-bodies Against Clostridium Difficile Toxins and Prevalence of Asymptomatic Carriage of Clostridium Difficile in IBD Patients.
An observational study of Clostridium Difficile and Inflammatory Bowel Diseases, run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial summary
The objective of this study to evaluate the seroprevalence of anti-bodies against C. difficile toxins A and B and the asymptomatic carriage of C. difficile in IBD patients according to the need and type of immunosuppressive therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Clostridium Difficile, Inflammatory Bowel Diseases
- What is being tested?
- Determination of serum anti-toxin Abs for C. difficile
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2014to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study would include 400 patients with IBD (Crohn's disease and ulcerative colitis).
Who may be able to join
- Signed informed consent
- Diagnosed of IBD, either Crohn's disease or ulcerative colitis
- Age: >18 and <65 years
- Time since diagnoses of IBD ≥ 6 months
- Present with the criteria included in any of the 4 specified groups in the study population
Who cannot join
- History of documented CDI
- Active CDI at the moment of study inclusion
- Any of the following immunosuppressive conditions: HIV infection, Liver cirrhosis, CKD stage IV, Receiving chemotherapy, Transplant (solid organ or hematological), Concomitant neoplasia, Hypogammaglobinemia.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Claudia Arajol, MD, carajol@bellvitgehospital.cat
About this study
The objective of this study to evaluate the seroprevalence of anti-bodies against C. difficile toxins A and B and the asymptomatic carriage of C. difficile in IBD patients according to the need and type of immunosuppressive therapy. The ultimate goal is to identify, among IBD patients, those with the highest risk of CDI.
- Conditions
- Clostridium Difficile, Inflammatory Bowel Diseases
- Being tested
- Determination of serum anti-toxin Abs for C. difficile
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determination of serum anti-toxin Abs for C. difficileDiagnostic test
Also called Stool culture for C. difficile
| Study group | Role | What they receive |
|---|---|---|
| Non immunosuppressed patients | without treatment or treated with Salicylates and that have not received immunosuppressive therapy, steroids, or biologics in the last 6 months. Receives: Diagnostic Test: Determination of serum anti-toxin Abs for C. difficile | |
| Patients with immunosuppressive therapy | Azathioprine, 6-Mercaptopurine, Methotrexate in standard dosage at least the past 6 months and that have not received steroids or biologics in the last 6 months. Receives: Diagnostic Test: Determination of serum anti-toxin Abs for C. difficile | |
| Patients with biologic agents | in standard dosage at least the past 6 months and that have not received steroids in the previous 6 months. Receives: Diagnostic Test: Determination of serum anti-toxin Abs for C. difficile | |
| Patients with steroid treatment | Must have received daily steroid treatment ≥ 20 mg for ≥ 2 weeks. Receives: Diagnostic Test: Determination of serum anti-toxin Abs for C. difficile | |
| Healthy subjects | A healthy subject is defined as not having and immunosuppressive underlying condition, not receiving immunosuppressive therapy, has not received antibiotic treatment in the last 6 months, has no past C. difficile infections and has not been in contact with the health care system or hospitalized in the previous 6 months. Receives: Diagnostic Test: Determination of serum anti-toxin Abs for C. difficile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Clostridium difficile anti-toxin Abs in patients with IBD
Determination of serum anti-toxin Abs for C. difficile with ELISA (enzyme-linked immunosorbent assay). The concentration of C. difficile anti-toxin Abs will be categorized as: < 25 percentile: Low, >26 < 75 percentiles: Intermediate, >76 <90 percentiles: High, >91 percentile: Very high.
Measured: 0 days
Prevalence of asymptomatic carrier of Clostridium difficile in patients with IBD
Stool testing for C. difficile as part of a multiple step algorithm: GDH (glutamate dehydrogenase), toxin EIA (enzyme immunoassay) test and C. difficile culture.
Measured: 0 days
Study the relationship between the different maintenance therapies for IBD and C. difficile anti-toxin Abs and asymptomatic carriers.
Measured: 0 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study startMar 2014
- Primary completionJan 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Arajol Gonzalez, Hospital Universitari de Bellvitge
- Investigators
- Jordi Guardiola, MD, Principal investigator, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889808
- Sponsor's protocol ID
- JGC-INM-2014-01
- Status last verified
- Mar 2019
- First submitted
- 22 Mar 2019
- Last updated
- 2 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroprevalence of Anti-bodies Against Clostridium Difficile Toxins and Prevalence of Asymptomatic Carriage of Clostridium Difficile in IBD Patients.
