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Effects of a probiotic intervention in acute canine gastroenteritis - A controlled clinical trial

Authors:
  • Norwegian University of Life Sciences (NMBU), Campus Adamstuen, Oslo, Norway

Abstract and Figures

To evaluate the effect of a probiotic product in acute self-limiting gastroenteritis in dogs. Thirty-six dogs suffering from acute diarrhoea or acute diarrhoea and vomiting were included in the study. The trial was performed as a randomised, double blind and single centre study with stratified parallel group design. The animals were allocated to equal looking probiotic or placebo treatment by block randomisation with a fixed block size of six. The probiotic cocktail consisted of thermo-stabilised Lactobacillus acidophilus and live strains of Pediococcus acidilactici, Bacillus subtilis, Bacillus licheniformis and Lactobacillus farciminis. The time from initiation of treatment to the last abnormal stools was found to be significantly shorter (P = 0.04) in the probiotic group compared to placebo group, the mean time was 1.3 days and 2.2 days, respectively. The two groups were found nearly equal with regard to time from start of treatment to the last vomiting episode. The probiotic tested may reduce the convalescence time in acute self-limiting diarrhoea in dogs.
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PAPER
34 Journal of Small Animal Practice Vol 51 January 2010 © 2010 British Small Animal Veterinary Association
OBJECTIVES: To evaluate the effect of a probiotic product in acute
self-limiting gastroenteritis in dogs.
METHODS: Thirty-six dogs suffering from acute diarrhoea or acute
diarrhoea and vomiting were included in the study. The trial was
performed as a randomised, double blind and single centre study
with stratifi ed parallel group design. The animals were allocated to
equal looking probiotic or placebo treatment by block randomisa-
tion with a fi xed block size of six. The probiotic cocktail consisted
of thermo-stabilised Lactobacillus acidophilus and live strains of
Pediococcus acidilactici, Bacillus subtilis, Bacillus licheniformis and
Lactobacillus farciminis.
RESULTS: The time from initiation of treatment to the last abnormal
stools was found to be signifi cantly shorter (P = 0·04) in the probi-
otic group compared to placebo group, the mean time was 1·3 days
and 2·2 days, respectively. The two groups were found nearly equal
with regard to time from start of treatment to the last vomiting
episode.
CLINICAL SIGNIFICANCE: The probiotic tested may reduce the convales-
cence time in acute self-limiting diarrhoea in dogs.
INTRODUCTION
Acute gastroenteritis is a common com-
plaint in fi rst-opinion small animal prac-
tice. A wide array of disease processes may
affect the gastrointestinal tract causing
vomiting and/or diarrhoea. Usually the
cause will remain unknown as the patient
often spontaneously recovers. Supportive
therapy, including dietary modifi cations
and oral rehydration is frequently used in
handling acute, uncomplicated and non-
bloody diarrhoea (Cave 2002). In such
cases empirical administration of probiotic
products is often considered as an ancillary
treatment, intending to reduce the dura-
tion of the illness.
Probiotic are live microorganisms
which, when administered in adequate
Effects of a probiotic intervention
in acute canine gastroenteritis – a
controlled clinical trial
amounts, should have a positive effect
on human or animal health (FAO/WHO
2006). Although it is known that certain
bacterial strains exert benefi cial effect
to the host, the molecular mechanisms
behind the effect of probiotics are poorly
known in all animal species including
human beings. Possible probiotic mecha-
nisms might be to antagonise pathogenic
bacteria through competition of nutrients
or binding sites, through production of
antimicrobial substances, or modulation
of mucosal immune responses, by stimu-
lating either the innate or the adaptive
immune system (FAO/WHO 2006).
Despite the fact that probiotic products
are becoming increasingly used in small
animal practice, there are few published
studies regarding their clinical effect.
Although there are some studies con-
cerning the clinical effi cacy of probiotic
lactobacilli in chronic enteropathies (Sau-
ter and others 2006, Pascher and others
2008), their effect in acute diarrhoeas has
not yet been investigated.
The aim of the current study was to
evaluate the clinical effect of a probiotic
product applied to dogs diagnosed with
acute self-limiting gastroenteritis.
