ORIGINAL ARTICLE

Clinical Efficacy Comparison of Saccharomyces Boulardii and

Lactic Acid as Probiotics in Acute Pediatric Diarrhea
Shakila Asmat1,2, Fouzia Shaukat1, Raheela Asmat2, Hafiz Faiq Siddique Gul Bakhat2 and Tauseef M. Asmat2

ABSTRACT
Objective: To compare the efficacy of Saccharomyces boulardii and lactic acid producing probiotics in addition to usual
treatment regimen to cure diarrhea among children (6 months to 5 years of age).
Study Design: Randomized controlled trial.
Place and Duration of Study: Department of Pediatrics, Sheikh Zayed Hospital, Lahore, from February to July 2015.
Methodology: Children suffering from acute diarrhea were orally administered Saccharomyces boulardii and lactic acid
producing probiotics for 5 days. The efficacy of administered probiotics was monitored. Patients were given Saccharomyces
boulardii and lactic acid producing probiotics randomly to remove the bias.
Results: Two hundred patients randomly selected for trials; out of which, 100 were treated with Saccharomyces boulardii
while the other 100 were supplemented with lactic acid concomitantly along with conventional diarrhea treatment. Results
indicated that Saccharomyces boulardii treatment group has significantly higher efficacy rate (45%) compared to lactic
acid producing probiotics (26%).
Conclusion: This study concluded that Saccharomyces boulardii has a better efficacy compared to lactic acid and may
be adopted as a probiotic of choice.

Key Words: Acute diarrhea. Children. Saccharomyces boulardii. Lactic acid producing probiotics. Additive efficacy.

INTRODUCTION Probiotics are living microorganisms, commensal of

Diarrhea is defined as three or more passages of loose
or watery stool and frequent defecation in a 24-hour
period. Acute diarrhea has been reported as a second
leading cause of death (after pneumonia) in children of
age less than 5 years. Diarrhea is a worldwide health
issue accounting for an estimated 5000 deaths per day
and 1.9 million annual losses of lives at childhood. On
the basis of clinical and epidemiologic parameters,
episodes of diarrhea are classified into three categories:
acute diarrhea, dysentery, and persistent diarrhea. Acute
diarrhea is defined as the presence of three or more
loose, watery stools within a 24-hour period.2,3 In under-
developed countries, enteric bacteria such as Escherichia
coli, Campylobacter, Shigella, Vibrio cholerae, Salmonella,
viruses such as Rotavirus, Human caliciviruses, and
parasites like Cryptosporidium parvum, Giardia intestinalis,
Entamoeba histolytica, Cyclosporacayetanensis are major
pathogens to cause diarrhea.4-6 Diarrhea results in
higher amount of water losses that may lead to death, if
left untreated.1 Oral rehydration solutions (ORS) have
been found to decrease the incidence of mortality and
morbidity caused by diarrhea; but ORS did not have any
effect on the duration of the disease, consistency of the
stools, and gastrointestinal flora.4
1 Department of Pediatrics, Sheikh Zayed Hospital, Lahore.
2 Department of Pediatrics, Bolan Medical College, Quetta.
Correspondence: Dr. Shakila Asmat, LMO, Department of
Pediatrics, Bolan Medical College, Quetta.
E-mail: tauseefcasvab@gmail.com
Received: June 23, 2017; Accepted: January 01, 2018.
intestinal tract, and if required, can be administered orally
to change the micro-flora balance in the gut positively.1,4
Probiotics are effective in inhibiting the growth of harmful
bacteria, promote good digestion, boost immune
function, and increase resistance to infections.7,8 Most
common probiotics include strains of lactic acid bacilli
(Lactobacillus and Bifidobacterium), nonpathogenic
strains of Escherichia coli (E. coli), Clostridium
butyricum, Streptococcus salivarius and Saccharomyces
boulardii. Also under development are the strains of
bacteria that have been genetically engineered to
secrete immuno-modulators, such as interleukin-10,
trefoil factors, or defensins, or express altered surface
proteins such as lipoteichoic acid, which have the
potential to modulate the immune system.9 Lactic Acid
Bacteria (LAB) comprise a wide range of genera and
include a considerable number of species.10 These
bacteria are able to produce lactic acid as the main end-
product of the fermentation of carbohydrates. These acid
producing bacteria can also be used as probiotics.
Saccharomyces boulardii is a non-pathogenic probiotic
yeast and has the ability to tolerate gastric acidity and
antibiotics. Previously, it has been reported that
Saccharomyces boulardii and lactic acid producing
bacteria have effectiveness of 46.4% and 22.2%,
respectively.10 In Pakistan, both probiotics are used to
treat the acute diarrhea, but the scientific studies and
numerical data is still lacking about the comparative
effectiveness of these probiotics in Pakistan as well as in
international studies. Therefore, a prospective study was
designed to compare the efficacy of Saccharomyces

