FECAL MICROBIOTA TRANSPLANT 1

Shirley Van
May 6
th
, 2014
NURS 612 Section 01
Dr. Fetzer and Professor Kallmerten

PICO Question
Is fecal transplantation an effective treatment for patients with recurring clostridium difficile
infections?
Background & Rationale
Clostridium difficile (C. diff) is a bacteria normally found in the gastrointestinal tract. C.
diff is normally harmless when it is in small amounts, but when there is a large amount of the
bacteria in the gut it could cause diarrhea or other life threatening inflammation of the colon.
There are a lot of bacteria inside the gastrointestinal tract, and all the bacteria are usually in
balance with one another. When patients get infections, they are prescribed antibiotics. The
antibiotics may kill off some of the good bacteria in the GI tract. With the good bacteria
destroyed, C. diff is able to multiply and take over. Standard treatment for C.diff is more
antibiotics, such as vancomycin or metronidazole. Other treatments for C. diff are probiotics or
fecal microbiota transplant (Mayoclinic, 2013).
With recurring C. diff infections though, antibiotics and probiotics might not work.
Antibiotics effectiveness start to decrease with the increasing amount of recurring infections.
The other bacterial flora is also decreased by the antibiotics, causing the C. diff infection to take
over. When that occurs, fecal microbiota transplant (FMT) is introduced as another option for the
patient. Fecal transplant restores the bacterial flora and that seems to treat C.diff. This treatment
can be performed through a colonoscopy, NG tube, or through an enema. Currently, the FMT is
still considered to be experimental and the FDA only allows the procedure for patients with C.
diff and other treatments did not work. The biggest concern for the FDA is the infectious risk of
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FMT (Stein, 2013). Since the FMT treatment is recently popular, there are not many protocols on
whether it is more effective to be administered through the upper or lower GI system. The
importance of this research is to find out how effective the fecal microbiota transplant is for
patients with recurring C. diff infections. With the knowledge of the effectiveness, more patients
could be healing from the infection. C.diff is related to 14,000 deaths of patients in America
every year due to the excessive diarrhea that occurs. The number of deaths could be reduced if
FMT is proven to be an effective measure on treating resistant strains of C.diff (Center for
Disease Control, 2013).
Search Methods
The information was researched through CINAHL database and Google. On CINAHL,
the key terms that were used are fecal and transplant. Earlier in the search, I used poop
instead of fecal but no results came up so the wording was changed. The question was mainly
about fecal microbiota transplant, and so that is why those key terms were used. The full text
button was checked off, and so only a page of results came up. The limits for this research were
English and full text. I did not put a time limit on this since there were so little results, but most
of the articles were within the past two years. Another database I tried to use was Medline. Only
one result came up that had a full text article. The other articles had clinical studies, but require
payment in order to access it. The search engine that was used is Google. For Google, I typed in
fecal transplant to find out the basic information about how it works and what it is for. I used
the mayoclinic to form a background. Other websites that came up were success stories of
patients that went through FMT. A lot of the information on this website was simplified for
people with no medical background and it answered a lot of general questions regarding FMT.
That website was not included in this paper though. Some of the articles from CINAHL were
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only journal reviews, so Google was used to try to find more clinical studies. I typed in clinical
studies for fecal transplant and only one completed study came up. A lot of the other articles
talk about future studies that are currently in progress or they are recruiting participants.
Critical Appraisal of the Evidence
Recurrent Clostridium difficile could occur in anyone, but it mainly occurs in elderly.
Due to other health diseases they may have, it reduces their bodys ability to fight against C. diff
and the bacterial flora in their body is altered compared to a younger, healthier person. Older
people have a greater exposure to C. diff due to living in long-term facilities and longer hospital
stays. This nosocomial infection usually occurs after a patient has been taking antibiotics for
another bacterial infection. C. diff infection could occur when the normal bacterial flora in the
gut is reduced due to antibiotics and C. diff is resistant to the antibiotic. The C. diff bacterium is
then able to multiply and reproduce since there is a reduction in the other bacterial flora. Or C.
diff could be spread through bad hand hygiene if a nurse did not wash her hands properly after
taking care of another patient that has that infection. With a fecal transplant, it introduces the
normal bacterial flora back into the gut and balance is restored.
In the article by van Nood, et al., the study is completed with an open, randomized,
controlled trial. This study compared the different treatments for recurrent C. diff to find the most
effective treatment for the infection. Fecal transplants have been reported as a successful
treatment for recurring C. diff, but there are not many experiences with this treatment. A lot of
doctors do not want to do this procedure because there was not a lot of evidence for this practice.
With this study, there can be more evidence provided that fecal transplants do work. The study
was conducted from January 2008 to April 2010. There were a total of 43 patients in the study.