MATERIALS AND METHODS
Study design
The trial was performed as a randomised,
double blind and single centre study with
stratifi ed parallel group design. The health
condition recorded by a veterinarian was
used as stratifi cation factor (Table 1).
Within each stratum, the animals were
consecutively allocated 1:1 to probiotic or
placebo treatment, by block randomisa-
tion with a fi xed block size of six patients.
Patients
A total of 36 dogs, with a mean age of
4·1 years (sd = 3·3), suffering from acute
gastrointestinal disease were included, of
which 21 were in the placebo group and
15 in the probiotic group. Diarrhoea was
H. K. HERSTAD, B. B. NESHEIM*,
T. L A BÉE-LUND, S. LARSENAND
E. SKANCKE§
Journal of Small Animal Practice (2010)
51, 34–38
DOI: 10.1111/j.1748-5827.2009.00853.x
Accepted: 8 September 2009
Petvett Ekeberg Small Animal Clinic, Ekebergveien
177, 1177 Oslo, Norway
*Sørlandets Animal Clinic, branch offi ce Farsund,
Gamle Mosvoldvei 1, 4550 Farsund, Norway
†Department of Food Safety and Infection Biol-
ogy, ‡Centre for Epidemiology and Biostatistics
and §Department of Companion Animal Clinical
Sciences, Norwegian School of Veterinary Sci-
ence, Postboks 8146 Dep, 0033 Oslo, Norway
http://www.bsava.com/
Journal of Small Animal Practice Vol 51 January 2010 © 2010 British Small Animal Veterinary Association 35
Probiotic use in canine gastroenteritis
registered in all dogs, and 22 had simul-
taneous vomiting. Of these 22 dogs 10
were in the probiotic group and 12 in the
placebo group. The dogs were examined
by different veterinarians at the small ani-
mal out-patient clinic at the Norwegian
School of Veterinary Science. Patients
with clinical symptoms of more than two
weeks duration and patients treated with a
probiotic product within one month prior
to the study were excluded. Hospitalised
patients, including those in need of sup-
portive treatments such as fl uid therapy,
were also excluded. Patients fulfi lling the
inclusions criteria were randomised to
treatment after the owners had given con-
sent for participation.
Clinical symptoms were more fre-
quently localised to the large intestine
than to the small intestine, no signifi -
cant difference was observed between the
groups. The patients in both groups were
found equal with regard to all observed
clinical symptoms and possible factors
associated with their appearance (Table 2).
Before starting treatment the mean dura-
tion of clinical signs was 3·3 days (range:
0·5 to 10·0) in the probiotic group and
2·8 days (range: 0·5 to 7·0) in the placebo
group. The difference was not signifi cant
(P-value 0·58).
Trial treatment
The probiotic used in this study, ZooLac
Propaste (Chem Vet A/S Denmark), con-
tains per millilitre: 2·85 billions live strains
of Lactobacillus farciminis (porcine origin),
Pediococcus acidilactici (unknown origin),
Bacillus subtilis (soil origin) and Bacillus
licheniformis (soil origin) and 1·35 billions
thermo-stabilised Lactobacillus acidophilus
MA 64/4E (human origin). The probiotic
and the placebo were equal looking, and
contained the same pasta-base with vege-
table oil, lecithin and a stabiliser (E551b).
The dose of probiotic and placebo was
adjusted to the animals’ weight (1 to 10
kg = 1 ml, 10 to 25 kg = 2 ml, 25 to 50 kg
= 3 ml). The medication was administered
three times daily, starting with a double
dose, until normalisation of the stools,
all in line with recommendations by the
manufacturer. Two patients in each group
were treated with trimethoprim sulfadiazin
(Tribrissen vet; Schering-Plough) without
a well-considered medical indication.
Trial procedure
The patients were recommended not to
eat within 24 to 36 hours after the initial
treatment dose. The owners were given
written instruction related to feeding and
administration of the trial medication.
Follow-up visits were arranged four and
eight days after start of treatment where
the owner informed about faecal quality,
vomiting, administration of probiotic/pla-
cebo, food intake, date and time for the
last abnormal – and fi rst normal stool.
