Research articles
 

By Dr. M Amorissani Folquet , Dr. R Saizonou , Dr. T Guedehoussou , Dr. Yvan Vandenplas
Corresponding Author Dr. Yvan Vandenplas
Pediatrics, UZ Brussel, Laarbeeklaan 101 - Belgium 1090
Submitting Author Dr. Yvan Vandenplas
Other Authors Dr. M Amorissani Folquet
Pediatrie, - Cote D'ivoire

Dr. R Saizonou
Pediatrie, - Cote D'ivoire

Dr. T Guedehoussou
Pediatrie, - Togo

PAEDIATRICS

Diarrhea, Gastroenteritis, Saccharomyces boulardii

Amorissani Folquet M, Saizonou R, Guedehoussou T, Vandenplas Y. Saccharomyces boulardii in Acute Gastroenteritis in Children. WebmedCentral PAEDIATRICS 2011;2(11):WMC001627
doi: 10.9754/journal.wmc.2011.001627
No
Submitted on: 13 Nov 2011 02:08:31 PM GMT
Published on: 14 Nov 2011 03:00:25 PM GMT

Abstract


Objective: To evaluate Saccharomyces boulardii in the management of gastroenteritis in children in Togo, Benin and Côte d’Ivoire.
Methods: Prospective descriptive study, conducted by healthcare personnel in the 3 West African countries between May and December 2006. Well-nourished, (1 month -15 years old) children without chronic disease presenting with acute diarrhea (defined as more than 3 loose or liquid stools per 24-hour period, which started < 4 days before enrolment) were included. Stool frequency, consistency, and tolerance of treatment were evaluated at each visit.
Results: 66 investigators recruited 331 patients. The patients were predominantly male; 81% were less than 3 years old (mean age 25.6 months). The mean duration of the diarrhea before enrolment was 1.6 days. The average number of stools returned to normal (2.43 stools per day) from day 2. S. boulardii was well tolerated in 93% of cases. The treatment was shown to be effective in close to 98% of the children.
Conclusion: 81% of the children recruited were less than 3 years old. A daily dose of 500 mg S. boulardii was well tolerated, confirming the value of S. boulardii in diarrhea in children, in combination with oral rehydration therapy and early feeding.

Introduction


The aim of the recommended treatment options, oral rehydration therapy (ORT) and early feeding, is to treat and prevent the consequences of diarrhea, i.e. dehydration and malnutrition. However, these have no effect on the duration of diarrhea (1). In Togo, Benin and Côte d’Ivoire, acute diarrhea is the fourth-ranking cause of death in children under the age of 5 years, after neonatal causes, malaria, and acute respiratory infections (2). Many studies with probiotics in addition to ORT and rapid realimentation have been conducted to evaluate the efficacy of probiotics in childhood gastroenteritis (3). Two probiotic strains, Lactobacillus GG and Saccharomyces boulardii (S. boulardii) (4,5) have been best documented. The efficacy of S. boulardii in the management of gastroenteritis has been shown in several clinical trials in developing countries (6). However, the use of S. boulardii has not yet been evaluated in this part of Africa. The aim of this prospective study was therefore to evaluate the use of S. boulardii in acute gastroenteritis in children in Africa. Although the data presented result from an open, observational study, they are relevant because they represent the first systematically obtained data on acute diarrhea using S. boulardii in this part of the world.

Methods


This prospective study was conducted simultaneously in the 3 West African countries Togo, Benin and Côte d’Ivoire between May and December, 2006. Patient recruitment and follow-up were performed by healthcare personnel (doctors, nurses, medical assistants or midwives). The recruitment criteria were: children aged between 1 month and 15 years old, presenting with acute diarrhea, which was defined as at least 3 loose or liquid stools in a 24-hour period, which started less than 4 days before enrolment. Breastfed infants were considered to have diarrhea if the mother reported a significant increase in the number of stools per day and symptoms of dehydration were present. Since the etiology could not be explored in this setting, the origin of the diarrhea remains unknown. Only children with a normal baseline nutritional status and no severe signs of dehydration were included. Children presenting with fever above 38.5 °C, bloody and/or purulent stools suggesting an invasive pathogen, and diarrhea lasting for more than 4 days were excluded. Additional exclusion criteria were antifungal therapy during 48 hours prior to enrolment or antibiotic therapy during the 4 weeks prior to enrolment.
“Rehydration and resumption of appropriate feeding, according to the WHO protocol (7) were recommended in all children. In addition, S. boulardii at a dose of 250 mg, morning and evening, for 5 days, was administered.”
The study was approved by the local ethical committees. Parents had to give their informed consent before participating.
During S. boulardii treatment, a data sheet was completed, including demographic data (age, body weight, height, and sex), stool characteristics (number, consistency), associated symptoms and dose administered. An adequate amount of S. boulardii (500 mg/day for 5 days) was given free to the parents. The efficacy of the treatment was evaluated by the duration of the diarrhea, defined as the time from enrolment to the first stool of normal consistency, identical to the pre-diarrhea consistency (Bristol score)

