what is c.diff?
Clostridium difficile Infection, also called C. Diff. is caused when an infectious pathogen enters the colon. C. Diff can go away on its own, but those previously affected often carry bacterial spores that heighten their chance of C. Diff. recurrence. This is called recurrent C. Diff. (rCDI) and is a significant medical condition for many people. In most cases C. Diff. is treated with antibiotics.
Symptoms of C.Diff may include:
• Diarrhea
• Abdominal pain
• Bloating
• Dehydration
• Fever
about the study
This study is testing the safety and effectiveness of an experimental drug called VE303 compared to a placebo (a capsule containing no VE303), at keeping rCDI from returning. VE303 is a preparation of eight different types of bacteria grown in clean conditions, dried, powdered and put into capsules. The bacteria are reactivated once they reach your intestines. In contrast to fecal transplants, which rely on direct sourcing of fecal donor material of inconsistent composition, VE303 is manufactured from pure cell banks that yield a product of uniform composition, free of viruses and uncharacterized bacteria.
An experimental drug is a drug that has been approved by the Food and Drug Administration (FDA) to be tested further in a population of volunteers. Preclinical data and a previous study in healthy volunteers suggest that VE303 may help reestablish resistance against C. diff by accelerating restoration of the gut microbiota from perturbations caused by antibiotics. The safety study of VE303, showed that the doses we are using in this study were safe and well tolerated in healthy volunteers.
Additional study requirements will be discussed with a study representative.
QUALIFIED PARTICIPANTS, WILL RECEIVE:
• Study related medications.
• Appointments and examinations at no cost.
Health insurance is not required to participate.
TO PRE-QUALIFY YOU MUST:
• Have experienced 2 or more episodes of C. Diff. Infection
with at least 1 of those episodes occuring within the past 6 months.
• Be 18 years of age or older.
For More information on C. Diffcile we recommend reading the Center for Disease controls (CDC) page on C. Diff. https://www.cdc.gov/cdiff/index.html
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Medical equipment services are available for those who qualify for specific trials.
ONLINE CONTACT
Fill out the contact form below and we will contact you regarding participating in this trial opportunity.
What is the Next Step?
If interested, contact us to learn more about this study. Our medical professionals will be happy to answer all of your questions about participation.
This facility and staff and doctors. Helped me so much. I in my heart feel that I would not be here today. Love you all. Thank you all from the bottom of my heart. Love always.
Dr’s Trevino and Little are thorough attentive and concerned. Innovative Research of West Florida have some great studies you can involve yourself in if are looking for solutions to some of your medical questions such as COPD and others. They will take great care of you and the staff is very attentive and considerate.
Our staff is here to answer your questions about clinical trials opportunities. These clinical trials are only open for enrollment for limited times so make sure to contact us.
A clinical research study tests the safety and efficacy of an investigation medicine or treatment in a population of volunteers. Every medical discovery/breakthrough goes through the clinical trial process, so potential participants like you play a very important role in advancing medicine for present and future generations.
The study drug is an investigation product. You may or may not benefit from the study drug.
Protecting the health and safety of people who take part in clinical trials is the highest priority for clinical researchers. All clinical trials must follow strict federal guidelines on how volunteer must be treated throughout the entire study process.
You have the right to leave a clinical trial at anytime and for any reason. If you decide to leave a trial, talk to your doctor first. You will want to know how leaving the trial may affect your health and what other treatment options may be available.
