Tag Archives: Gastrointestinal challenges

C. difficile Infection (CDI) Prevention, Treatment, Environmental Safety, Research, Clinical Trials Being Discussed with World Topic Experts On September 20th In Atlanta, Georgia USA

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September 20th

It is with great pride and certainty in the power of the healthcare community to present the 4th Annual International Raising. C. diff. Awareness Conference and Health Expo

being hosted at the

DoubleTree by Hilton — Atlanta Airport 
3400 Norman Berry Drive
Atlanta,Georgia 30344 USA  (Hotel Phone: 1-404-763-1600)

Doors open at 7:15 a.m — Sign In and Continental Breakfast

Conference begins at: 7:30 a.m. – 5:00 p.m.

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Raising C. difficile awareness is essential to build upon and advance existing knowledge and necessary for overcoming the challenges our healthcare communities are faced with today.

“None of us can do this alone — All of us can do this together”

Nearly half a million Americans suffered from Clostridium difficile (C. diff.) infections in a single year according to a study released February 25, 2015 by the Centers for Disease Control and Prevention (CDC).   C. diff. is a leading cause of infectious disease death worldwide; 29,000 died within 30 days of the initial diagnosis in the USA.   Previous studies indicate that C. diff. has become the most common microbial cause of healthcare-associated infections found in U.S. hospitals driving up costs to $4.8 billion each year in excess health care costs in acute care facilities alone.

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Cdiff2015-1Clinical professionals gather for one day to present up-to-date data to expand on the existing knowledge and raise awareness of the urgency focused on a Clostridium difficile infection (CDI) —

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

WITH

  • Microbiome research, studies
  • Infection Prevention
  • Fecal Microbiota Restoration and Transplants for Adults & Pediatrics
  • A Panel Of C. diff. Infection Survivors
  • Antibiotic Stewardship
  • Healthcare EXPO
    ……………………and much more.

You won’t want to miss out on this opportunity to learn from
International topic experts delivering data directed at evidence-based
prevention, treatments, and environmental safety in the C. diff.
and healthcare community.

Gain insights on September 20th that will not be available anywhere else with an opportunity to receive up-to-date data on major topics in this program being presented in one day.

5 Leading reasons to attend this dynamic conference:

  • Learn from leading healthcare professionals, clinicians, researchers, and industry.
  • Networking opportunities with new and reconnect with those in the healthcare community with similar interests.
  • Gain breakthrough results through research in progress and gaining positive results. Programs focused on Antibiotic-resistance such as the  Antibiotic Stewardship making a difference. Front line developments in progress focused on C. diff. infection prevention, treatments, environmental safety.
  • Implement and share the knowledge well after the conference ends.  Every attendee receives a booklet with guest speakers information, media to review audio programs, and Health Expo Sponsor information focused on the important agenda topics.
  • Embrace the opportunity, with all of the topic experts presenting, and hold the conference in the highest priority from the participation in this conference to an audience of medical students, and fellow healthcare professionals, who will benefit the most from the data and gain tools to overcome the barriers facing healthcare each day.

“The information and up-to-date studies shared at the 2015 conference added to an existing knowledge base that helps us to continue delivering quality care in the medical community.”   Linda Davis, RN,BSN

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REGISTRATION FEES:

$75.00  —  Conference Registration

$30.00  —  Student Conference Registration (Student ID To Be Presented At the Door)

TO REGISTER Click on the “Raising C. diff. Awareness” Ribbon below

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Room accommodations are available —  Complete and Confirm 

by August 19th to reserve your hotel reservations.   

To create a reservation please click on the DoubleTree By Hilton Logo below – – – – – –

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 A suggested travel coordinator, for your convenience

LibertyTraveldownloadMichael Beckman — Team Leader,  Liberty Travel, 467 Washington Street, Boston, MA  02111
617-936-2435
Michael.Beckman@flightcenter.com

 For Additional Information visit the C Diff Foundation Website:

https://cdifffoundation.org/

https://cdifffoundation.org/

And Click on the 2016 September Conference Tab

 

Follow us on Twitter
@cdiffFoundation
#Cdiff2016

Glenn Taylor, Head Microbiologist At the Taymount Clinic UK Discusses Fecal Microbiota Transplant (FMT) To Treat a Clostridium difficile Infection (CDI) on C diff Spores and More #CdiffRadio

