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THE EFFECT OF PROBIOTICS IN THE MANAGEMENT OF DIARRHOEA DISEASE IN CHILDREN (6 MONTHS TO 5 YEARS) PRESENTING TO JOS UNIVERSITY TEACHING HOSPITAL
ABSTRACT
Objectives: To determine the effects of probiotics in the management of diarrhoea disease and associated symptoms.
Study design/setting: A randomized double blind controlled study involving children aged 6 months to 5 years presenting with diarrhoea to Jos University Teaching Hospital.
Methods: Subjects were randomly allocated to a control group and an intervention group. The subjects in the intervention group were given probiotics (Sacchromyces boulardii) and Oral Rehydration Salts while those in the control group were given a placebo and Oral Rehydration
Salts. Data was collected about the patients’ socio demographic characteristics and risk factors associated with diarrhoea. Data was also collected about the characteristics of the diarrhoea stools and associated symptoms like abdominal pain, fever and vomiting. The patients were examined before and after intervention for 5 days. Stool samples were also sent for microbiology, culture and sensitivity. Data collected after intervention included duration of diarrhoea, number of episodes of diarrhoea, weight, number of vomiting episodes and the presence or absence of fever.
Results: There was a significant difference in the mean duration of diarrhea between the probiotics group and the control group after intervention. The mean duration of diarrhoea was 45.86 hours in the probiotic group compared to 101.79 hours in the control group (p=0.00,CI 74.41 to -41.42).There was a significant reduction in the number of episodes of diarrhoea after 24 hours of intervention from a mean of 5.79 episodes to 1.59 episodes in the intervention group as compared to the control group which had a mean episode of 4.62 on day 0 to 3.90 after 24 hours (p=0.000 CI -3.06- -1.55). There was a reduction in the mean number of episodes of vomiting from 0.31 (day 0) to 0.17 (day 5) in the intervention group and from 0.21 (day 0) to 0.17 (day 5) in the control group but this was not statistically significant (p=0.8). There was no significant reduction in the number of subjects who had fever after intervention (p=0.78 at day 0 and 0.16 at 120 hours), abdominal pain (p=0.11 at day 0 and 0.09 at day 5) but there was a significant reduction in the number of individuals who had abdominal pain after 24 hours (p=0.04). Infectious agents were isolated in 30.9% of cases; Salmonella sp was isolated in 6.9% of cases, Shigella in 17.2% of cases and E histolytica and Giardia lambiia were each isolated in 3.4% of cases.
Conclusion: Probiotics (Sacchromyces boulardii) reduces the duration and number of episodes of diarrhoea. However there were no significant effects on the other symptoms associated with diarrhoea.
TABLE OF CONTENTS
Declaration – – – – – – II
Certification – – – – – – III Dedication – – – – – – IV
Acknowledgement – – – – – – – – – V
List of Abbreviations – – – – – – – – – VI
Table of Contents – – – – – – – – – VIII
List of Figures – – – – – – – – – XII
List of Tables – – – – – – – – – – XII
Abstract – – – – – – – – – – XIII
Chapter 1 – – – – – – – – – – 1
1.0 Introduction – – – – – – – – – 1
1.1Background – – – – – – – – – 1
1.2 Justification of the Study – – – – – – – – 3
1.3 Justification of the study to the discipline of family medicine – – – 5
1.4 Aims and Objectives- – – – – – – – – 6 Chapter two- – – – – – – – – – – 7
2.0 Literature Review- – – – – – – – – 7
2.1 Introduction- – – – – – – – – – 7
2.2 Epidemiology – – – – – – – – – 8
2.3 Aetiology – – – – – – – – – – 11
2.4 Cellular and Molecular mechanisms of common infectious
agents in causation of diarrhea- – – – – – – – 14
2.4.1 Bacterial Diarrhoea- – – – – – – – – 15
2.4.1.1Vibrio cholera- – – – – – – – – 16
2.4.1.2 Clostridium difficile- 17
2.4.1.3 Shigella species- – – 17
2.4.1.4 Escherichia coli- – – – – 18
2.4.2 Viral Diarrhoea- – – – – .21
2.4.2.1 Rotavirus- – – – – – – – – – 22