17 patients were randomly assigned to get a fecal transplant, 13 patients received the
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vancomycin, and 13 patients received the vancomycin and a bowel lavage. The criteria for this
study were patients had to be at least 18 years old, life expectancy of at least three months, and
relapsed after the initial antibiotic treatment. Patients that have a compromised immune system
were excluded from the study to prevent skewed results. Patients that were receiving the
vancomycin treatment got 500 mg of vancomycin orally for 14 days. Patients that were receiving
the vancomycin with bowel lavage received the same vancomycin medication for 14 days and
had a bowel lavage on day 4 or 5 of their treatment. The patients that received the fecal
transplant treatment started out with vancomycin (500 mg PO) for 4-5 days, and then they had a
bowel lavage on the prior to performing the fecal transplant. They received the fecal transplant
through a nasoduodenal tube. Patients that still had a recurring infection after the first initial fecal
transplant treatment received a second infusion. If the standard vancomycin treatment failed,
patients were offered the fecal transplant as an alternative. Out of the 43 patients that started the
study, 2 of them had to drop out of the study due to other health issues. One of the patients that
were a part of the vancomycin only treatment discontinued all medications due to severe heart
failure and chronic obstructive pulmonary disease. The patient passed away 13 days after being
place in the clinical trial. The second patient that dropped out of the trial was due to
discrepancies with his other health issues. The second patient had a renal transplant prior to the
study, and the patients nephrologist was against the treatment of donor feces. The patient was
placed into the vancomycin only treatment and his C. diff infection came back 41 days after
stopping the vancomycin. The patient was then placed on the donor feces treatment and was
cured, but due to the circumstances, the results were not recorded as a part of the study. Out of
the 16 patients that received the fecal infusion, 13 of the patients were cured after the first
infusion. Out of the three patients, two of them were cured after receiving a second fecal infusion.
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With those results, the study concluded that it cured 15 out of the 16 patients receiving fecal
transplant, which is a 94% success rate. A lot of the patients that received the vancomycin only
treatment and the vancomycin with the bowel lavage treatment had recurring C. diff infections
and in the end required an off protocol donor feces transplant. 15 of the 18 patients that required
this off protocol feces transplant were cured of the infection. From the results of this study, it
can be concluded that fecal transplant is an effective treatment for patients with recurring C. diff
infections. One of the strength of this study is how it is a randomized trial. Although it ended
with most of the participants getting a feces transplant, it still showed how the feces transplant
cured the patients of the C. diff infection compared to only having an antibiotic treatment. One
of the weaknesses of this study is related to the amount of participants. Since this was a smaller
group of participants, the results cannot represent a large population. At the end of the study, the
authors still followed up with the patients so recurrence rate could be recorded, which is an
additional strength to the study (van Noor, et al., 2013).
In the article by Youngster, et al., an open randomized controlled trial was completed to
compare the effectiveness between administration of fecal transplant through a nasogastric tube
and colonscopy. This study was conducted from December 2012 to May 2013. There were 20
participants between the ages of 7 to 90 years old that have recurring C. diff infections. The
participants needed to have a relapse of the infection after the initial treatment of vancomycin or
2 episodes of severe C. diff infections. If the participants had delayed gastric emptying syndrome,
compromised immune system, recurrent aspirations, or were currently pregnant at that time were
excluded from the study. There were 10 patients in each group. They were randomized to get
either a fecal transplant through a colonoscopy or a nasogastric tube. 8 out of 10 patients that
received the colonscopy transplant were cured after the first infusion. 6 out of 10 patients in the
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nasogastric tube group were cured after the first infusion. The patients in the nasogastric tube
group had to get a second infusion and only 5 of the patients continued on. One of the patients
refused to continue on with the infusions. Out of 14 patients that were cured of C. diff infection,
none of them relapsed during the 8 week follow up following the initial cure. Both methods of
administration seem to be very effective in curing C. diff infections. Most of the other studies
that were concluded about FMT had fresh donors compared to this study. With this small
randomized controlled trial, the results showed that frozen feces from unrelated donors are just
as effective as fresh feces from related donors. Although this article was about administration of
the fecal transplant and whether frozen feces are still as effective as fresh, it concluded that fecal
transplant was effective in curing C. diff infections. 14 out of 20 patients were cured and did not
relapse within the 8 weeks follow up. Randomized controlled studies make a study stronger, but
due to the small amount of sample size it also makes it a weak study. There are a lot of
limitations on participants too, which makes the study stronger so it is more controlled.
(Youngster, et al., 2014)
There are not many studies that are completed for fecal microbiota transplants.
