Clostridioides difficile infection (C. diff) Clinical Trials

Help research new ways to help prevent C. diff

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Older gentleman experiencing stomach pain

Help research new ways to help prevent Clostridioides difficile infection (often called C. diff)

Early access to potential new treatments. Be among the first to benefit from medical advancements designed to improve

Expert medical care and monitoring. Receive ongoing support from leading healthcare professionals throughout the trial, ensuring your well-being at every step.

A key aim is to understand whether an investigational medicine can help reduce flare-ups (also known as exacerbations), which are sudden worsening of symptoms that can lead to hospital visits.

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c diff clinical trial - Older gentleman experiencing discomfort

What to expect on your visit

Warm welcome and check in

Our team will will greet you and guide you though the process.

Comfortable waiting area

Relax with seating, refreshments and Wi-Fi whilst you wait.

Meet your specialist

A dedicated professional will explain everything and answer any questions.

Clear instructions

We’ll walk you through each step so you know exactly what to expect

Time for questions

You’ll have the opportunity to ask anything about your participation

Follow-up guidance

We’ll provide details on the next steps and any necessary follow-up visits.

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Your questions answered

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A clinical trial protocol is a comprehensive plan that outlines the study’s objectives, design, methodology, statistical considerations, and organisation. It specifies:
- The purpose of the study
- Eligibility criteria for participants
- Details of tests, procedures, medications, and dosages
- The schedule of activities
- Information to be collected about participants
This protocol ensures the study is conducted consistently and safely across all participants.
What is a clinical trial protocol?

A clinical trial protocol is a comprehensive plan that outlines the study’s objectives, design, methodology, statistical considerations, and organisation. It specifies:

The purpose of the study

Eligibility criteria for participants

Details of tests, procedures, medications, and dosages

The schedule of activities

Information to be collected about participants

This protocol ensures the study is conducted consistently and safely across all participants.
Clinical trials encompass various study types, including:
- Prevention Trials: Explore methods to prevent diseases in individuals who have not had them or to prevent recurrence.
- Treatment Trials: Test new treatments, drug combinations, or approaches to therapy.
- Diagnostic Trials: Seek better tests or procedures for diagnosing specific conditions.
- Screening Trials: Evaluate ways to detect diseases or health conditions.
- Quality of Life Trials: Aim to improve comfort and life quality for individuals with chronic illnesses.
Many trials compare a new product or therapy to existing treatments or placebos to determine effectiveness. Potential participants are informed beforehand if placebos are part of the study design.
What types of clinical trials are available?

Clinical trials encompass various study types, including:

Prevention Trials: Explore methods to prevent diseases in individuals who have not had them or to prevent recurrence.

Treatment Trials: Test new treatments, drug combinations, or approaches to therapy.

Diagnostic Trials: Seek better tests or procedures for diagnosing specific conditions.

Screening Trials: Evaluate ways to detect diseases or health conditions.

Quality of Life Trials: Aim to improve comfort and life quality for individuals with chronic illnesses.

Many trials compare a new product or therapy to existing treatments or placebos to determine effectiveness. Potential participants are informed beforehand if placebos are part of the study design.
Participating in a clinical trial offers several potential benefits:
- Access to New Treatments: You may receive investigational therapies not yet available to the public, potentially improving your health condition.
- Contribute to Medical Research: Your involvement aids in understanding how treatments work across different populations, helping to develop better therapies for future patients.
- Comprehensive Care: Participants receive close monitoring and additional healthcare assessments related to the study.
- Voluntary Participation: You can withdraw from the study at any time without any obligation.
Each study has specific eligibility criteria, so not everyone who applies will be accepted.
Why should I participate in a clinical trial?

Participating in a clinical trial offers several potential benefits:

Access to New Treatments: You may receive investigational therapies not yet available to the public, potentially improving your health condition.

Contribute to Medical Research: Your involvement aids in understanding how treatments work across different populations, helping to develop better therapies for future patients.

Comprehensive Care: Participants receive close monitoring and additional healthcare assessments related to the study.

Voluntary Participation: You can withdraw from the study at any time without any obligation.