The time for the last abnormal stool and
rst normal stool was recorded in half (ca
12 hours) and whole (24 hours) day. These
data were used for the further statistics.
According to the information achieved
during these interviews, the overall com-
pliance regarding both eating instruction
and administration of the medication was
satisfactory.
Faecal samples for bacterial and parasi-
tological examination were collected from
33 and 17 patients, respectively. The dis-
tribution between the probiotic and pla-
cebo groups was 15 and 18 samples for
bacteriological; and 8 and 9 samples for
parasitological examination, respectively.
Faecal analysis included MgSO4-fl otation
for parasites and parasite egg examination,
and routine bacteriologic culturing for
Salmonella species, Campylobacter species
and other aerobic, anaerobic and facul-
tative anaerobic bacteria. At the time of
inclusion, no faecal parasites or Salmonella
species were detected in any of the faecal
samples collected, while Campylobacter
upsaliensis was isolated from two dogs,
both belonging to the probiotic group.
No attempt was made to isolate the pro-
biotic strain from the treated dogs, neither
during nor after completing the study.
Table I. Material description. Health
condition related to treatment group.
The health condition recorded by the
veterinarian was used as the stratifi -
cation factor
Treatment Health condition Total
Placebo Not depressed 15
Depressed 6
Probiotic Not depressed 12
Depressed 3
Total Not depressed 27
Depressed 9
Table 2 Comparison of the groups regarding initially observed anamnestic fac-
tors
Factor Category Treatment groups Total
Placebo Probiotic
Number of stools None
1–2
3–4
5
0
2
7
12
0
3
3
9
0
5
10
21
Number of vomit-
ing
None
1–2
3–4
5
9
8
3
1
5
4
5
1
14
12
8
2
First symptom Vomiting
Diarrhoea
Vomit & Diarrh
Not given
5
6
1
9
2
7
1
5
7
13
2
14
Fever No
Ye s
15
2
12
0
27
2
Appetite Reduced
Normal
Increased
8
11
0
7
7
1
15
18
1
Change in diet No
Ye s
15
5
12
2
27
7
Antiparasitic
treatment
No
Ye s
7
13
2
13
9
26
Vaccination
(DHPPi)
No
Ye s
2
18
0
15
2
33
Consumption of
spoiled food
No
Ye s
11
9
11
4
22
13
H. K. Herstad and others
36 Journal of Small Animal Practice Vol 51 January 2010 © 2010 British Small Animal Veterinary Association
Statistical analysis
Assumed continuously distributed factors
and variables were expressed as mean values
with 95% confi dence interval constructed
by using the Student procedure (Altman
1991). Standard deviation (sd) is used
as an index of dispersion. Additionally,
variables of the type “time to event” were
expressed by Kaplan & Meier plot (Parmar
and Machin 1995). Because no censoring
occurred, the results are expressed by mean
values as described above and proportional
Hazard ratio with 95% confi dence inter-
val. Categorised data in are given in con-
tingency tables. Prevalence was expressed
in percent with 95% confi dence intervals
constructed by use of the Bernoulli proce-
dure (Agresti 1990). Comparison within
and between groups was performed one
tailed and differences stated as signifi cant if
the P-value was found less or equal to 5%.
Comparison between groups with regard to
“time to event” was performed by using a
Cox proportional hazards model (Parmar
and Machin 1995). Fisher’s exact test was
used for comparison of groups regarding
categorised data. McNemar test was used
for testing changes within groups (Agresti
1990).
RESULTS
The time from start of treatment to the
last abnormal stool (Fig 1A) was found
signifi cantly shorter (P = 0·045; one-
tailed) in the probiotic group compared
to the placebo group (Table 3), the mean
time was 1·3 days (95% CI: 0·5 to 2·1)
and 2·2 days (95% CI: 1·3 to 3·1), respec-
tively. When vomiting and diarrhoea
together were taken into account the time
from start of treatment to last symptom
reported was 1·4 days (95% CI: 0·5 to 2·4)
in the probiotic group and 2·2 days (95%
CI: 1·4 to 3·1) in the placebo group (Fig
1B), and the difference was not signifi cant
(P = 0·055; one-tailed). The difference
between the groups in time from start of
treatment to the fi rst normal stool, was
neither signifi cant (P = 0·14; one-tailed).
