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Host Immune Response to Clostridium Difficile Infection (ICD)

Factors Associated With Relapses in Patients Suffering From Clostridium Difficile Infection: Immune Response

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02440438
Acronym
ICD
Enrollment
56
Registered
2015-05-12
Start date
2014-01-31
Completion date
2016-08-31
Last updated
2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diarrhea Due to Clostridium Difficile

Keywords

Clostridium difficile, recurrence, relapse, antibodies, immune response, prognosis

Brief summary

Clostridium difficile is responsible for up to 25% of reported antibiotic associated diarrhea cases and virtually all cases of pseudomembranous colitis (PMC). The clinical spectrum of C. difficile infection (CDI) varies in severity from asymptomatic carriage to self-limited, mild, watery diarrhea, to PMC, intestinal perforation, toxic megacolon, sepsis, fulminant colitis, and death. In the past decade, the 027/NAP1/BI strain has emerged world-wide and has been implicated in large outbreaks with increased severity, frequent recurrence, and significant mortality. The host immune responses can influence the severity of CDI and play crucial roles in CDI onset, progression, and overall prognosis. Low serum concentrations of antibodies directed against the toxins A&B of C. difficile have been associated with a higher risk of recurrence. However, there are conflicting reports.

Interventions

BIOLOGICALBlood sampling

Blood samples of 10 mL will be performed every 2 days from the first symptoms of CDI and until clinical recovery and/or hospital discharge

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Hospitalized * Suffering from diarrhea related to C. difficile * Confirmed diagnosis of CDI * Informed consent by the patient * Affiliated to the social security regime

Exclusion criteria

* Out-patient * No confirmed diagnosis of CDI * Decline of participation * Patient not affiliated to the social security regime

Design outcomes

Primary

MeasureTime frame
immune response rateup to 60 days after diagnosis

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026