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On Tuesday, March 8th  our guest, Glenn Taylor — Head Microbiologist –  joined us to discuss

“Taymount Clinic; Pioneering Fecal Microbiota Transplant ‘FMT’ For Digestive Problems”

CLICK ON THE Cdiff radio LOGO BELOW TO ACCESS THE PODCAST OF THIS EPISODE **

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Our guest, Glenn Taylor – Microbiologist at the Taymount Clinic just outside London in the UK, joined us to discuss this important topic.   Glenn has spent more than five years researching the commensal colonization of bacteria in the human digestive system. The Taymount Clinics are known internationally as a specialist center for the production of tested, certified, high quality gut bacteria and effective, efficient implant techniques Researching intestinal bacteria since 2006, the Taymount Clinic is now a recognized world leader in applying Fecal / Faecal Microbiota Transplant or FMT treatment procedures to create a “normal” bacterial environment in patients with a broad range of conditions. The Taymount clinic provides FMT treatment to normalize gut bacteria in patients with a Clostridium difficile infection.

For additional information visit the Taymount Clinic website:  www.taymount.com

C. diff. Spores and More™  Global Broadcasting Network –  producing educational programs dedicated to  C. difficile Infections and more —  brought to you by VoiceAmerica and sponsored by Clorox Healthcare

Fecal Transplants (FMT) Treating Clostridium difficile Infections; U.S. Food and Drug Administration (FDA) Seeks Comment on What Investigational New Drug (IND) Requirements To Waive

Fecal Transplants to Treat C. difficile: FDA Seeks Comment on What IND Requirements to Waive

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The US Food and Drug Administration (FDA) on Monday February 29, 2016,announced new draft guidance that aims to further assure that patients infected with the bacterium Clostridium difficile and not responding to standard therapies can access poop transplants, also known as fecal microbiota for transplantation (FMT).

FDA considers FMT an investigational new drug (IND), which requires physicians and scientists to file an IND application if they intend to use the treatment for clinical practice or research.

However, FDA has issued guidance stating that FMT may be used to treat 

C. difficile infection not responsive to standard therapies outside of a clinical trial. 

New Guidance

The latest draft guidance offers new notice that FDA intends to exercise enforcement discretion regarding the IND requirements for the use of FMT to treat C. difficile infection.

As far as what FDA wants to discuss on this new draft guidance, the agency says it’s requesting comments on which IND requirements are appropriate to waive.

In particular, FDA is requesting comments on the requirement for institutional review board review of the use of FMT to treat patients with C. difficile infection not responding to standard therapies when the FMT is provided by a stool bank,” FDA says.

Background

The draft guidance comes as over the past few years, FMT, which basically involves the transfer of a healthy donor stool to the bowel of a patient infected with C. difficile, has emerged as an effective means to treat recurrent forms of the bacterial infections, according to a study in the Journal of Law and Biosciences.

Rachel Sachs, an academic fellow at Harvard University’s Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics, and an author of that study, explained to Focus that previously FDA said it would regulate FMT like a biologic, but that the decentralized, hospital-based model of FMT envisioned in this new draft guidance more closely resembles the agency’s models for regulating tissue or cord blood products.

Two companies – Rebiotix and Seres Therapeutics – have been granted orphan drug designations for their INDs as FMT treatments for recurrent C. difficile infections, which affect between 85,000 and 110,000 people in the US annually.

And Sachs said she’s under the assumption that once a company gets FDA approval for their FMT product, FDA will revoke its enforcement discretion included in this new guidance.

Guidance Details

FDA said Monday it intends to use this discretion for waiving certain IND requirements, provided that:

  • The licensed health care provider treating the patient obtains consent from the patient or his or her legally authorized representative for the use of FMT products. The consent should include, at a minimum, a statement that the use of FMT products to treat C. difficile is investigational and a discussion of its reasonably foreseeable risks;
  • The FMT product is not obtained from a stool bank; and
  • The stool donor and stool are qualified by screening and testing performed under the direction of the licensed health care provider for the purpose of providing the FMT product for treatment of the patient.

