Category Archives: Clinical Trials

C. diff. Spores and More Live Broadcast to Podcast Is Available: Prevent CDI: Boost Immunity, Restore Microbiome, Replace the Bug

 

We are pleased to share  “C. diff. Spores and More ”  with you because, as advocates of  C. diff.,  we know the importance of this cutting-edge new weekly radio show and what it means for our Foundation’s community worldwide.

 

 

July 20, 2021:  Prevent CDI: Boost Immunity, Restore Microbiome, Replace the Bug

With Guests:

Neil Clark, Chief Executive Officer, Destiny Pharma, PLC

Mr. Clark qualified as an accountant with PwC in Cambridge, UK and worked for over ten years on a variety of national and international assignments in audit, corporate finance and consultancy. In 1997, Mr Clark joined CeNeS Pharmaceuticals plc, a venture capital backed private UK biotech company. Following the successful flotation of CeNeS in 1999, he was appointed CFO. In 2005, he became CEO and led the company through to its sale in 2008. He then joined Ergomed in January 2009 and was CFO during its IPO in July 2014. Mr. Clark joined Destiny Pharma as CEO in early 2017. Mr. Clark is a Fellow of the Institute of Chartered Accountants in England and Wales and has a BSc in Bioscience from the University of Nottingham.

Dale Gerding, MD, FACP, FIDSA, FSHEA

Dr. Dale Gerding is Research Physician at the Edward Hines Jr. VA Hospital and Professor of Medicine (Retired) at Loyola University Chicago Stritch School of Medicine. He is an infectious diseases specialist and hospital epidemiologist, past president of the Society for Healthcare Epidemiology of America. He is a fellow of the Infectious Diseases Society of America, is a Master of the American College of Physicians and the 2013 recipient of the William Middleton Award, the highest research award given by the Department of Veterans Affairs. He is board certified in Internal Medicine and Infectious Diseases. His major research interest is in the epidemiology, prevention and treatment of Clostridioides difficile infection and he is the discoverer of non-toxigenic C. difficile strain M3. (NTCD-M3)

https://www.voiceamerica.com/episode/132305/prevent-cdi-boost-immunity-restore-microbiome-replace-the-bug

Neil Clark, Chief Executive Officer, Destiny Pharma PLC and Dale Gerding, MD, FACP, FIDSA, FSHEA, with our Guest Host: Kevin Hersh, shared a robust discussion which touched upon important topics focused on the what, why, and how to Prevent a C. diff. infection: Boost Immunity, Restore Microbiome, Replace the Bug. Our guests exchanged a dialogue about the science to answer the many questions about a C. difficile infection, prevention, treatments, what is recurrent C. diff., and the immune system, and how the microbiome plays a part in everything.  Click on the link provided above to access the archived episode and expand your basic CDI knowledge today.

In-Home Enrollment Of Randomized Controlled Trials Finds To Be An Innovative Method Improving Access To Clinical Research

Abstract

Introduction: Clostridioides difficile infection is the leading cause of infectious diarrhea in the United States, with substantial morbidity and mortality. Recurrent infection is especially challenging, with each recurrence increasing the likelihood of a successive recurrence, leading to cycles of prolonged symptoms, frequent antimicrobial use, and decreased quality of life. Fecal microbiota transplantation to prevent recurrent infection is a promising intervention with a large effect size in observational studies, but with conflicting results from randomized controlled trials. We are conducting a Veterans Affairs-wide randomized controlled trial utilizing centralized case identification, with enrollment and fecal microbiota transplant administration occurring at the participant’s home. This type of trial design significantly improves trial efficiency, greatly decreases trial cost, increases consistency of trial administration, and most importantly makes nationwide clinical trials in less-common diseases possible.

Methods: This is a randomized comparison of capsule-delivered fecal microbiota transplant for the prevention of recurrent Clostridioides difficile infection, administered after successful initial treatment of recurrent C. difficile infection with standard therapy. The primary endpoint is the incidence of recurrent C. difficile infection or death. Cases are identified by searching the Veterans Affairs Corporate Data Warehouse, with central study coordinators then reaching out to potential participants. Individuals meeting inclusion criteria and interested in participation are scheduled for in-home consent, randomization, and capsule administration, followed by telephone follow-up for 6 months. To mitigate risks of COVID-19, enrollment via video visits has been implemented.

Results: A total of 102 participants have been enrolled through January 2021. Centralized case identification and in-home enrollment has facilitated enrollment from 34 unique states, with 38% being from rural or highly rural areas.

