Tiny study aims to improve c. diff sample collection
NCT ID NCT06277999
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how well stool and blood samples could be collected from 7 adults with an active C. diff infection. Researchers wanted to see if the collection, shipping, and testing methods worked smoothly. Participants also filled out questionnaires about their symptoms. The goal was to improve how samples are gathered for future C. diff research.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could help researchers develop better ways to collect and test samples from people with C. diff infections, making future studies more efficient.
- What could go wrong
- This was a very small study (only 7 people) and was only about testing sample collection methods, not about finding a treatment. Results may not apply to larger or more diverse groups.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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7 people
The number who actually took part.
- Started
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Apr 2024
- Finished
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Dec 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
≥ 18 Years of Age (Adult, Older Adult )
- Ages
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18 to 130 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female participants ≥ 18 years of age at the time of signing the informed consent 2. Participants in the Monitoring and Discard Stool cohorts with an active treated CDI, defined as meeting all of the following: * Prior to or at diagnosis of C. difficile, either diarrhea, defined as ≥ 3 unformed stools in a 24 hour period, with the stool being measured as Types 5, 6, 7 on the Bristol Stool Scale or evidence of megacolon, or severe ileus. * A positive local stool test results for toxigenic C difficile collected before entry to the study or evidence of pseudomembranes demonstrated by endoscopy or histopathology. For the Monitoring Cohort - positive test result immediately prior to start of or during SOC treatment. For the Discard Stool Cohort - no more than 7 days prior to entry to the study. * Stool test positive for only GDH or PCR and negative for toxin, provided there is observed clinical improvement noted by the Investigator within 5 days of start of SOC treatment, characterized by a reduction in diarrhea , in the the judgement of the Investigator * Receiving SOC therapy for the treatment of CDI at the time of enrollment. 3. Able to complete all study assessments, and to understand and comply with study requirements/procedures (if applicable, with assistance by caregiver, surrogate, or legally authorized representative, or equivalent representative as locally defined) based on the assessment of the PI 4. Able to complete the Follow-up period through Day 42 based on the assessment of the PI. 5. If able, signed and dated written informed consent prior to any study specific procedures, including screening evaluations for participants who consent to participate in the Monitoring cohort. Ensure that participants who are considered by the Investigator clinically unable to consent at screening and who are entered into the study by the consent of a legally acceptable representative show evidence of assent, as applicable in accordance with local regulations. 6. Signed and dated written information consent prior to collection and testing of stool samples for participants in the Discard Stool cohort Exclusion Criteria: 1. Employees of AstraZeneca, clinical study site, or any other individuals directly involved with the conduct of the study, or immediate family members of such individuals. Employees of the clinical site or immediate families of these individuals not directly involved in the clinical study will be permitted to participate. 2. Deprived of freedom by an administrative or court order, or in emergency setting, or hospitalized involuntarily 3. Absence of suitable venous access for serum sampling
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research Site
Sacramento, California, 95817, United States
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Research Site
Hamden, Connecticut, 06518, United States
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Research Site
Boston, Massachusetts, 02114, United States
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Research Site
Boston, Massachusetts, 02115, United States
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Research Site
St Louis, Missouri, 63110, United States
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Research Site
Charleston, South Carolina, 29425, United States
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Research Site
Charlottesville, Virginia, 22903, United States
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Other studies related to the condition(s) this trial covers.
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