And FDA makes clear that an establishment that collects or prepares FMT products “solely under the direction of licensed health care providers for the purpose of treating their patients (e.g., a hospital laboratory) is not considered to be a stool bank under this guidance.”

Sachs co-authored her article with Carolyn Edelstein, director of policy and global partnerships at OpenBiome, a nonprofit stool bank that sells FMT capsules (recommended dose of 30 capsules plus a safety test capsule costs $535, or stool preparations for delivery by colonoscopy, enema, and EGD/naso-enteric tube are $385 each) after conducting first-in-human evaluations (N=4) and a randomized dose-finding study (N=17).

Edelstein told Focus that the draft “suggests that the FDA is seeking to set up a more tailored regulatory scheme, one that considers stool banking separately from small-scale directed donation. We are in favor of seeing stool banking receive more regulatory oversight. We plan to answer the agency’s request for comments on the elements of a regulatory framework that would lend this oversight to the practice of stool banking without unduly burdening the physicians and healthcare facilities using banked material, and by extension, unduly limiting access to the treatment for their patients.”

FDA also explains that there were “difficulties in interpretation” with previous draft guidance, particularly around the provision that the donor be known either to the patient or to the treating licensed health care provider, noting “the revised approach more accurately reflects our intent to mitigate risk, based on the number of patients exposed to a particular donor or manufacturing practice rather than the risk inherent from any one donor.”

But as new FMTs are likely to hit the market as orphan drugs, the bigger issue at play could be associated with cost. Sachs noted that any FDA-approved treatment, particularly since it’s an orphan product, could be expensive (upwards of thousands of dollars for treatment).

 

Source:

http://www.raps.org/Regulatory-Focus/News/2016/02/29/24428/Fecal-Transplants-to-Treat-C-difficile-FDA-Seeks-Comment-on-What-IND-Requirements-to-Waive/

C. difficile infections With Challenging Nutritional Intake Imbalances; Malnutrition

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A C. difficile infection effects the gastrointestinal system.

What Is the Gastrointestinal System?
The human gastrointestinal system or GI tract, is an organ system responsible for consuming and digesting food, absorbing nutrients, and expelling waste (fecal matter).  The whole digestive tract is about nine meters (30 feet) in length. (1)

  1. Food enters through the mouth and is broken down by saliva and the act of chewing. It passes through the esophagus until it reaches the stomach.
  2. The stomach uses acids and enzymes to convert food into a semi-liquid state called chyme. The stomach then expels the chyme into the small intestine.
  3. The small intestine is the portal for all nutrients to enter into the bloodstream. Crucial digestive enzymes and hormones secreted from the pancreas, liver, and gallbladder break down the semi-liquid chyme into molecules small enough to be absorbed into the bloodstream.
  4. Any leftover food goes into the large intestine, where it is converted into solid waste with the help of bacteria. Water and salts are extracted from any undigested food. The end-product (fecal matter) is expelled through the rectum and anus.

Malnutrition may be broadly defined as nutritional imbalance.

More specifically, it has been defined by the American Academy of Nutrition and Dietetics as consisting of any two or more of the following:

  • Insufficient  intake
  • Weight loss
  • Loss of muscle mass
  • Loss of subcutaneous fat
  • Localized or generalized fluid accumulation that may mask weight loss
  • Diminished functional status as measured by hand-grip strength

(1) http://naturopathconnect.com

Patients who are nutritionally challenged and have subsequently restrict their diets to an excessive degree are at higher risk for micro-nutrient and macro-nutrient deficiency. Deficiencies can arise from altered nutrition and poor intake from many illnesses.

A Zinc deficiency may present with a rash that can resemble contact dermatitis or seborrheic dermatitis and can be best described as eczematous pink scaly plaques that may evolve into vesicular, bullous, pustular, or desquamative lesions. Patients with severe zinc deficiency will experience growth delay, mental slowing, poor wound healing, anemia, photophobia, hypogeusia, and anorexia. Zinc is an essential mineral required by the body for maintaining a sense of smell, keeping a healthy immune system, building proteins, triggering enzymes, and creating DNA. Zinc also helps the cells in your body communicate by functioning as a neurotransmitter. A deficiency in zinc can lead to stunted growth, diarrhea, impotence, hair loss, eye and skin lesions, impaired appetite, and depressed immunity. Conversely, consuming too much zinc can lead to nausea, vomiting, loss of appetite, abdominal cramps, diarrhea, and headaches in the short term, and can disrupt absorption of copper and iron in the long term. If you have a zinc deficiency, then animal foods are better sources of zinc than plant foods.  Main foods high in Zinc:  Lamb, Wheat-germ, Spinach, Pork, Chicken, Beans.