2.4.3.Parasitic Diarrhoea- – – – – – – – – 22
2.4.3.1 Giardia lamblia- – – – – – – – – 23
2.4.3.2 Entamoeba Histolytica- – – – – – – – 24
2.5 Types of Diarrhoea- – – – – – – – – 25
2.6 Signs and Symptoms of Dehydration – – – – – – 26
2.7 Management – – – – – – – – – 28
2.7.1 Fluid Therapy – – – – – – – – – 28
2.7.2. The role of drugs in the treatment of diarrhoea – – – – 31
2.7.3 Probiotics – – – – – – – – – 32
2.7.3.1 Introduction – – – – – – – – – 32
2.7.3.2 History of Probiotics – – – – – – – – 32
2.7.3.3 Pharmacology of Probiotics – – – – – – – 33
2.7.3.4 Benefits of Probiotics – – – – – – – – 35
2.7.3.5 Disadvantages of Probiotics – – – – – – – 44
2.7.3.6 Multi-probiotic – – – – – – – – 44
2.7.3.7 Available probiotics in Nigeria – – – – – – 44
Chapter 3 – – – – – – – – – – 46
3.0 Materials and Method– – – – – – – – – 46
3.1 Study area….. – – – – – – – – – 46
3.2 Study Population – – – – – – – – – 47
3.3 Inclusion Criteria – 47
3.4 Exclusion Criteria – – – 47
3.5 Study design – – – – – 47
3.6 Sample Size – – – – – 48
3.7 Ethical consideration- – – – – – – – – 49
3.8 Recruitment of subjects and randomization – – – – – 49
3.9 Instruments of Data collection- – – – – – – – 50
3.10 Data collection – – – – – – – – – 50
3.12 Data analysis – – – – – – – – – 52 Chapter 4 – – – – – – – – – – 54
4.1 Results – – – – – – – – – – 54
4.2 Baseline Characteristics – – – – – – – – 55
4.3 Risk factors associated with diarrhoea – – – – – – 56
4.4 Characteristics of diarrhoea stools and associated symptoms – – – 62
4.5 Outcomes of diarrhoea episodes and associated symptoms after intervention – 64
4.6 Duration of diarrhoea before and after intervention – – – – 67
Chapter 5 – – – – – – – – – – 68
5.1 Discussion – – – – – – – – – – 68
5.1.1 Baseline Demographic Characteristics – – – – – – 68
5.1.2 Risk Factors Associated with Diarrhoea- – – – – – 70
5.1.3 Characteristics of diarrhoea stools and associated symptoms- – – – 74
5.2 Strengths and limitations of the study – – – – – – 79
5.3 Implications of the study in family medicine – – – – – 80
5.4 Conclusions – – – – – – – – – 82
5.5 Recommendations – – – – – – – – – 82
5.5.1 Future Research- 82
5.5.2 The role of the family in managing Diarrhoea- 82
5.5.3 The role of the family physician in the prevention/treatment of diarrhea- 83
References – – – – – – – – – 85
Chapter 1
1.0 INTRODUCTION
1.1 BACKGROUND
Morbidity and mortality due to acute diarrhoea is significant even in the United States where diarrhoea is more often than not a “nuisance disease” in the normally healthy individual.1 Diarrhoea is a common cause of death in developing countries and the second most common cause of infant deaths worldwide.2
Diarrhoea in most western populations is defined as stool weight in excess of 200 grams per day.1 However, this definition is of little clinical value, since collecting and weighing stools is neither practical nor required except in a clinical research setting. A good working definition is three or more loose or watery stools per day or a definite decrease in consistency and increase in frequency based upon an individual baseline.1,2 It could either be secretory, osmotic,
exudative, motility related or inflammatory.1
Diarrhoea is a very common disease among children in developing countries, with an estimated frequency of about three episodes per child per year. In addition, it is one of the major under five killers worldwide. Studies have made available important and continued sources of information and constitute major evidence of the declining mortality trend from diarrhoea disease. Two decades ago, diarrhoea was responsible for almost five million deaths among children under five. Estimates have shown a steady decline ever since: 3.3 million deaths in the 1990s and 2.5 million deaths in the year 2000.3 In 2009, diarrhoea was estimated to have caused 1.1 million deaths in people aged 5 and over4 and 1.5 million deaths in children under the age of 5.5 However, in spite of this decline, diarrhoea is still the second leading cause of under five mortality globally.