Results


Sixty-six investigators participated in the study, and recruited 331 patients over a 7-month period. Table 1 shows the distribution of the involved healthcare personnel according to country and category. The demographic and clinical characteristics of the children are presented in Table 2. The patients were predominantly male, with a sex ratio of 1.32. Figure 1 shows the age distribution of the children. The mean age of the patients was 25.6 months, ranging from 1 month to 168 months. The vast majority (81%) of patients were under the age of 3 years. The mean duration of diarrhea prior to enrolment was 1.6 days (SD: 1.01). The requested data were adequately reported in 94% (n:292) of all included patients.
The mean duration of the diarrhea after enrolment was 2.46 days (SD: 1.09). In all but 5 patients, duration of diarrhea was less than 5 days. In other words, according to the definitions, there was a treatment failure (no normal stool before day 5 of S. boulardii treatment) in 5/292 patients (1.7 %). The mean daily number of stools on day 2 was 2.43 stools per day. S. boulardii was well tolerated (excellent or good tolerability) in 93% of cases. The questionnaire did not provide information on symptoms of intolerance. Information was reported on only one case: 1 child developed mild transient constipation; it did not require discontinuation of the treatment.
The recommended dose was administered in 89% of the patients. Lower doses were administered mainly in relation to the patient’s age.

Discussion


Childhood diarrhea is a public health problem in developing countries, with children under the age of 2 years being more frequently and more severely affected (8,9). Great effort has been made to improve the prognosis of this condition, such as oral rehydration therapy and encouraging exclusive breastfeeding. Although diarrhea is very frequent in these countries, healthcare professionals are rapidly contacted since the mean duration of diarrhea was less than 2 days. Previous campaigns to raise awareness about the impact of diarrhea in young children can be credited for this. As a consequence, the use of rehydration solutions is becoming more widespread in these countries. Although the presence of signs of diarrhea-related complications was an exclusion criterion for the study, it is interesting to observe that no case of dehydration or malnutrition was reported. This observation suggests the necessity to set-up a prospective controlled study to evaluate the hypothesis if early administration of S. boulardii may prevent the development of dehydration and chronic diarrhea also in African countries
S. boulardii is well tolerated in African children. The duration of diarrhea and stool frequency is in line with the results from previous studies in other developing countries (Table 3). Diarrhea persisted for more than 5 days in only 1.7 % of patients. Villaruel et al. demonstrated a mean difference of 1.37 days in duration of diarrhea in a group of 88 children from Salta (Argentina) treated with S. boulardi compared to placebo (10).  Also, the number of children with prolonged diarrhea (> 7 days) was significantly higher in the placebo groyp (52.2 % versus 20.4 %; RR 0.39 (0.20-0.74) (10). Kurugol and corworkers studied 200 Turkish children with acute diarrhea, and showed a decreased duration of diarrhea (7 + 2.5 versus    5.5 + 3.2 days; p = 0.03) and shorter hospital stay (2.8 + 1.1 versus 3.8 + 1.4 days; p < 0.001) (11). An open study by Billoo et al. in Pakistan resulted in similar conclusions (12). Interesting, this study suggested a smaller incidence of new episodes of diarrhea during a period of two months after treatment with S. boulardii during 5 days (13). Hafeez confirmed a decrease of duration of diarrhea with one day (3.6 versus 4.5 days) (14). Htwe showed a 1.5 days benefit in Myanmar children (3.08 versus 4.68 days). The mean duration of diarrhea in children treated with S. boulardi in this study was slightly shorter, 2.5 days. Probiotics can be used as “add-on treatment” to ORT and rapid re-alimentation in children and infants with acute diarrhea. S. boulardii was well tolerated, as no side effects were observed.

Conclusion(s)


This study involved a large number of patients. The patients recruited were mainly young children in whom diarrhea is a major issue. S. boulardii, at a dose of 500 mg/day during 5 days, produced results in line with those obtained in clinical studies published to date. These are the first data on the use of S. boulardii acute gastroenteritis coming from Togo, Benin and Côte d’Ivoire. The data suggest that epidemiology and natural evolution of acute diarrhea in this part of the world is similar to other developing countries.  The dose of 500 mg/day produced results in line with those obtained in the clinical studies published to date, being fast-acting and well tolerated.

Acknowledgements


M. Amorissani Folquet and Y. Vandenplashave received travel and unrestricted research grants from Biocodex.

References


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10. Villarruel G, Rubio DM, Lopez F, Cintioni J, Gurevech R, Romero G, Vandenplas Y. Saccharomyces boulardii in acute childhood diarrhoea: a randomized, placebo-controlled study. Acta Paediatr. 2007;96:538-41
11. Kurugöl Z, Koturoglu G. Effects of Saccharomyces boulardii in children with acute diarrhoea. Acta Paediatr. 2005;94:44-7
13. Billoo AG, Memon MA, Khaskheli SA, Murtaza G, Iqbal K, Saeed Shekhani M, Siddiqi AQ. Role of a probiotic (Saccharomyces boulardii) in management and prevention of diarrhoea. World J Gastroenterol. 2006;12:4557-60
14. Hafeez A, Tariq P, Ali S, Kundi ZU, Khan A, Hassan M. The efficacy of Saccharomyces boulardii in the treatment of acute watery diarrhoea in children: a multicentre  randomized controlled trial. J Coll Phys Surg Pakist 2002; 12: 432–4.
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Source(s) of Funding


No funding

Competing Interests


M. Amorissani Folquet and Y. Vandenplashave received travel and unrestricted research grants from Biocodex.

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