FECAL MICROBIOTA

TRANSPLANTATION
(FMT)
Kirsten Voss
ISU Dietetic Intern, Class of 2017
Clinical Mini Case Study Topic Presentation
 Outline Objectives
1. Basics of FMT Identify patients that could benefit
2. History & Regulations from FMT.
3. C. diff infections
4. FMT Process Understand the process of FMT
5. Benefits and Risks treatment.
6. FMT Research for C. diff Infection
7. Access, Availability, Advocates
Identify benefits and risks of FMT.
8. DIY FMT Understand challenges associated
9. FMT Research for Other Conditions with receiving FMT treatments.
10. FMT vs Probiotics
11. Relevance for Clinical RD Gain insight into current and future
12. Future of FMT research on FMT.
The Basics of FMT
Stool from one person transplanted into GI tract of ill person
Transplant of entire gut microbiome

Gain metabolic activities associated with gut bacteria

Re-vamp good gut bacteria disrupted by disease or medical treatment
History of FMT
First documented in 4th century China
100+ years in veterinary medicine
Used in US since 1950s with little regulation
Spring 2013: FDA declares fecal matter as Investigational New Drug (IND) and Biologic
Specific requirements to use feces for medical treatments
June 2013: FDA reverses regulation decision ONLY for FMT used to treat recurrent C. diff
Qualified physicians can use FMT without IND application
No regulations on how stool obtained or route of FMT administration
Other uses for FMT considered experimental
Application for Investigational New Drug required
Clinical research trials
Clostridium difficile Infection
Common in health care facilities
Antibiotics used to treat variety of other infections
Gut bacteria disrupted
C. diff flourishes
Toxins released, colitis occurs
Infectious diarrhea, abdominal pain, weight loss,
poor appetite, fever
 Clostridium difficile Infection
Treated with antibiotics
Vancomycin for severe
Recurrent infection
Treat with antibiotics, FMT, probiotics
Higher risk over age 65, taking other antibiotics, other
severe medical condition (IBD)
*2011: estimated 453,000 infections
15,000 deaths directly attributed to infection
83,000 with at least 1 recurrence

*Lessa, F.C., My, Y., Bamberg, W.M., Beldavs, Z.G., Dumyati, G.K., Dunn, J.R, McDonald, C. (2015). Burden of Clostridium difficile infection in the United
States. The New England Journal of Medicine, 372 (9), 825-834.
 Benefits & Risks
*92% success rate At least 1 case of new onset
317 patients across 27 case series overweight after FMT
and reports Case report only, not proven
direct association
No documented cases of infection
Role of gut bacteria in weight?
transmission
Screening and testing Recommendations against
obese stool donors
No serious side effects
documented Long term effects unknown
Yuck factor

*Gough, E., Shaikh, H., Manges, A.R. (2011). Systematic review of intestinal microbiota transplantation (fecal
bacteriotherapy) for recurrent Clostridium difficile infection. Clinical Infectious Diseases, 53 (10), 994-1002.
FMT Process
Patients
>3 recurrences of infection w/ at least 1 failed course of vancomycin
>2 severe infections requiring hospitalization
Moderate infection not responsive to antibiotics for >1 week
Severe infection not responsive to antibiotics within 2 days

Donors
Screening
Blood tests
Stool tests
FMT Process
Procedure
Lower GI
Colonoscopy, sigmoidoscopy, enema
Upper GI
Nasoduodenal tube, nasogastric tube
Oral
Capsules from Open Biome
Extremely selective of donors, only 3% accepted

Follow up in 8 weeks with physician

Can take up to 4 days to notice improvements
 FMT for C. diff
Research
FMT more effective than
placebo or vancomycin
treatments.

Frozen and thawed FMT

equally effective as fresh FMT.

NG tube and colonoscopy

delivery equally effective.

http://www.openbiome.org/fmt-evidence/
 FMT for C. diff
Research
>80% effectiveness in
systematic reviews,
meta-analyses, and
cohort studies.

High efficacy of
capsule treatment.

http://www.openbiome.org/fmt-evidence/
Access, Availability, and Advocates
Open Biome
Non-profit stool bank and research platform
Goal: eliminate cost and coordination barriers to FMT
Safe, standardized product
Improved convenience
Reduced costs by >$3000/treatment
Expanded access
Partner with 600+ hospitals in US
$485 / dose lower GI delivery
$485 / dose upper GI delivery
$635 / dose FMT Capsule G3

http://www.openbiome.org/treatment-information
Access, Availability, and Advocates
The Fecal Transplant Foundation
Awareness and support
Local providers
Dr. Victor Lawrinenko, Dr. Michael Shekelton
OSF Gastroenterology
5105 Glen Park Place
Peoria IL 61614
309-308-5900
Insurance
Stool donors insurance may NOT cover cost of testing required to donate
No fees for transplant itself
Most insurance covers cost of colonoscopy or sigmoidoscopy
Do-it-yourself FMT?
Limited access for conditions other than C. diff infection
Simple concept
Risks with making own capsules
Importance of screening and testing
Need for sterile conditions

http://thepowerofpoop.com/epatients/fecal-transplant-instructions/
 FMT Application for Other
Medical Conditions

FMT effective in inducing ulcerative colitis

remission compared to placebo.

Improved insulin sensitivity in men with

metabolic syndrome who received intestinal
microbiota from lean donors.

FMT safely used in immunosuppressed

patients with steroid-resistant acute graft-
versus-host disease of the gut.
http://www.openbiome.org/fmt-evidence/
FMT vs Probiotics
Similar concept and applicationcorrect imbalance in gut bacteria
FMT
Involves transfer of entire gut microbiome
Regulated under FDA like a drug

Probiotics
Specific types sold as supplements or occurring naturally in foods
Regulated under FDA like a food
Available commercially
Relevance for Clinical RDs
Identify patients who may benefit from FMT
Refer to OSF Gastroenterology

FMT potential to restore gut microbiome and eliminate C. diff symptoms

Prevent further weight loss, dehydration, poor appetite

Educate others about FMT

Support FMT research
The Future of FMT
Need for awareness, education, advocates
Potentially life saving treatment
More providers and increased access to
FMT
Studies on long term effects of FMT on gut
microbiome
Need for more controlled clinical research
studies on FMT
Further research into use for other
conditions, including auto-immune
diseases
References
Alang, N. & Kelly, C.R. (2015). Weight gain after fecal microbiota transplantation. Open Forum
Infectious Diseases, 2, 1. https://doi.org/10.1093/ofid/ofv004.
The Fecal Transplant Foundation. (2017). The Fecal Transplant Foundation: Awareness and Support for
Fecal Microbiota Transplant. Retrieved from http://thefecaltransplantfoundation.org.
Gough, E., Shaikh, H., Manges, A.R. (2011). Systematic review of intestinal microbiota
transplantation (fecal bacteriotherapy) for recurrent Clostridium difficile infection. Clinical Infectious
Diseases, 53 (10), 994-1002.
Johns Hopkins Medicine. Gastroenterology and Hepatology: Fecal Transplantation (Bacteriotherapy).
Retrieved from
http://www.hopkinsmedicine.org/gastroenterology_hepatology/clinical_services/advanced_endosc
opy/fecal_transplantation.html.
Lessa, F.C., My, Y., Bamberg, W.M., Beldavs, Z.G., Dumyati, G.K., Dunn, J.R, McDonald, C. (2015).
Burden of Clostridium difficile infection in the United States. The New England Journal of Medicine,
372 (9), 825-834.
Open Biome. Open Biome. Retrieved from http://www.openbiome.org/about-fmt/.