It can be caused by infectious agents, malabsorption, inflammatory bowel disease, irritable bowel syndrome, chronic ethanol ingestion, ischaemic bowel syndrome and hormone secreting tumours.2,6 In a prospective case-control study of children aged 0—59 months in Kenya, Mali, Mozambique, The Gambia, Bangladesh, India, and Pakistan, four pathogens—rotavirus, Cryptosporidium, Shigella, and enterotoxigenic Escherichia coli producing heat-stable toxin— were substantial contributors to moderate and severe diarrhoea across all the study sites, whereas other pathogens were important only in some settings. The study reinforces the fact that rotavirus is a major cause of moderate-to-severe diarrhoea in children younger than five years.7
Diarrhoea diseases may cause severe loss of water and electrolytes such as sodium, chloride, potassium and bicarbonate. When there is inadequate replacement of fluids and electrolytes, children can become dehydrated. Although the early stages of dehydration present no signs or symptoms, as it advances, symptoms become pronounced and may progress to shock. If the child is not promptly rehydrated, death follows rapidly. Case fatality rates in under fives have been reported to be 0.2% in developing countries overall, ranging from 0.1 to 0.5% and being
highest in younger children.3
Dehydration can be prevented by giving the child more fluids than usual. Increased intake of fluids supplemented oral rehydration salts together with continued feeding has proven to be a powerful intervention for the prevention of childhood deaths from diarrhoea. Since the early 1980’s substantial efforts have been aimed at the reduction of diarrhoeal mortality. However considerable morbidity and mortality attributable to diarrhoea disease remain in less developed countries where poverty is the underlying factor.3 Oral rehydration salts and zinc tablets are the treatment of choice and have been estimated to have saved 50 million children in the past 25 years5 but these do not tend to reduce the duration of illness which is crucial in reducing the risk of persistent diarrhoea.8
Probiotics have been found to reduce the duration of the illness as well as having other potential benefits such as managing lactose intolerance, prevention of colonic cancer, lowering high blood pressure, improving immune function and preventing infections.8 It has been found to be useful against antibiotic-associated diarrhoea, travelers diarrhoea and paediatric diarrhoea.9 Roy Fuller defined probiotics as live microbial feed supplements which beneficially affects the host animal by improving its intestinal microbial balance.10 They have also been shown to reduce symptoms like vomiting, fever and abdominal pain which are sometimes caused by organisms that cause diarrhoea8 Lactic acid bacteria, bifidobacteria and saccharomyces
boulardii are the most common types of probiotics used.8
1.2 JUSTIFICATION FOR THE STUDY
Each year, an estimated 2.5 billion cases of diarrhoea occur among children under five years of age and more than half of these cases occur in Africa and South Asia where bouts of diarrhoea are more likely to result in death or other severe outcomes.2 It is the leading cause of malnutrition in children below five years of age.11 The youngest children are most vulnerable; incidence is highest in the first two years of life and declines as a child grows older.11 These shows that there is a need to look for new approaches in curbing diarrhoea amongst children particularly those below five years.
According to the WHO, diarrhoea kills an estimated number of 760,000 children every year globally.11 Mortality from diarrhoea has declined over the past two decades from an estimated 5 million to 1.5 million deaths in 2004. Despite this decline, diarrhoea remains the second most common cause of death among children under five globally following closely behind pneumonia, the leading killer of young children.6 While considerable progress has been made towards the Millennium Development Goals (MDGs) and childhood diarrheal diseases have reduced from 4.6 million to 0.8 million over the last three decades, the number of diarrhoeal deaths remains unacceptably high. These deaths remain concentrated in a relatively small number of countries and in poor and difficult-to-reach populations.12 Together, pneumonia and diarrhoea account for an estimated 40% of all childhood deaths around the world each year. This toll is greater than that caused by AIDS, malaria and measles combined.6 Africa and South Asia are home to more than 80% of childhood deaths due to diarrhoea.6 The statements above implies the need to look for other approaches in combating diarrhoea disease in children that reside in developing regions such as Africa and South Asia.