The mean time in the probiotic group was
2·9 days (95% CI: 2·1 to 3·7) compared
to 3·4 days (95% CI: 2·6 to 4·2) in the
placebo group. In both groups the num-
ber of stools was signifi cantly reduced (P
0·01; one-tailed) during the fi rst three
days of treatment but there was no signifi -
Table 3. Proportional hazard ratio with 95% confi dence interval related to “Abnormal stools after start of treatment”,
“Normal stools after start of treatment” and “Vomiting after start of treatment”
Treatment Abnormal stools after star t of treatment Normal stools after start of treatment Vomiting after start of tr eatment
Probiotic (placebo) 0,81 0,90 0,96
0,57 – 1,09 0,63 – 1,24 0,63 – 1,48
FIG 1. Number of days from star t of treatment to (A) last abnormal stool and (B) last symptom
reported. The results are given as Kaplan & Meir plots and express the probability of reported
event at the given day
Journal of Small Animal Practice Vol 51 January 2010 © 2010 British Small Animal Veterinary Association 37
Probiotic use in canine gastroenteritis
cant difference between the two groups (P
0·19; one-tailed).
The two groups were found nearly
equal regarding mean duration of vomit-
ing with 0·9 days (95% CI: 0·5 to 1·3)
and 1·2 days (95% CI: 0·2 to 2·2) in the
probiotic group and the placebo group,
respectively. The number of vomiting epi-
sodes was signifi cantly reduced (P 0·01)
in both groups during the fi rst three days
of treatment, but the difference between
the groups was not signifi cant (P 0·16;
one-tailed).
Adverse effects were not observed in
neither of the groups, and all patients
recovered within eight days.
DISCUSSION
According to the authors’ knowledge, this
is the fi rst placebo controlled study evalu-
ating the effect of a probiotic in treatment
of acute, uncomplicated gastrointestinal
disease in dogs. In the present trial, the
probiotic signifi cantly reduced the dura-
tion of diarrhoea, although clinical signs
resolved rapidly in both groups. A reduced
symptomatic period of almost 24 hours
in the patients offered the probiotic, as
observed in this study, is a positive result
of treatment, for both the patient and the
owner.
Two patients in each group were treated
with antibiotics, without a well-consid-
ered medical indication. The patients were
treated with the same type of antibiotics.
This might have infl uenced the general
effect obtained in the study, but not the
comparison between the groups. If this
antibiotic treatment infl uenced the gen-
eral effect, it would only have increased
the dispersion of the effi cacy variable and
made it more diffi cult to obtain signifi cant
differences between the groups.
Acute self-limiting gastrointestinal
disease in dogs is frequently related to
dietary problems, but infectious agents
such as parasites, virus and bacteria may
also be responsible. Osmotic changes and
increased mucosal permeability are usually
the responsible mechanism (Guilford and
others 1996). The patient’s history may
enable the cause to be established, but in
most cases a defi nitive diagnosis followed
by a specifi c treatment, cannot be made.
The dogs included in this study were a
quite diverse group of patients suffering
from diarrhoea and in some cases vomit-
ing of unknown etiologic cause, typical of
patients visiting a fi rst-opinion practice.
Bacterial and parasitic examinations were
all negative with respect to etiologic cause.
Because examinations for parasites were
lacking in18 dogs, we cannot rule out that
some of the dogs might have suffered from
undiagnosed parasitic infections. How-
ever, the negative results from the exam-
ined specimens indicate that parasites
were not a frequent cause of the diarrhoea
in this study. Two of the dogs grew Cam-
pylobacter upsaliensis, but the signifi cance
of this species in dogs is not clear. A study
among Norwegian dogs showed no clear
association between Campylobacter isola-
tion and diarrhoea (Sandberg and others
2002).
Clinical indications for using pro-
biotic preparations in dogs are not well
defi ned and have been adapted from
concepts developed for human beings.
Some studies performed in healthy dogs
have demonstrated positive infl uence of
immune functions after administration
of probiotic bacteria (Benyacoub and
others 2003, Baillon and others 2004).
