Study paves the way for Clostridium difficile treatment in pill form

March 14, 2017 by Hannah Rhodes
Study authors Zhi-Dong Jiang, M.D., Dr.P.H., and Herbert DuPont, M.D. Credit: Terry Vine

Frozen and freeze-dried products for Fecal Microbiota Transplantation (FMT) are nearly as effective as fresh product at treating patients with Clostridium difficile (C-diff) infection, according to researchers at The University of Texas Health Science Center at Houston (UTHealth) School of Public Health and Kelsey Research Foundation. A new study, which proves that a pill form of treatment could be effective and more convenient for patients and physicians, was published in the most recent issue of Alimentary Pharmacology & Therapeutics.

C-diff is a bacterium that causes inflammation of the colon. People infected with the bacteria can have recurrent diarrhea that lasts months or even years. It is the No. 1 hospital-acquired infection in the United States and leads to 29,000 deaths each year, according to the Centers for Disease Control and Prevention. The illness most commonly affects people in hospitals and nursing homes who are taking antibiotics and may have an underlying medical condition.

FMT is a procedure in which a doctor extracts bacteria from fecal matter from a healthy donor, mixes the bacteria in a solution and transfers the microbiota to a person with C-diff via colonoscopy, endoscopy, sigmoidoscopy or enema. The study shows that the fecal microbiota can be frozen or freeze-dried (like instant coffee). The procedure replenishes good bacteria killed by antibiotics in the microbiome.

For the study, UTHealth and Kelsey Research Foundation investigators enrolled 72 patients who had at least three bouts of recurrent C-diff in a clinical trial and treated them with either fresh, frozen or freeze-dried FMT product via colonoscopy. Fresh FMT product produced a 100 percent cure rate among participants; frozen product produced an 83 percent cure rate and freeze-dried product produced a 69 percent cure rate.

Frozen and fresh product fully restored the microbiota diversity among participants within seven days after treatment. Researchers saw some improvement in microbiota diversity among participants treated with freeze-dried product after seven days and full restoration of healthy bacteria within 30 days.

"This is the first study to show that frozen and freeze-dried microbiota are as good as fresh material, so that we never have to use fresh again. It's a logistical nightmare to use fresh product. If we were going to treat you today, a donor would have come in two hours before, we would have already isolated the sample and then we would have to administer it the same day. A pill form of the product could make all of this easier," said Herbert L. DuPont, M.D., senior author and director of the Center for Infectious Diseases at UTHealth School of Public Health.

DuPont co-directs the FMT program with Zhi-Dong Jiang, M.D., Dr.P.H., associate professor in the Department of Epidemiology, Human Genetics and Environmental Sciences at the School of Public Health. DuPont is also the president and CEO of Kelsey Research Foundation.

"Freeze-dried product can be put into a pill that can be given orally, which is much more convenient for patients and physicians," said DuPont, who is currently testing the safety and efficacy of a pill version of the product.

One of the participants in the clinical trial, John Siebert, was on vacation with his family in California when he contracted C-diff in August 2014. The 66-year-old, who is a professor of agricultural economics at Texas A&M University, sought medical care as soon as he returned to Texas but was stunned that his doctors did not know how to treat the condition in a lasting way. After four months and three bouts of C-diff that left him fighting for his life, Siebert was at a loss.

"It's extremely painful and debilitating because you can't ever really be far from a bathroom. I had really bad cramps and I ate a lot less because I didn't want to aggravate things," said Siebert, who lost nearly 20 pounds and missed a month of work.

Eventually, Siebert found DuPont and Jiang, who were enrolling patients in their FMT clinical trial. Siebert immediately signed up and had the procedure done in early December. Siebert felt mostly recovered by Christmas and was back to his normal self by March 2015.

"It was a miracle! I love teaching and I can't tell you what it was like to be healthy again, to be able to do my job and not retire before I was ready," said Siebert.

Siebert's struggle to find a permanent cure to C-diff is not uncommon. Physicians typically treat C-diff with antibiotics, which can kill one form of the bacteria, the toxins. However, C-diff spores are much harder to kill and once the antibiotics have destroyed both good and bad bacteria in the gut, the remaining spores can release additional toxins. There is a 50 percent chance that a person who has C-diff will get a recurrent infection because of those toxins.

Explore further: Single fecal transplant no more effective than standard of care in treating C. diff

Related Stories

Single fecal transplant no more effective than standard of care in treating C. diff

January 4, 2017
Researchers at the University Health Network have found that when treating recurrent Clostridium difficile infection (RCDI), a single fecal transplantation delivered by enema is no more effective than the existing standard ...

New C. diff treatment reduces recurrent infections by 40 percent

January 25, 2017
A new treatment for Clostridium difficile (C.diff) infections reduces recurrent infections by nearly 40%, a large study has found.

Ancient remedy becomes novel approach to treating Clostridium difficile infection

September 22, 2016
Modern medicine is taking a new look at an ancient remedy for severe diarrhea as a novel approach to treat a serious gastrointestinal infection.

Frozen vs. fresh fecal transplantation for C. diff. infection shows similar effectiveness

January 12, 2016
Among adults with Clostridium difficile infection that is recurrent or not responsive to treatment, the use of frozen compared with fresh fecal microbiota transplantation (FMT) did not result in a significantly lower rate ...

Study provides clues to improving fecal microbiota transplantation

December 20, 2016
Results from a placebo-controlled trial provide a strategy for improving fecal microbiota transplantation (FMT) for patients with recurrent Clostridium difficile infection. The study, published online this week in mBio, an ...

Antibiotics pave way for C. diff infections by killing bile acid-altering bacteria

January 6, 2016
New research from North Carolina State University and the University of Michigan finds that bile acids which are altered by bacteria normally living in the large intestine inhibit the growth of Clostridium difficile, or C. ...

Recommended for you

Study seeks to aid diagnosis, management of catatonia

December 11, 2017
Catatonia, a syndrome of motor, emotional and behavioral abnormalities frequently characterized by muscular rigidity and a trance-like mental stupor and at times manifesting with great excitement or agitation, can occur during ...

New compound stops progressive kidney disease in its tracks

December 7, 2017
Progressive kidney diseases, whether caused by obesity, hypertension, diabetes, or rare genetic mutations, often have the same outcome: The cells responsible for filtering the blood are destroyed. Reporting today in Science, ...

New Lyme disease tests could offer quicker, more accurate detection

December 7, 2017
New tests to detect early Lyme disease - which is increasing beyond the summer months -could replace existing tests that often do not clearly identify the infection before health problems occur.

Spinal tap needle type impacts the risk of complications

December 6, 2017
The type of needle used during a lumbar puncture makes a significant difference in the subsequent occurrence of headache, nerve irritation and hearing disturbance in patients, according to a study by Hamilton medical researchers.

Men with HPV are 20 times more likely to be reinfected after one year

December 5, 2017
A new analysis of genital human papillomavirus (HPV) in men shows that infection with one HPV type strongly increases the risk of reinfection with the same type. In fact, men who are infected with the type responsible for ...

New tuberculosis drugs possible with understanding of old antibiotic

December 5, 2017
Tuberculosis, and other life-threatening microbial diseases, could be more effectively tackled with future drugs, thanks to new research into an old antibiotic by the University of Warwick and The Francis Crick Institute.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.