FAECAL MICROBIOTA

TRANSPLANTATION:
ESTABLISHMENT
OF A CLINICAL
APPLICATION
FRAMEWORK

Nicol Daniela Pinzón

 FAECAL MICROBIOTA
TRANSPLANTATION:
ESTABLISHMENT
OF A CLINICAL APPLICATION
FRAMEWORK
Authors

Simon M.D.
Jørgensena, Mette M.
Hansena, Christian Received 16 May 2017
Journal Impact: 2.14
Erikstrupb, Jens F. Accepted 18 July 2017
Dahlerupa and
Christian L. Hvasa

Publication
 Introduction (FMT)
FMT is superior to standard
New therapeutic option
Resolution rates antibiotic treatment for recurrent
ranging from 70 to 94% Clostridium difficile infections

processed allogenic stools

are transferred from a The objective of restoring the
healthy donor composition and functionality of
the intestinal microbiome.
For

Gastrointestinal (GI) tract of

a recipient
 Faecal microbiota transplant (FMT)
In addition to Inflammatory
RCDI bowel disease

Irritable bowel syndrome

FMT is also being

considered as a potential
treatment for Other extraintestinal
diseases where an altered The obesity
intestinal microbiome Liver diseases
may contribute to the Autoimmune disorders
pathogenesis
 Faecal microbiota transplant (FMT)
It has attracted the attention
of both the scientific
community and the general
public OBJECTIVES

Provide an oriented description

The use of EUTCD standards as
Establish the FMT as a safe of an integral clinical FMT
a regulatory basis when
and sustainable treatment framework derived from the
conducting FMT provides
modality. standards of the regulatory
useful precautionary measures
EUTCD directives.

This framework integrates the

current FMT protocols and describes
In Denmark, FMT was in detail how to comply with the
presented for the first time in EUTCD and what should be taken
2015 to be regulated by the into account in clinical practice
Danish Textile Law.
It provides an organizational structure
and clarifies both the tasks and the
personnel necessary to maintain an
operational FMT service.

of donor material

clinical application
laboratory processing
recruitment of donors
Methodology
 A clinical FMT framework

First phase

The selection of the donor The screening of donors should

To maintain FMT as a viable
includes the recruitment of be based on the risk analysis
option, the system must have a
possible donors, the screening of related to the FMT to avoid the
continuous supply of fecal donor
donors and the voluntary delivery transplantation of communicable
material from healthy donors.
of faecal donations. diseases or contagious traits
 Donor Inclusion criteria

Without medication (except No history of travel to

Age 20 - 65 Wellness contraceptives) In the last 3 countries with a high incidence
months of intestinal diseases

No antibiotics, antifungal or Without high-risk behavior (for

antifungal agents In the last 6 example, sexual contact with No tattoos or Piercing No recent blood transfusions)
months HIV)
 Donor exclusion criteria

Gastrointestinal surgery in
Moderate to severe obesity: Signs of malnutrition:
Depression history (except
BMI ≥28 kg / m2 BMI≤18 kg / m2
appendectomy)

Chronic diseases (for

autoimmune diseases example, Crohn's disease, Hematochezia Altered screening
ulcerative colitis)
Laboratory processing
All donations from a donation
round were carried out in
quarantine and approving all the
results of the laboratory tests.

Authorized personnel had to

ensure and document that all
detection parameters had been
met before launch. This practice reduces the cost and
impracticability of selecting the
donor and also limits the
the EUTCD requires that
laboratory tests be repeated after inconvenience for the donor.
a 6-month interval
 Sample application
The applicable fecal
suspensions were
The thawing procedure consecutively selected
can be started 45 and designated for the
minutes before clinical recipient. If the
application. recipient previously fails
FMT, another donor is
chosen.

Depending on the route

of administration, the
A transplant requires
compiled suspension
the compilation of three
was transferred to a vial
50 ml fecal suspensions,
of empty NS
which represent a total
(endoscopy) or three 60
of 40-50 g of undiluted
ml syringes
donor feces.
(administration of the
Faecal suspensions for clinical use should be
nasojejunal tube) maintained in quarantine until all the evidence
of the final donation has been approved
 Both
The most Administration
When The jejunum colonoscopy
frequent ways by enema was
administered required a and
to perform FMT performed
by colonoscopy, properly placed administration
are through using a
the suspension nasojejunal of the
colonoscopy, compression
was infused tube through nasojejunal
nasojejunal bottle loaded
into the which the tube required
tube with
terminal ileum donor's stool preparation
administration suspension or a
and right colon. was applied. prior to the
and enema rectal catheter.
procedure..
Colonoscopy may be preferable because it
allows the concomitant diagnosis of
colonic disease required for a colonoscopy

Several groups of patients can not undergo

pre-illness or comorbidity. In these
patients, the mild approach of nasojejunal
tube administration can be considered
favorable.

Fecal enema may be preferred in

outpatient care because of its ease of use,
lack of need for patient preparation and
minimal clinical requirements.
The emerging potential of
FMT requires a secure and
standardized application
system.
 Resultados

Usually see
Success rates
Colonoscopy control of
depend
Enema  Upper GI  to the right diarrhea
slightly on
80-85% 80-85% colon  90- symptoms
route of
95% within 48-96
delivery
hours
 Discussion

The regulation of FMT In our institution, we

as a drug will require Currently, the have made a total of
preparatory standardization and 122 FMT since the
procedures to produce homogeneity beginning of 2014,
a consistently identical requirement severely mainly in patients
product that is restricts the use of with RCDI. Ninety-
homogeneous in FMT three of these were
terms of its active . successful in the
compounds. treatment of CDI
An important aspect to keep in mind is the
management and information of the
unskilled donors that are rejected during
the selection process.

Delivery time and pressure for delivery are

very influential factors; therefore, offering
flexible opening hours and the use of
experienced donors can make donations
more reliable.

Consequently, RCDI can not be the ideal

model to validate FMT for other diseases
that are characterized by a more complex
pathogenesis and mechanisms of action.
 CONCLUSIONS
FMT does NOT
alter liver
transplant status,
FMT is safe and may resolve
CDI is a growing effective for CDI recurrent
problem with and may play a infections that
severe role in controlling delay
consequences IBD and IBS transplantation.

Oral antibiotics Currently all uses

are inferior to for FMT outside of
FMT for treatment CDI treatment are
of recurrent CDI considered
investigational
and must take
place in the
setting of a clinical
trial