Royal Oak, MINCT07250724Now EnrollingIRB Ready

Clostridioides Difficile Infection Recurrence Clinical Trial in Royal Oak, MI

Access cutting-edge clostridioides difficile infection recurrence treatment through this clinical trial at a research site in Royal Oak. Study-provided care at no cost to qualified participants.

Sponsored by Bactolife A/S

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Expert Care in Royal Oak

Access clostridioides difficile infection recurrence specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related clostridioides difficile infection recurrence treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Royal Oak

    Convenient for MI residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Royal Oak site if eligible
  4. 4Begin participation

About This Clostridioides Difficile Infection Recurrence Study in Royal Oak

Hospitals and clinics interested in participating in this multi-site study, please contact the people mentioned under "Contacts and Locations". The goal of this study is to map the risk of having a C. Difficile infection recurrence (rCDI) after being treated with standard-of-care antibiotics for a C. Difficile infection. The main questions it aims to answer are: * What is the recurrence rate of CDI in the 8 weeks following antibiotic treatment for a first recurrence of CDI? * Does toxin levels of Toxin A and/or B from C. Diff. at baseline predict CDI recurrence risk? Participants will: * Undergo standard of care Antibiotic treatment for first recurrence of CDI * Visit their clinic at 4 different visits over a time period of approximately 9 weeks. (Visits can also be performed remote/via phone call.)

Sponsor: Bactolife A/S

Who Can Participate

Inclusion Criteria

Participants will be included in the study if they meet all of the following criteria At the time of screening:
Able to provide signed and dated informed consent
Males and females from the age of 18 and above
Planned or already ongoing SoC antibiotic treatment for diagnosed Clostridiodides difficile infection (CDI). All types of diagnosis/testing algorithms, and antibiotic taper regimes acceptable.
Documented history of, minimum one previous CDI episode occurring within the last 12 months. At the Time of Baseline Visit: \- Have completed the antibiotic treatment regime for the current CDI, a maximum of 5 days prior to the baseline visit Exclusion criteria Participants will be excluded from the study if they meet any of the following criteria: At the time of screening:
Planned CDI recurrence treatment for the planned 8-week duration of study participation (I.e., Fecal microbiome transplant, Rebyota, Vowst, Live Biotherapeutic Products (LBPs), probiotics etc)
Pregnant or lactating women or women who intend/wish to become pregnant in the time period in between screening and visit 4
Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results. I.e.: Ostomized participants, Parenteral nutrition users, Patients with active Pancreatitis, Active, non-controlled intestinal diseases such as IBS, IBD, Crohn's Disease, ulcerative colitis, celiac disease, or other chronic diarrheal illness
Currently or recently taking a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results.
Individuals who, in the opinion of the investigator, are considered to be poor study attendees or unlikely for any reason to be able to comply with the study.
Participants may not be participating in other clinical studies, or planning to do so during participating in the present study. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results. At the time of baseline visit:
Lack of CDI symptom resolution following the SoC antibiotic regime. I.e. still active diarrhoea (3 or more stools per 24-hour period) and within Bristol stool scale range of 5-7 at baseline.
Those who are on, or during study participation plan to go on, antibiotic treatment for any reason.

Exclusion Criteria

Participants will be excluded from the study if they meet any of the following criteria: At the time of screening:
Planned CDI recurrence treatment for the planned 8-week duration of study participation (I.e., Fecal microbiome transplant, Rebyota, Vowst, Live Biotherapeutic Products (LBPs), probiotics etc)
Pregnant or lactating women or women who intend/wish to become pregnant in the time period in between screening and visit 4
Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results. I.e.: Ostomized participants, Parenteral nutrition users, Patients with active Pancreatitis, Active, non-controlled intestinal diseases such as IBS, IBD, Crohn's Disease, ulcerative colitis, celiac disease, or other chronic diarrheal illness
Currently or recently taking a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results.
Individuals who, in the opinion of the investigator, are considered to be poor study attendees or unlikely for any reason to be able to comply with the study.
Participants may not be participating in other clinical studies, or planning to do so during participating in the present study. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results. At the time of baseline visit:
Lack of CDI symptom resolution following the SoC antibiotic regime. I.e. still active diarrhoea (3 or more stools per 24-hour period) and within Bristol stool scale range of 5-7 at baseline.
Those who are on, or during study participation plan to go on, antibiotic treatment for any reason.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Royal Oak?

Yes, this clinical trial (NCT07250724) has an active research site in Royal Oak, MI that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Clostridioides Difficile Infection Recurrence Treatment Options in Royal Oak, MI

If you're searching for clostridioides difficile infection recurrence treatment options in Royal Oak, MI, this clinical trial (NCT07250724) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Royal Oak research site is actively enrolling participants for this clinical trial. You'll receive care from experienced clostridioides difficile infection recurrence specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all clostridioides difficile infection recurrence clinical trials near you to find additional studies recruiting in your area.

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