214 Journal of the College of Physicians and Surgeons Pakistan 2018, Vol. 28 (3): 214-217
Saccharomyces boulardii and lactic acid as probiotics in acute pediatric diarrhea

boulardii and lactic acid producing bacterial probiotics in
the current regimens, so that a better choice can be
made to treat acute diarrhea in children.
METHODOLOGY
This randomized controlled trial was carried out using
non-probability consecutive sampling method and it was
adapted to all subjects (200) included in this study; and
the patients were divided equally to Saccharomyces
boulardii (group A) and lactic acid administered groups
(group B). Children of both genders from 6 months to 5
years of age, suffering from diarrhea (less than 14 days),
were included in this study. Children with severe
dehydration, malnutrition, immunodeficient or already
treated with anti-diarrheal antibiotics or probiotics were
excluded from the study.
After prior approval from hospital ethical committee,
children from 6 months to 5 years of age were admitted
to the ward via OPD and emergency. A written informed
consent was obtained from the patients’ parents/
guardian. Baseline tests like CBC, urine routine
examination was done. The patients fulfilling the
inclusion criteria were included in the study. Patients’
comfort and temperature maintenance were kept in
consideration. Patients were given Saccharomyces
boulardii and lactic acid producing probiotics randomly
to eliminate the personal bias. Those patients receiving
Saccharomyces boulardii were named as group 'A' and
those receiving lactic acid producing probiotics were
labeled as group 'B'. The dose for probiotics was
administered orally twice a day in 20 ml of water for 5
days. Dosage for less than one year of age was 150 mg,
and 250 mg for children older than two years, divided
into two doses for each of Saccharomyces boulardii and
probiotics in addition to usual treatment to treat acute
diarrhea in children of age 6 months to 5 years.
Age distribution of the patients demonstrated that 61%
(n=61) in group-A and 62% (n=62) in group-B were
between 6m-3years of age; while 39% (n=39) in group-
A and 38% (n=38) in group-B were between 4-5 years of
age. Similarly, gender-based distribution of patients
treated with Saccharomyces boulardii (group-A) and
lactic acid (group-B) showed that 48% (n=48) in group-A
and 57% (n=57) in group-B were males; while 52% (n=52)
in group-A and 43% (n=43) in group-B were females.
Comparison and efficacy of Saccharomyces boulardii
(group A) with lactic acid probiotics (group B) to treat
diarrhea in children is shown in Table I. Results
demonstrated that 45% (n=45) in group-A and 26%
(n=26) in group-B were treated effectively. The results
demonstrated a significant effect of treatment (p=0.004)
as shown in Table I.
To evaluate the treatment efficacy in relation to age,
subjects were further divided into two age groups (6 months
to 3 years and 4-5 years of age). Results demonstrate
that Saccharomyces boulardii efficacy was significantly
higher (p=0.01 and p=0.001, respectively, for these two
age groups) compared to lactic acid treated patients.
Furthermore, Saccharomyces boulardii was more
effective when administered in 4-5 years age group of
patients, as shown in Table II. No significant effects
Table I: Comparison of saccharomyces boulardii (Group-A) and lactic
acid (Group-B) efficacy to treat the diarrhea patients.
Efficacy Group-A Group-B P-value
(n=100) (n=100)
No. of % No. of %
patients patients