- ClinicalTrials.gov ID
- NCT03889808
- Acronym / sponsor ID
- JGC-INM-2014-01
- Conditions
- Clostridium Difficile, Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 26 Mar 2019 (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 objective of this study to evaluate the seroprevalence of anti-bodies against C. difficile toxins A and B and the asymptomatic carriage of C. difficile in IBD patients according to the need and type of immunosuppressive therapy. The ultimate goal is to identify, among IBD patients, those with the highest risk of CDI.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Non immunosuppressed patients | – | Diagnostic Test: Determination of serum anti-toxin Abs for C. difficilewithout treatment or treated with Salicylates and that have not received immunosuppressive therapy, steroids, or biologics in the last 6 months. |
| Patients with immunosuppressive therapy | – | Diagnostic Test: Determination of serum anti-toxin Abs for C. difficileAzathioprine, 6-Mercaptopurine, Methotrexate in standard dosage at least the past 6 months and that have not received steroids or biologics in the last 6 months. |
| Patients with biologic agents | – | Diagnostic Test: Determination of serum anti-toxin Abs for C. difficilein standard dosage at least the past 6 months and that have not received steroids in the previous 6 months. |
| Patients with steroid treatment | – | Diagnostic Test: Determination of serum anti-toxin Abs for C. difficileMust have received daily steroid treatment ≥ 20 mg for ≥ 2 weeks. |
| Healthy subjects | – | Diagnostic Test: Determination of serum anti-toxin Abs for C. difficileA healthy subject is defined as not having and immunosuppressive underlying condition, not receiving immunosuppressive therapy, has not received antibiotic treatment in the last 6 months, has no past C. difficile infections and has not been in contact with the health care system or hospitalized in the previous 6 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study would include 400 patients with IBD (Crohn's disease and ulcerative colitis).
Key inclusion criteria (5 listed)
- Signed informed consent
- Diagnosed of IBD, either Crohn's disease or ulcerative colitis
- Age: >18 and <65 years
- Time since diagnoses of IBD ≥ 6 months
- Present with the criteria included in any of the 4 specified groups in the study population
Key exclusion criteria (3 listed)
- History of documented CDI
- Active CDI at the moment of study inclusion
- Any of the following immunosuppressive conditions: HIV infection, Liver cirrhosis, CKD stage IV, Receiving chemotherapy, Transplant (solid organ or hematological), Concomitant neoplasia, Hypogammaglobinemia.
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 |
|---|---|---|
| Determination of serum anti-toxin Abs for C. difficileAlso: Stool culture for C. difficile | Diagnostic test | Healthy subjects, Non immunosuppressed patients, Patients with biologic agents, Patients with immunosuppressive therapy, Patients with steroid treatment |
Primary outcome
Prevalence of Clostridium difficile anti-toxin Abs in patients with IBD
Time frame: 0 days
Determination of serum anti-toxin Abs for C. difficile with ELISA (enzyme-linked immunosorbent assay). The concentration of C. difficile anti-toxin Abs will be categorized as: < 25 percentile: Low, >26 < 75 percentiles: Intermediate, >76 <90 percentiles: High, >91 percentile: Very high.
Prevalence of asymptomatic carrier of Clostridium difficile in patients with IBD
Time frame: 0 days
Stool testing for C. difficile as part of a multiple step algorithm: GDH (glutamate dehydrogenase), toxin EIA (enzyme immunoassay) test and C. difficile culture.
Study the relationship between the different maintenance therapies for IBD and C. difficile anti-toxin Abs and asymptomatic carriers.
Time frame: 0 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Clostridium Difficile
Not yet recruitingObservational study
Epidemiology of Clostridioides Difficile Infection (CDI) in Long-term Care Facilities, Assessment of Professional Practices Related to CDI Risk Prevention, and Strategies for Improving Care.
Clostridioides Difficile Infection
Active, not recruitingPhase 2
Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
Allogeneic Hematopoietic Stem Cell
RecruitingPhase 3
A Study to Learn About a Clostridioides Difficile Vaccine in People 65 Years of Age and Older
Clostridoides Difficile Associated Disease
Active, not recruitingObservational study
C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.
Clostridioides Difficile Infection Recurrence
RecruitingPhase 3
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Clostridium Difficile, Clostridium Difficile Infections
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.
Jordi Guardiola, MD principal investigator
Hospital Universitari de Bellvitge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clostridium Difficile and Inflammatory Bowel Diseases, run by Hospital Universitari de Bellvitge at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 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 2 Apr 2019. 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 Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clàudia Arajol, MD (+34932607500 ext. 8091, carajol@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Clostridium difficile anti-toxin Abs in patients with IBD (time frame: 0 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2019.