The clinical effi cacy of probiotics for the
treatment of gastrointestinal disorders in
dogs has only been evaluated in two in
vivo studies, both concerning chronic
diarrhoea. The fi rst study did not show
signifi cantly clinical effects of a probi-
otic cocktail of three canine Lactobacil-
lus species administered to dogs with
food responsive diarrhoea treated with
an elimination diet (Sauter and others
2006). In the second study, dogs suffer-
ing from chronic, non-specifi c dietary
sensitivity showed improved faecal con-
sistency, faecal dry matter and defecation
frequency while treated with the probi-
otic strain Lactobacillus acidophilus DSM
13241 (Pascher and others 2008).
The effect and mechanism of probiot-
ics in acute gastroenteritis in dogs have not
been thoroughly evaluated in contrast to
human medicine where numerous in vivo
studies have been performed. Probiotics
have been shown to signifi cantly shorten
the course of illness in children with
acute diarrhoea and also in patients suf-
fering from traveller’s diarrhoea (Simaka-
chorn and others 2000, Huang and others
2002, McFarland 2007). The study by
Simakachorn and others (2000) included
a thermo-stabilised Lactobacillus acidophi-
lus, which is a major ingredient of the pro-
biotic cocktail used in this study. However,
as the molecular mechanisms behind the
effect of a probiotic are largely unknown,
the effect and function registered in one
animal species or from one bacterium can-
not automatically be extrapolated to other
host species or probiotic strains (Isolauri
and others 2004).
For benefi cial health effects, such as
competitive exclusion of pathogens or
immune regulation, an effective probiotic
has to colonise gut mucosa at least tempo-
rarily (Salminen and others 1998). It has
been assumed that the ability to adhere to
the intestinal mucosa, to some extent, is
host species specifi c, and that the probiotic
product should contain microorganisms
originating from the same host species as
it is aimed to colonise. However, probi-
otic strains of human origin intended for
human use have been shown to adhere to
canine intestinal mucosa indicating that
species-specifi city may not always be nec-
essary for adhesion (Rinkinen and others
2000, 2003). In most cases it is compli-
cated to determine the original source of a
bacterium. According to some recommen-
dations, the specifi city of the action of a
probiotic should be assessed as important,
not the source (FAO/WHO 2006). The
bacterial strains in the probiotic prod-
uct used in our trial were not of canine
origin, and their stay in the intestine has
most likely been transient. The probiotic
still might have had the ability to adhere
to the canine mucosa. Through daily sup-
ply during the treatment period, they
may have resided for suffi cient time and
in adequate numbers to execute a possible
positive effect.
In this study there was a small but
signifi cantly positive effect of probiotic
treatment in dogs suffering from acute
gastrointestinal disease. To support these
results further controlled, clinical trials,
but also studies including adhesion mech-
anisms and other specifi c properties of the
different strains used in probiotic products
recommended for dogs, need to be done.
Even though the probiotic bacteria do not
become a part of the stable resident fl ora,
H. K. Herstad and others
38 Journal of Small Animal Practice Vol 51 January 2010 © 2010 British Small Animal Veterinary Association
they still might execute a possible positive
effect in the intestine, and should be con-
sidered as a valuable supplement to con-
servative treatment of acute gastroenteritis
in dogs. Prescription of a probiotic food
supplement, reducing the convalescence
time, may satisfy the owner’s expecta-
tions for treatment and thereby hopefully
contribute to increase the compliance of
other treatment instructions, like fasting
and dietary changes. Probiotic therapy
is also a promising option to reduce the
indiscriminate use of antimicrobials often
initiated in cases of acute gastrointestinal
disease in dogs.
Acknowledgement
The probiotic and placebo products
were kindly provided by Chem Vet A/S,
Denmark.
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... Acute and chronic enteropathies are significant causes of presentation for primary veterinary care worldwide [33][34][35] with a reported prevalence of 5%-7% for acute [36][37][38][39], and 10%-17% for chronic enteropathies [40][41][42]. In both acute and chronic enteropathies, there are significant alterations in the composition of gut microbiome communities (i.e., dysbiosis) [43][44][45][46][47][48][49][50][51][52][53][54][55][56]. ...
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