Acccording to Burke and Lamont in their article, Fecal Transplation for Recurrent Clostridium
difficile Infection in Older Adults: A Review, they stated that there is only one randomized
controlled trial. There are nine open label, but not many of those studies were able to be accessed.
The data from the 10 articles contained 115 participants. Since this article was on older adults,
the participants are from ages 60 to 101 with mainly female participants. 103 participants were
cured using fecal transplantation, making it an 89.6% success rate. The follow up period for the
cured individuals went from 2 months to 5 years. All of the studies within the article concluded
that a fecal transplant was safe and effective treatment for recurring C. diff infections. The
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remission rates for fecal transplants were higher than patients that were on just vancomycin
treatments. Since this article is based off of results of other studies, there are not many strengths
and weaknesses. One of the strengths that could be identified is it limited to only older adults.
The limitations create a different kind of result, since older adults tend to have co-morbidities
compared to younger adults. Another strength of this article is the authors have no conflict of
interest with any of the other researchers of the studies they chose, so there is no bias in this
article (Burke and Lamont, 2013).
Evidence Synthesis
The conclusion of all three articles stated that fecal transplant is an effective treatment for
recurring C. diff infections. Each article almost had 90% success rate for remission. Each study
followed up with the patients after the remission, and there was no relapse within the follow-up
period. The follow up periods went from 2 months to 5 years. Since there are not a lot of studies
on fecal transplant, there still needs to be additional research to be done on this subject. A lot of
the articles that were found mainly talked about how fecal transplant worked but there are only a
few randomized controlled trials that are published. While researching for completed clinical
studies, a lot of in-progress clinical studies were found. There is one study that is estimated to be
completed by July 2014, and it is going to be a randomized controlled trial (Kelly, 2014).
Although there are not a sufficient amount of clinical trials, the data still yields a large amount of
success rate for fecal transplant. It is concluded to be more efficient in curing recurrent C. diff
infections compared to vancomycin treatments.
Clinical & Research Recommendation
Although the procedure of fecal transplant is not part of the nursing scope of practice, it
is still related to our practice. When patients come in with C. diff, the nurses have to care for the
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patients on a personal level. Patients would have excessive diarrhea as a symptom, and they will
have a fluid and electrolyte imbalance. When the infection cannot be stopped, it could result in
death. Over 14,000 people die each year related to fluid and electrolyte imbalance due to C. diff
infections. The number of death could be reduced if this treatment could be implemented. As
nurses, we could always bring up fecal transplants as an option to the doctors for the patient.
There are evidences that prove fecal transplants are an effective treatment for recurring C. diff
infections. There needs to be additional research done on fecal transplants. There are a lot of
articles on this subject, but there are not enough clinical studies completed on this subject. On the
website that shows clinical trials, there are some that are currently in progress and is projected to
be completed in 2014. With additional research on fecal transplant, the regulations set by the
FDA on this might not be restricted to only C. diff infections and could save many more lives.

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References
Burke, K. E., & Lamont, J. T. (2013). Fecal Transplantation for Recurrent Clostridium difficile
Infection in Older Adults: A Review.Journal Of The American Geriatrics Society, 61(8),
1394-1398. doi:10.1111/jgs.12378
Center for Disease Control. (2013). Retrieved May 5, 2014, Retrieved from
http://www.cdc.gov/hai/organisms/cdiff/cdiff_infect.html
Kelly, C. (2014). Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection.
Retrieved from http://clinicaltrials.gov/ct2/show/results/NCT01703494
Mayo Clinic Staff. (2013). C. difficile infection. Retrieved May 5, 2014, Retrieved from
http://www.mayoclinic.org/diseases-conditions/c-difficile/basics/definition/con-
20029664
Stein, R. (2013). FDA backs off on regulation of fecal transplants. Retrieved May 5, 2014,
Retrieved from http://www.npr.org/blogs/health/2013/06/18/193069110/fda-backs-off-
on-regulation-of-fecal-transplants
van Nood, E., Vrieze, A., Nieuwdorp, M., Fuentes, S., Zoetendal, E. G., de Vos, W. M., . . .
Keller, J. J. (2013). Duodenal infusion of donor feces for recurrent clostridium difficile. N
Engl J Med, 368(5), 407-415. doi:10.1056/NEJMoa1205037
Youngster, I., Sauk, J., Pindar, C., Wilson, R., Kaplan, J., Smith, M., & ... Hohmann, E. (2014).
Fecal Microbiota Transplant for Relapsing Clostridium difficile Infection Using a Frozen
Inoculum From Unrelated Donors: A Randomized, Open-Label, Controlled Pilot
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Study. Clinical Infectious Diseases: An Official Publication Of The Infectious Diseases
Society Of America,