Doctors from the hospital that treated a patient who died after a fecal microbiota transplant published a case study on Wednesday in the New England Journal of Medicine that offers more details on the case as well as another case in which a patient became severely ill from the procedure.
How to eradicate antibiotic overuse
FDA announced in June that it had become aware that patients who undergo FMT can experience severe or life-threatening bacterial infections caused by drug-resistant bacteria. FDA said two patients with weakened immune systems who received FMT developed infections stemming from extended-spectrum-beta-lactamase (ESBL) producing E. coli, which is resistant to antibiotics. FDA reported that one of those patients had died.
FDA said both FMTs involved stool from the same donor. The donor's stool had not been tested for ESBL-producing gram-negative organisms before the providers conducted the transplants, according to FDA.
FDA said the donor's stool underwent lab tests after the two patients experienced adverse reactions, and the tests confirmed the stored stool contained ESBL-producingE. coliidentical to the bacteria found in stool used in the two transplants.
As a result of the developments, FDA issued new safety guidelines for FMTs, saying it would now require FMTs to involve:
FDA did not provide many details on the two cases, which led doctors from Massachusetts General Hospital, where the patients were treated, to issue a report detailing the cases. Elizabeth Hohmann, co-author of the report and associate professor of medicine and infectious diseases at Mass General and Harvard Medical School, said, "We wanted to set the record straight."
According to the report, both patients were involved in clinical trials to see if FMTs could be used as a potential therapy for their conditions. One patient was in a trial to learn whether FMTs could help improve brain function in patients with severe liver disease. The other was participating in a trial to see if FMTs could be used to help immune function in leukemia patients who had undergone chemotherapy and stem cell transplants.
Two and a half weeks after doctors administered the final FMT dose to the liver disease patient, a form of E. coli was found in the patient's bloodstream, the report said. The patient recovered after intravenous antibiotics killed the bacteria.
The leukemia patient also developed the same form of drug-resistant E. coli. However, the patient had taken drugs to suppress his immune system as part of a bone marrow transplant and began to decline faster, the report said. Eight days after his last FMT dose, the patient was placed on a ventilator, and two days later the patient died from a severe bloodstream infection, according to the report.
Upon investigation of the liver patient's infection, doctors discovered that the stool sample used for the FMT contained the drug-resistant organism.
According to Hohmann, the stool donor was "what I call a 'screamingly healthy person.' Only about one in 40 people who think they might be healthy enough to [donate stool] actually turn out to meet all of our criteria. [The donor] had none of the 'risk factors' for carrying these organisms. They could not recall the last time they received antibiotics, had zero medical history, no international travel. Plus, they completed all of the other screening tests."
The doctors had been following FDA protocol testing stool donations for infectious bugs, but were not instructed by FDA to test or destroy older stool samples kept in storage, Hohmann said. The stool sample that sickened the two patients in the report had been stored in a freezer for several months.
"It wasn't obvious to a lot of smart people here," Hohmann said. "We didn't think to go back in time."
Hohmann said the report should serve as "a cautionary and sad tale. It points out some of the important medical issues about immune-compromised [patients] and maybe that changing the microbiome is not always a good idea."
Alexander Khoruts, a professor of medicine and medical director of the Microbiota Therapeutics Program at the University of Minnesota who was not involved in the report, said the report should "set off alarm bells for those who thought that [FMTs were] risk free." He added that Mass General "did the right thing" by sharing details and that he hopes the report will lead doctors to be more cautious.
Stuart Johnson, an associate professor of medicine at Loyola University Stritch School of Medicine, who specializes in the bacterial gut infection Clostridium difficile, said he thinks the report "points out that we don't know everything that's in someone's feces, and I think widespread adoption of this practice is problematic" (Carroll, NBC News, 10/30; Jacobs, New York Times, 10/30; Smith, Medium, 10/30).