Oral rehydration salts and zinc tablets are the treatment of choice and have been estimated to have saved 50 million children in the past 25 years5 but these do not tend to reduce the duration of illness which is crucial in reducing the risk of persistent diarrhoea.8Waduha and colleagues in India noticed that ORS and zinc did not reduce the duration of the illness.13 This emphasizes that despite the ‘success’ of rehydration with oral rehydration salts (ORS) and intravenous fluids in the management of diarrhoea, the condition is still contributing to a high morbidity and mortality rate; hence the need to look for other approaches to curb the negative impact of diarrhoea disease. It has been noticed that in Nigeria, mothers treat diarrhoea with a combination of drugs including antibiotics, anti-diarrhoeal and herbal medicine.14 These drugs are prescribed mainly by mothers themselves and local shopkeepers. Knowledge on the adverse effects of the drugs are found to be minimal hence underscoring the need for appropriate primary care education among mothers.14 Although nearly all mothers know that Oral Rehydration Solution (ORS) could replace lost fluids, its inability to stop diarrhoea causes them to seek antibiotics from local markets, traditional medicines or anti-malarials to cure the illness with no proven benefits. Parents often deem ORS insufficient and judge that an additional treatment should be combined with ORS to cure diarrhoea.14 Several studies have proven probiotics to decrease the severity and shorten the duration of diarrhoea in children. It has been noticed to be useful in acute infective diarrhoea in children, antibiotic associated diarrhoea, travellers’ diarrhoea and lactose intolerance.15 Due to these proven benefits elsewhere, it would be worthwhile to see if these benefits would be observed in Nigerian children with diarrhoea disease hence the need for this study.
1.3 Justification of the study to the discipline of Family Medicine
The role of the family physician in the management of diarrhoea can be explained highlighting the attributes of the 6 star doctor. The family physician as a care giver ensures that a full range of treatment – curative, preventive or rehabilitative will be dispensed in ways that are complementary, integrated and continuous. He ensures that the treatment is of the highest quality.16 He is also a decision maker whereby he takes decisions that can be justified in terms of effectiveness and cost. From all the possible ways of treating a given health condition eg. Diarrhoea, the one that seems appropriate in the given situation must be chosen.16 The family physician is also a communicator whereby he involves the individual in protecting and restoring his or her own health since exposure to a health risk is largely determined by ones behaviour.16 He is also a good community leader because by understanding the determinants of health inherent in the physical and social environment and by appreciating the breadth of each problem will not simply be treating individuals who seek help but will also take a positive interest in community activities which will benefit large number of people.16 To carry out these functions, it will be essential for him to acquire managerial skills.16 This will enable him to initiate exchanges of information in order to make better decisions, and to work within a mltidisciplinary team in close association with other partners for health and social development. Lastly, he is a researcher. Both old and new methods of dispensing care (eg using ORS and probiotics) will have to be integrated into the totality of health and social services whether destined for the individual or for the community.16 The Family Physician as a primary care giver sees cases of diarrhoea disease and hence would be able to manage these cases effectively with probiotics.
1.4 Aims and Objectives
Aim
To assess the efficacy of probiotics in the management of diarrhoea so as to incorporate its use in the treatment guidelines and hence reduce the burden caused by diarrhoea disease in children aged 6 months to 5 years.
Objectives.
- To determine the average duration of episodes of diarrhea in children aged 6 months to
5 years presenting to JUTH.
- To determine the changes in duration and number of diarrhoea episodes after the administration of probiotics
- To identify possible aetiological agents of diarrhoea in cases with diarrhoea diseases
- To assess the changes in symptoms associated with diarrhoea after the administration of probiotics
THE EFFECT OF PROBIOTICS IN THE MANAGEMENT OF DIARRHOEA DISEASE IN CHILDREN (6 MONTHS TO 5 YEARS) PRESENTING TO JOS UNIVERSITY TEACHING HOSPITAL