Discussion: Centralized case identification and in-home enrollment is a feasible and innovative method of conducting randomized controlled trials in the Veterans Affairs system, improving access to clinical research for populations who may have difficulty engaging with the traditional model of clinical trials where enrollment is based at large hospitals in major metropolitan areas.

Keywords: Fecal microbiota transplant; centralized enrollment; Clostridioides difficile; diarrhea; randomization; recurrence; stool transplant.

source:  https://pubmed.ncbi.nlm.nih.gov/34154439/

Dale Gerding, MD, FACP, FIDSA, FSHEA To Chair the July 16, 2021 C. diff. Patient, Family, and Caregiver Live-Online Symposium

Scientific Advisor Prof Dale Gerding to chair C. diff. Foundation

C. diff. Patient, Family, and Caregiver Symposium

July 16th  – Live-Online beginning at 1:00 p.m. – 3:00 p.m. EDT 

Register Today!

 

 

 

 

Brighton, United Kingdom – 02 July 2021 – Destiny Pharma plc (AIM: DEST), a clinical stage innovative biotechnology company focused on the development of novel medicines to prevent life-threatening infections, is pleased to announce that its Scientific Advisory Board member, Professor Dale Gerding, a world-leading expert in C. difficile infections (CDI) and the discoverer of NTCD-M3, will be chairing the “C. diff. Patient, Family, and Caregiver” Symposium, to be held virtually on 16 July 2021.

The Symposium, hosted by the C Diff Foundation, will be a gathering of healthcare professionals, practitioners, thought leaders, and C. diff. survivors focused on transforming the patient experience of people living with C. diff. infections worldwide.

Distinguished members and keynote speakers will provide insight on how to identify, evaluate, and prioritize innovations that can quickly touch the lives of patients battling C. diff. infections.

Destiny Pharma’s late-stage asset, NTCD-M3, is a novel microbiome therapeutic being developed to reduce the recurrence of C. diff. infections in the gut. CDI is the leading cause of hospital acquired infection in the US and current treatments lead to significant recurrence. In the US, there are approximately 500,000 cases of CDI each year; many of these initial cases then recur leading to 29,000 deaths per year.

NTCD-M3 has the potential to become the leading treatment for CDI, as it has shown to deliver clear advantages to both existing CDI treatment options and also to those currently in clinical development.

About Destiny Pharma plc
Destiny Pharma is a UK based, clinical stage, innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections. Its pipeline has novel microbiome-based biotherapeutics and XF drug clinical assets including NTCD-M3, a Phase 3 ready treatment for the prevention of C. difficile infection (CDI) recurrence, which is the leading cause of hospital acquired infection in the US and also XF-73 nasal gel, which has recently completed a positive Phase 2b clinical trial targeting the prevention of post-surgical staphylococcal hospital infections including MRSA. It is also co-developing SPOR-COV, a novel, biotherapeutic product for the prevention of COVID-19 and other viral respiratory infections, and has earlier grant funded XF research projects. 

Patient, Family, Caregiver January Symposium Broadcasts During March On C. diff. Spores and More Live Program

CDIFFRADIO.COM

 

 

 

 

 

 

 

SAVE THE DATES to listen in to the leading topic expert presentations

shared on January 15, 2021, at the Patient, Family, Caregiver Symposium:

Beginning Tuesday, March 9 from 1:00 p.m. – 2:00 p.m. EST following through on

March 16,  March 23, and  March 30.

A Symposium specifically developed for Patients Diagnosed With a C. diff. Infection, Being Treated For a Clostridioides diffiicile infection, Recovering From a Clostridioides difficile Infection and Recurrences with Family Members and Caregivers.

The Patient & Family C. diff. Symposium was a gathering of healthcare professionals, keynote speakers, health advocates, practitioners, educators, thought leaders, and patients who are transforming the patient experience and changing the way people experience
C. diff. infections worldwide.

Unlike other conferences on this topic, patients will share their C. diff. infection journeys, providing a real-world perspective on patient experience. Our attendees will learn more from this virtual-online symposium and gain knowledge on important topics that will better aid their care and recovery through tools and strategies delivered by keynote speakers.  

The Symposium followed the C Diff Foundation Mission statement –   Educating and Advocating for the prevention, treatments, clinical trials, diagnostics, and environmental safety of Clostridioides difficile
(C. diff.) infections worldwide.