- Stem Cell Therapy Los Angeles - Darrow Stem Cell Institute - February 14th, 2021
- Stem Cell Transplants: A Lifesaving Treatment for Cancer ... - February 14th, 2021
- Smart Stem Cells Made From Fat Have the Power to Heal - Freethink - February 14th, 2021
- Are Covid-19 vaccines safe for cancer patients? Here is what cancer experts say - CNN - February 14th, 2021
- The race to treat a rare, fatal syndrome may help others with common disorders like diabetes - Science Magazine - February 14th, 2021
- Arlo's Army needs stem cell donor as mum begs for help to save three-year-old's life - Glasgow Live - February 14th, 2021
- Arlo's Army: mum opens up on heartbreaking decision to make 3-year-old sick to save his life - Glasgow Live - February 14th, 2021
- Bone marrow transplant shows signs of curing brave little boy with one in a million condition - Shields Gazette - February 14th, 2021
- Canada's blood supply has a diversity problem and people are dying because of it - CBC.ca - February 2nd, 2021
- State-of-the-Art Treatments Garner University Foot and Ankle Institute Multiple Top Doctor Awards - Yahoo Finance - February 2nd, 2021
- Dean Tracy Johnson seeks to diversify the pipeline of future scientists and doctors - UCLA Newsroom - February 2nd, 2021
- Transforming optimism: finding new ways to treat rare cancers - Cancer Research UK - Science Blog - February 2nd, 2021
- Family of Belfast woman Eimear Gooderham (25) share memories and dealing with grief in special UTV programme - Belfast Telegraph - February 2nd, 2021
- Doctor: COVID-19 cases will continue to slowly go down, but were not out of the woods - Yahoo Money - January 23rd, 2021
- Global Precision Medicine Market With COVID 19 Impact Analysis| Leading Players In-depth Analysis Research Report Foresight to 2027 - KSU | The... - January 23rd, 2021
- Leading Urologist Doubles Down on CaverStem Regenerative Stem Cell Procedure for Treatment of Erectile Dysfunction in Men - PRNewswire - January 22nd, 2021
- Sisters who organised an Ilkley fundraising ball are to be honoured - Wharfedale Observer - January 22nd, 2021
- Medical Doctor: Roes Overlooking of the Consensus of Societal Morality and Science Reverberates to This Day - National Catholic Register - January 22nd, 2021
- DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL)... - January 22nd, 2021
- Seattle researchers find clues for treatments that could eliminate HIV in infected patients - GeekWire - January 14th, 2021
- Flow Cytometry Market is Projected to Reach a Value of US$8100 Mn by the End of 2025 - KSU | The Sentinel Newspaper - January 14th, 2021
- Doctors diagnosed a Suffolk teen with a rare condition. Now, his mom is part of the solution - 13newsnow.com WVEC - January 12th, 2021
- Cassville club assists 2 families as they recover from illness - telegraphherald.com - January 12th, 2021
- The 26 billion-dollar startups to watch that are revolutionizing healthcare in 2021 - Business Insider - January 12th, 2021
- Global Precision Medicine Market 2020 Overview By Size, Share, Trends, Growth Factors and Leading Players With Detailed Analysis of Industry Structure... - January 12th, 2021
- More than 250 articles and a book later, the Valley Doctor bids adieu - San Lorenzo Valley Press-Banner - January 12th, 2021
- Groundbreaking Treatment for Severe COVID-19 Using Stem Cells It's Like Smart Bomb Technology in the Lung - SciTechDaily - January 5th, 2021
- New combo therapy offered against refractory T-cell lymphoma - Korea Biomedical Review - January 5th, 2021
- Hair Growth Treatment Secrets Bollywood Will Never Tell You About - Times of India - January 5th, 2021
- Are metabolic hormones the next frontier in cancer treatment? - MedCity News - January 5th, 2021
- Limerick toddler to wait six months for trial cancer treatment after family raises over 400,000 - Extra.ie - January 5th, 2021
- West Lothian mum fighting for her life after back pain turned out to be terminal blood cancer - Edinburgh Live - January 5th, 2021
- MorphoSys and Incyte Announce the Acceptance of the Swissmedic Marketing Authorization Application for Tafasitamab - Yahoo Finance UK - January 5th, 2021
- A Wish Come True urges plungers to dump a bucket of ice water on themselves for this year's fundraiser - Fall River Herald News - December 26th, 2020
- Ashley Cain says over 80,000 people registered for stem cell donation in 48 hours after appeal to save baby - The Sun - December 22nd, 2020
- The 11 most mind-blowing, awe-inspiring health discoveries and innovations of 2020 - Business Insider - Business Insider - December 22nd, 2020
- 3-year-old patient successfully treated for rare fatal disease- familial Hemophagocytic lymphohistiocytosis (HLH) at Fortis Hospital Shalimar Bagh -... - December 22nd, 2020
- Startups are racing to reproduce breast milk in the lab - MIT Technology Review - December 22nd, 2020
- Hand weakness: Causes, symptoms, treatment, and seeking help - Medical News Today - December 22nd, 2020