Vitamin C plays an important role in maintaining connective tissue by virtue of its effect on the hydroxylation of proline and lysine. Patients with scurvy are prone to easy bruising, hemorrhage, fatigue, weakness, and gingivitis. Treatment consists of oral repletion of vitamin C. Foods high in Vitamin C include bell peppers (yellow), dark leafy greens, kiwis, broccoli, berries, citrus fruits, tomatoes, peas, and papayas.

The elderly patients, and patients nutritionally challenged (e.g. C. diff. infections, IBS, Crohn’s, etc.) are at higher risks for developing protein engery malnutrition (PEM) as a consequence of several factors. One is from the inability to maintain adequate nutrition due to the symptoms created by  a C. difficile infection and other GI diagnosis.  Secondary is related to the loss of employment and wages resulting in the inability to acquire food and food products/supplements. Long-term poor nutrition can also result in poor oral health and dental problems which can also lead to difficulty in chewing.  There are many factors that can lead to malnutrition. * Discussing dietary challenges with a healthcare provider is important and asking for a dietary consult with a Registered Dietician is always helpful *  Protein is also essential for the healing of wounds. Accordingly, increasing this patient’s protein intake is a priority. A deficiency in protein leads to muscle atrophy, and impaired functioning of the human body in general. High protein foods include meat, fish, cheese, tofu, beans, eggs, lentils, yogurt, Not everybody needs the same amount of protein. (2) Protein servings of meat, poultry, or fish, should be the size and thickness of the palm of your hand, That’s about a 3-ounce portion. Meat eaters eat no more than two palm-sized servings of meat a day to get enough — but not too much — protein.  Patients with decreased kidney functions need to discuss dietary needs with their healthcare professional and referral/consult with a Registered Dietician for guidance.  To look at it another way, protein should take up no more than one-third of your plate at meals, whether it’s in a form you can drink or chew, Include small amounts of protein foods at every meal to spread your intake evenly throughout the day. (2)

(2) Wedmd.com

Malnutrition can also be diagnosed with a CT scan: A patient can be diagnosed with malnutrition from inflammatory bowel disease (IBD), with significant weight changes and altered bowel habits. In addition, the albumin level, if checked, will be low = malnutrition.

Physical findings that are associated with PEM (Protein – energy Malnutrition) include the following:

  • Decreased subcutaneous tissue: Areas that are most affected are the legs, arms, buttocks, and face
  • Edema: Areas that are most affected are the distal extremities and anasarca (generalized edema)
  • Oral changes: Cheilosis, angular stomatitis, and papillar atrophy
  • Abdominal findings: Abdominal distention secondary to poor abdominal musculature and hepatomegaly secondary to fatty infiltration
  • Skin changes: Dry, peeling skin with raw, exposed areas; hyperpigmented plaques over areas of trauma
  • Nail changes: Fissured or ridged nails
  • Hair changes: Thin, sparse, brittle hair that is easily pulled out

Protein Studies include:  Measures of protein nutritional status include levels of the following:

  • Serum albumin
  • Retinol-binding protein
  • Prealbumin
  • Transferrin
  • Creatinine
  • Blood urea nitrogen

* If a loved one or if you are nutritionally challenged at any time, from any illness, contact your healthcare provider as soon as possible and discuss the symptoms and complications associated with maintaining an adequate nutritional diet or hydration.  Clear liquid diets are ONLY for three days and Full Liquid diets are ONLY to be used during the direct healthcare provider supervision and frequent monitoring.

 

* The information provided on the website is for educational use only and not for physical or mental health assessment, diagnosis, or treatment for any illness or symptoms.  Please see disclaimer.  Always seek medical care and contact healthcare providers as soon as possible for full medical exams, diagnosis, and treatments. Thank you.