Each study has specific eligibility criteria, so not everyone who applies will be accepted.
Clinical trials progress through several phases, each designed to answer specific research questions:
- Phase 1: Involves a small group (20-80 participants), often healthy volunteers or patients with advanced diseases. The focus is on evaluating safety, identifying side effects, determining safe dosage ranges, and understanding how the body processes the investigational product. This phase typically lasts several months, with about 70% of studies advancing to Phase 2.
- Phase 2: Enrols 100-300 participants with the condition under study to further assess safety and effectiveness. These trials may be randomised and controlled, comparing the investigational product to standard treatments or placebos. Blinding is often used to prevent bias. Phase 2 studies usually take up to two years, with approximately 33% progressing to Phase 3.
- Phase 3: Includes larger groups (thousands of participants) to confirm effectiveness, monitor side effects, and compare the investigational product to standard treatments. These randomised and blinded trials can last from one to four years, with 25-30% successfully leading to regulatory approval submissions.
- Phase 4: Conducted after regulatory approval, these post-marketing studies gather additional information on risks, benefits, and optimal use in various populations over extended periods. Findings can influence whether a product remains on the market or if usage guidelines need adjustments.
What do the different phases of a clinical trial mean?

Clinical trials progress through several phases, each designed to answer specific research questions:

Phase 1: Involves a small group (20-80 participants), often healthy volunteers or patients with advanced diseases. The focus is on evaluating safety, identifying side effects, determining safe dosage ranges, and understanding how the body processes the investigational product. This phase typically lasts several months, with about 70% of studies advancing to Phase 2.

Phase 2: Enrols 100-300 participants with the condition under study to further assess safety and effectiveness. These trials may be randomised and controlled, comparing the investigational product to standard treatments or placebos. Blinding is often used to prevent bias. Phase 2 studies usually take up to two years, with approximately 33% progressing to Phase 3.

Phase 3: Includes larger groups (thousands of participants) to confirm effectiveness, monitor side effects, and compare the investigational product to standard treatments. These randomised and blinded trials can last from one to four years, with 25-30% successfully leading to regulatory approval submissions.

Phase 4: Conducted after regulatory approval, these post-marketing studies gather additional information on risks, benefits, and optimal use in various populations over extended periods. Findings can influence whether a product remains on the market or if usage guidelines need adjustments.
A clinical trial is a medical research study involving volunteers to explore new ways to prevent, detect, or treat diseases, illnesses or ailments. These studies assess investigational treatments, which may include new drugs, combinations of drugs, new delivery methods for existing medications, or medical devices. Before approval, these treatments undergo rigorous testing to ensure they are safe and effective. Each trial follows a detailed protocol outlining the study’s purpose, participant criteria, procedures, and duration. A principal investigator, often a medical doctor, leads the research team, which includes various healthcare professionals. Participation is entirely voluntary, and diverse involvement is crucial to understand different responses to the investigational product.

What is a clinical trial?

A clinical trial is a medical research study involving volunteers to explore new ways to prevent, detect, or treat diseases, illnesses or ailments. These studies assess investigational treatments, which may include new drugs, combinations of drugs, new delivery methods for existing medications, or medical devices. Before approval, these treatments undergo rigorous testing to ensure they are safe and effective. Each trial follows a detailed protocol outlining the study’s purpose, participant criteria, procedures, and duration. A principal investigator, often a medical doctor, leads the research team, which includes various healthcare professionals. Participation is entirely voluntary, and diverse involvement is crucial to understand different responses to the investigational product.

Trial details overview

What’s this clinical trial about?

Clostridioides difficile infection (often called C. diff) is one of the most common healthcare-associated infections worldwide. Commonly referred to as a ‘tummy bug’, it’s highly contagious and can cause diarrhoea, colitis (inflammation of the bowel), stomach pain, fever, nausea, and vomiting.

This clinical trial is testing a potential C. diff vaccine in adults aged 65 years and older. The study will look at how well the vaccine is tolerated, and whether it may protect people from future infections.

By taking part, you’ll be contributing to research that could help protect others from this difficult-to-treat infection.

Trial Details

You’ll attend 5 clinic visits over the course of the study
Participants will receive travel reimbursement and financial compensation for their time
The trial is designed with your comfort and safety in mind
Most importantly, you’ll be helping advance research into a vaccine that could protect vulnerable people from C. diff

Who Can Join?

You may be able to take part if you:

Are 65 years or older
Have a higher risk of C. diff infection due to:

- A hospital stay of more than 2 nights in the past 12 months, or
- 2 or more emergency room visits in the past 12 months, or
- At least 10 outpatient visits (primary and/or secondary care visits; defined as an in-person visit to the office/clinic of a prescribing healthcare provider for the purposes of the diagnosis, treatment, or ongoing management of a medical conditions, excluding pharmacy, dental, and mental health visits) in the previous 12 months; or
- Antibiotics (oral or injected) for more than 48 hours in the past 12 weeks.
- Participants who have a planned inpatient hospitalization for more than 2 nights’ duration or elective surgery of any duration scheduled more than14 days after receipt of a vaccination.