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Tiny study aims to improve c. diff sample collection

NCT ID NCT06277999

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

7 people

The number who actually took part.

Started

Apr 2024

Finished

Dec 2024

Lead sponsor

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

18 to 130 years

Sex

Anyone

Healthy volunteers

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

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

  • Research Site

    Sacramento, California, 95817, United States

  • Research Site

    Hamden, Connecticut, 06518, United States

  • Research Site

    Boston, Massachusetts, 02114, United States

  • Research Site

    Boston, Massachusetts, 02115, United States

  • Research Site

    St Louis, Missouri, 63110, United States

  • Research Site

    Charleston, South Carolina, 29425, United States

  • Research Site

    Charlottesville, Virginia, 22903, United States

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