- Gujarat Issues Health Advisory On Fungal Infection With "50% Mortality Rate" - NDTV - December 22nd, 2020
- A side-by-side comparison of the Pfizer/BioNTech and Moderna vaccines - STAT - December 22nd, 2020
- City of Hope Doctors Present Innovative Therapies to Better Treat Blood Cancers at American Society of Hematology Virtual Conference - Business Wire - December 9th, 2020
- Medical technologies that will disrupt (and improve) healthcare in the 2020s - Universe.byu.edu - December 9th, 2020
- Community Cord Blood Banking saves life of child with aplastic anaemia - The Hindu - November 20th, 2020
- Arya Lloyd: Father launches global search for blood stem cell donor to save his 12-year-old daughter - Sky News - November 20th, 2020
- Blood Cancer: Science Reveal Five Easily Missed Signs of Leukemia - Science Times - November 20th, 2020
- Karnataka:Community cord blood banking emerges as lifesaver - United News of India - November 18th, 2020
- How CAR-T Cell Therapy is Being Used in the Field of Blood Cancer Treatment - Curetoday.com - November 16th, 2020
- Election results for California Propositions 14, 18, 23, and 24 - FOX 11 Los Angeles - November 16th, 2020
- Cell Separation Beads Market to Witness Robust Expansion Throughout the Forecast Period 2018-2028 - The Daily Philadelphian - November 16th, 2020
- Fight for the rights of unborn - The Daily Telegram - November 11th, 2020
- Genetic Mechanism Identified in Neonatal Diabetes Could Offer Insights into Other Forms of the Disease - Genetic Engineering & Biotechnology News - November 11th, 2020
- Doctors Debate: Is Intensive or Low-Intensity Chemotherapy Plus BCR-ABL TKI Therapy Best for Treatment of Ph+ ALL? - Targeted Oncology - November 11th, 2020
- Record number of stem cell donors apply after Ex On The Beach star plea - expressandstar.com - November 11th, 2020
- Bisbee: A commitment to health care initiatives The Journal Record - Journal Record - November 11th, 2020
- California election results: Where state propositions stand as of Thursday at 5 p.m. - Desert Sun - November 11th, 2020
- Critically ill Indonesian woman thanks Taiwan for saving life - Taiwan News - November 7th, 2020
- City of Hope Doctors Present New Research on Bone Marrow Transplants, Immunotherapy and Other Blood Cancer Treatments - Business Wire - November 7th, 2020
- Daily Edition for Wednesday, November 4, 2020 - California Healthline - November 7th, 2020
- 'We're truly blood brothers' - Stanford coach David Shaw and his recent fight to save his brother, Eric - ESPN - November 7th, 2020
- 'We're really blood brothers' - Stanford coach David Shaw and his current battle to save lots of his brother, Eric - The Shepherd of the Hills Gazette - November 7th, 2020
- Mark Drought: Are we on the brink of another civil war? - The Advocate - November 7th, 2020
- What to eat when you have the flu, recommended by doctors - Business Insider India - October 30th, 2020
- Fine-Tuning Treatments for COVID-19 - American Council on Science and Health - October 30th, 2020
- Aborted girl fetus kidneys made Trumps CoV meds. As SARS2 is unfettered in America, this needs thought - Feminine-Perspective Magazine (FPMag) - October 30th, 2020
- What to Know in Washington: Provisional Ballots May Play Role - Bloomberg Government - October 30th, 2020
- Unless the country invests in cancer care, the statistics for breast cancer will be bleak: Dr Anthony Pais, .. - ETHealthworld.com - October 23rd, 2020
- Autologous Fat Grafting Market Scope Analysis 2019 to 2029 - The Think Curiouser - October 23rd, 2020
- How Clinique La Prairie Is Keeping Humanity Fashionably Healthy In The Age Of Covid - Forbes - October 23rd, 2020
- The Anthony Nolan and NHS Stem Cell Registry - The Hippocratic Post - October 21st, 2020
- Jeff Bridges is one of the 85,000-plus lymphoma cases expected in the U.S. this year - MarketWatch - October 21st, 2020
- YOUR HEALTH: Saving an unborn baby breaking apart in the womb - WQAD.com - October 21st, 2020
- Orgenesis completes acquisition of Koligo Therapeutics and announces additional acquisition of Icellator(R) Technology from Tissue Genesis in related... - October 21st, 2020
- SA becomes 2nd country to allow 16 and 17-year-olds to donate bone marrow - News24 - October 21st, 2020
- Stem Cell Therapy Market to Witness Steady Expansion During 2025 KYT24 - KYT24 - October 21st, 2020
- Mohammed Hussain Alqahtani shares his insights about the evolution of plastic surgery - LA Progressive - October 21st, 2020
- Manya Saaraswat Makes Top 5 Finish in 2020 Miss World America Competition, Three Other Indian Americans in Top 10 - India West - October 21st, 2020
- Banking wisdom: Teen saving stem cells in hopes of future treatment - LubbockOnline.com - October 15th, 2020
- Mohammed Hussain Alqahtani Discusses the Future of Plastic Surgery - The Jerusalem Post - October 15th, 2020
- The story of how a biotech co. came to the aid of an ill 9-year-old boy - Stockhouse - October 15th, 2020