Keynote speakers presented up-to-date data to expand on the existing knowledge and provide important information focused on, yet not limited to,  a Clostridioides difficile infection (also known as C. diff., C. difficile, CDAD, CDI) ……

  • Prevention
  • Treatments
  • Diagnostics
  • Research
  • Environmental Safety
  • Clinical trials and studies

WITH

  • Introduction to Microbiome Research and Studies
  • Infection Prevention
  • Fecal Microbiota Restoration and Transplants
  • Antibiotic Stewardship

We hope you enjoy the broadcasts!

 

Program Chair:  Paul Feuerstadt, MD, FACG

Barbara McGovern, MD     “Treatment of recurrent C. difficile infection with                                                                                        SER-109, an investigational microbiome drug.”

Paul Feuerstadt, MD          ” C. diff. Overview – What is a C. diff. Infection?”

Sahil Khanna, MD               “C. diff. Treatments + FMT Overview. “

 

 

 

Simon Cutting, Ph. D.         “Bacillus, and C. diff.  Spore Overview. “

Teena Chopra, MD                ” Introduction to Infection Prevention.”

Doe Kley, RN, MPH              “C. diff. Transitioning from Hospital to Home. “

Courtney Jones                    ” Microbiome, Microbiota, and Gut Health.”

Denise Cardo, MD                “Everyone Has a Role in Antibiotic Awareness.”

Larry Kociolek, MD              “C. diff. Infections in Pediatrics.”

Kathy Bischoff                        “My C. diff.  Journey.”

Renata Johnson                      “My C. diff. Journey.”

Paul Feuerstadt, MD      &    Barbara McGovern, MD

 

This Symposium was hosted by the C Diff Foundation and

Sponsored by Seres Therapeutics  

Please — Do Not Take Medicine Into Your Own Hands, You Are NOT Out Of Options

Do-It-Yourself Treatments Could Be Fatal……

You are NOT out of options………………………

During these unprecedented times, we understand the patient’s frustration and how this pandemic has created a halt to the readily accessible alternative treatment option in the FMT community.   The need for continued treatments for a C. diff. infection and recurrent C. diff. infections are real and necessary. We also understand how patients experiencing
recurrent C. difficile infections are desperately seeking the FMT alternative treatment.

C Diff Foundation is able to provide information about treatments available to safely treat  CDI’s and recurrent C. diff. infections.

Most home remedies or natural therapies, though, haven’t been put through the same rigorous clinical testing you expect from pharmaceutical medications.

In a world where you can fix almost anything with a do-it-yourself video on YouTube, you might think curing your own illness would be a piece of cake. It might be if it weren’t for a couple of (not so small) sticking points.  One, the home remedy recommended by your friend — or one of the many websites promoting “natural therapies” — might not work.1  Dr. Harriet Hall, a retired family physician, former Air Force flight surgeon, and author of the SkepDoc column in Skeptic magazine, is one of those leading the charge against medical “treatments” not supported by science.  Like others in the medical and scientific community, ……. There is the only medicine that has been tested and proven to work, and medicine that hasn’t,” Hall told Healthline. 1

Talk to your medical professional/s.

Discuss medications and clinical trials available.

Do Not Share Antibiotics.

Responses to an anonymous online questionnaire of 496 parents, researchers at the Cohen Children’s Medical Center of New York reported that 48 percent of the parents surveyed said they’ve held onto leftover antibiotics. More troubling to researchers was that of those parents, 73 percent reported giving those antibiotics to siblings, unrelated children, and unrelated adults.  This would sometimes occur months after the drugs were originally prescribed.
Dr. Ruth Milanaik, director of the neonatal neurodevelopment follow-up program at Cohen and senior author of the study, says the results show an “alarming” percentage of parents engaging in sharing or borrowing antibiotics, a practice known as prescription diversion.  “This is dangerous not only for those given antibiotics that weren’t prescribed for them but for entire populations of people who some antibiotics may no longer help when the bacteria they target become resistant to them,” Milanaik said in a statement. 2

Discuss Resources available.

Times are trying during these unprecedented times and you are not without hope – we would like to help you and not see you get hurt or even worse. Please take time to speak to your treating physician and consider contacting a C Diff Foundation Triage Nurse at 727-205-3922 to learn more about safe and effective treatments available and options available to you at this time of desperation.

Remember – You  Are Not Out of Options.

Stay safe – and please – Do NOT take medicine into your own hands.

Thank You!

Resources:
1 Foxnews.com
2 Healthline.com