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NCT07250724 · Bactolife A/S

C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.

What this study is about

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.

View original scientific description

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.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

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.

Where

  • Atlanta, Georgia
  • Royal Oak, Michigan
  • Rochester, Minnesota
  • Madison, Wisconsin

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Jun 15, 2026 · Source of record for eligibility and locations

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1 of 60 participants interested
2% interest

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Study locations

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Remote participation via telemedicine and home visits

RECRUITING

Atlanta

Georgia

Location available
RECRUITING

Royal Oak

Michigan

Location available
RECRUITING

Rochester

Minnesota

Location available
RECRUITING

Madison

Wisconsin

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

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Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Clostridioides Difficile Infection Recurrence Treatment in Atlanta?

Join others in Georgia exploring innovative treatment options through clinical research

Clostridioides Difficile Infection Recurrence Treatment Options in Atlanta, Georgia

If you're searching for Clostridioides Difficile Infection Recurrence treatment in Atlanta, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Atlanta, Royal Oak, Rochester and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Clostridioides Difficile Infection Recurrence. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Georgia
Now Enrolling
Up to 60 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Clostridioides Difficile Infection Recurrence?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Clostridioides Difficile Infection Recurrence

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Clostridioides Difficile Infection Recurrence Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT07250724. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.