lactic acid producing probiotics groups. The subjects Yes 45 45 26 26 0.004

were kept on same doses for 5 days. Efficacy of both No 55 55 74 74

probiotics was assessed as per operational definition Total 100 100 100 100

(frequency and consistency of stools/day). In addition to

probiotics, all patients were treated with intravenous Table II: Age-based stratification for efficacy of saccharomyces boulardii
antibiotics (ceftrioxne) and oral rehydration therapy as (Group-A) and lactic acid (Group-B).
per hospital protocol. Group Age group Efficacy P-value
Yes No
Statistical analysis was done using SPSS version 16. A 6 m - 3 year 31 30 0.01
Frequencies and percentages were calculated for B 18 44
gender and efficacy of administered probiotics. Chi- A 4 - 5 years 14 25 0.001
square test was applied to compare the efficacy of both B 27 11
groups. Data was stratified for age, gender, gestational,
weight, duration of diarrhea and socioeconomic status to
Table III: Stratification for efficacy with regard to duration of diarrhea.
deal with effect of modifiers. Post-stratification Chi-
Group Efficacy P-value
square test was applied. P-value of <0.05 was considered
Yes No
as significant. Duration 1-7 days
A 21 32 p=0.34
RESULTS B 15 34
A total of 200 cases (100 in each group), fulfilling the Duration 7-13 days

inclusion criteria, were enrolled to compare the efficacy A 24 23 0.001

of Saccharomyces boulardii and lactic acid producing B 11 40

Journal of the College of Physicians and Surgeons Pakistan 2018, Vol. 28 (3): 214-217 215
Shakila Asmat, Fouzia Shaukat, Raheela Asmat, Hafiz Faiq Siddique Gul Bakhat and Tauseef M. Asmat
(p=0.21) were observed when gender-based stratification
was performed.
Similarly, no significant difference was observed for 1-7
days treatment (p=0.34); however, the treatment of 7-13
days had a significant effect (p=0.001, Table III). This
segment of data suggests that Saccharomyces boulardii
efficacy is independent of duration of diarrhea and
equally effective at any stage of disease.
DISCUSSION
Diarrhea is defined as loose or watery stools with frequent
bowel movements (BMs) which may lead to dehydration
and ultimately to death, if left untreated. Diarrhea
may also contain blood or mucus, depending on severity
and etiology. Identifying mild diarrhea may be difficult
because in healthy children, the number and
consistency of BMs vary with age and diet. Besides
conventional and known methods to treat diarrhea,
pediatricians and scientists are interested to explore the
new horizons to treat the same more effectively and
efficiently.11 Therefore, this study was planned to
compare the efficacy of Saccharomyces boulardii with
routinely used lactic acid producing probiotic in children
suffering from diarrhea.
Saccharomyces boulardii is a beneficial yeast that was
first isolated from lychee and mangosteen fruit. In many
clinical trials, S. boulardii has been shown to be effective
in prevention and management of diarrhea, especially
antibiotic-associated diarrhea. S. boulardii can be
administered simultaneously to prevent antibiotic-
associated diarrhea, owing to its resistance to most
antibiotics.12
Sahar Feizizadeh and others have systematically
reviewed the effect of S. boulardii on acute childhood
diarrhea.13-15 Pooling data from trials showed that
S. boulardii significantly reduced the duration of
diarrhea, stool frequency on day two after intervention
compared with control.16 S. boulardii is safe and has
clear beneficial effects in children who have acute
diarrhea,17-20 and the present results are in agreement
with this study. In Pakistan, both probiotics are used to
treat the acute diarrhea, but evidence was lacking about
the comparative effectiveness of these probiotics in
Pakistan as well as in international studies. In this
regard, these results suggest that S. boulardii is
significantly more effective than lactic acid producing
bacteria. Previously, it has been reported that
Saccharomyces boulardii and yogurt fluid have
effectiveness of 46.4% and 22.2%, respectively,10 but
the authors concluded that the duration of diarrhea was
much shorter in the S. boulardii-treated group compared
to yogurt fluid group. Importantly, majority of patients
defecated normal stools on day 3 and our findings are in
accordance with these results. Therefore, this prospective
study compared the efficacy of Saccharomyces boulardii
216
with lactic acid producing bacterial probiotics and
recorded a better choice, which the physicians may
make to treat the acute diarrhea.
CONCLUSION
This study concludes that Saccharomyces boulardii is
more effective than lactic acid producing probiotics when
given along with usual treatment to treat acute diarrhea
in children of age 6 months to 5 years. These results
should be further confirmed with a large scale placebo
controlled clinical trials evaluating the efficacy of
Saccharomyces boulardii and other routinely used
probiotics.
Disclosure: The manuscript is the original study of the
corresponding author for FCPS disseratation.
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