The World Health Organization (WHO) defines diarrhoea as having three or more loose or watery faeces in a 24-hour period that take the form of a container (Mao et al.,2008; Narayanappa,2008). Acute diarrhoea occurred when the sickness started less than 14 days ago, while persistent diarrhoea occurs when the event has persisted for at least 14 days (Oandasam et al., 2010).  Normal newborns who are solely breastfed could regularly have loose, "pasty" stools. The criteria for this group are typically dependent on what the mother defines as diarrhoea. A bout of diarrhoea that is brought on by an infectious agent is referred to as infectious diarrhoea (Ozkan et al., 2007).

Almost two million people die each year from acute infectious diarrheal illness, an issue that affects the entire world. Around 2,00,000 children pass away from diarrheal diseases each year in Pakistan, making them a major contributor to childhood morbidity and mortality. Undernutrition results from recurrent diarrheal illnesses (Pant et al., 1996). Every child in Pakistan experiences, on average, 5–6 episodes of diarrhoea each year. In the last few decades, there has been a deeper understanding of the pathophysiology and straightforward management techniques for diarrhoea (Pashapour and Lou, 2006).

There are evidences of more than 15 species of viruses and other parasites which have been linked to acute form of diarrhoea many of them evidently cause death as the outcome among pediatric population. One of the most discussed organism is Cryptosporidium which causes many deaths all over the world throughout the globe including India annually (Michielutti et al., 1996).Travellers frequently experience acute diarrhoea, and enterotoxigenic E. coli is especially common in them. In reality, most bouts of acute diarrhoea that are thought to be brought on by an infectious agent are managed without determining the cause(Niv et al., 1963) . The main reasons for acute contagious diarrhoea vary depending on local circumstances including access to clean water and sanitary facilities. In contrast to acute contagious diarrhoea, chronic diarrhoea is likely caused by a number of other reasons, including infection (Pearce and Hamilton, 1974). 

The burden of diarrheal sickness on society as a whole is enormous. Diarrhoea causes 1.5 million deaths yearly, or 1% of mortality in children under the age of 5, despite advances in case treatment (Pedone et al ., 2000;Pene et al ., 1966) . Despite the fact that the bulk of these deaths takes place in underdeveloped countries, they are a common cause of hospital admission and medical consultation in Western cultures and have a significant social cost in terms of lost productivity for those who are affected and their caretakers(Rafeeyet al., 2008; Rautanen et al., 1998). 

According to one definition, probiotics are microbial cell preparations or parts of microbial cells that benefit the host's health and well-being. It's been done for centuries and is a common practice to ferment foods to improve their flavor and nutritional content. Lactic acid bacteria and Saccharomyces are well-known probiotics (Saint et al., 1991) .The probiotics, if consumed, has been found to dominate the nutrients pool with the pathogenic organism and as a result, the pathogenic organisms cannot survive in the environment without efficient nutrient. Biochemically, competitive inhibition takes place and gut environment becomes more acidic and variety of chemicals are produced which enhance the non-specific and specific immune response. This, again, helps in immunity against the enteric pathogenic organisms(Rautanen et al., 1998; Salazaret al., 2004 ) . To reduce diarrheal mortality and morbidity, a variety of interventional modalities have been utilised around the world. They include oral rehydration salts (ORS), ORS made from cereal, antibiotics, antidiarrheals, antispasmodics, and antiemetics (Satoh et al., 1984; Savas- Eradeve et al., 2009) .

Consuming probiotics also referred to as "good bacteria," has a multitude of positive effects on health. Given that most of the health effects attributed to probiotics are either directly or indirectly related to the gastrointestinal tract, using probiotic microorganisms for the prevention or treatment of gastrointestinal disorders is an obvious precaution and possibly the most common application of probiotics(Schrezenmeir et al., 2004 ; Singh,1987) 

The justification for using probiotics in infectious diarrhea is that they compete with enteric pathogens for nutrients and binding sites, make the gut contents acidic, produce a variety of chemicals, and boost both specific and non-specific immune responses in addition to acting against enteric pathogens. Probiotics have not been linked to any major side effects in healthy individuals, however, infrequent infections have been linked to compromised immune systems or indwelling catheters(Sudarmo et al.,2003; Tojo et al .,1987).

Research Design

A randomized study was conducted on Iraq children in Salah al-Din between 10 years and 14 years with cryptosporidial diarrhea for a duration of one year from March“2022 to February 2023. A total of 70 children were included in the study and divided into two groups placebo and probiotic groups with each group having 35 children.

 The groups that is considered for this study was given Lactobaccillus (in Probiotic group) and only cellulose (in Placebo group). 

"Probiotic" group: gelatin capsule with 1 × 1010 Lactobaccillus organisms and 170 mg of microcrystalline cellulose

 "Placebo" group: 170 mg cellulose.

Each patient underwent a thorough medical examination, which included pulse oximetry and chest auscultation, before having a faeces sample taken using a rectal swab. Using a modified acid-fast staining technique, stool samples were checked for Cryptosporidium. After 5 days of intervention, each patient was determined for the clinical features and the number of patients in each clinical feature was then analyzed against before and after the intervention. 

Inclusion and exclusion criteria

The study has included those patients who came to the gastroenterology (outpatient) department of our hospital with diarrhea with or without fever, those who follow the study protocol and from those from whom informed consent could be obtained for the study. 

Patients who did not follow the study protocol till the end or did not finish it, were excluded from the study. The patients with prior history of intestinal damage or chronic conditions like abdominal tuberculosis. 

Considering all the inclusion and exclusion criteria, the study finally considered 70 patients. 

Statistical Analysis

The study used SPSS software, version 25.0 for effective statistical analysis. The continuous data was expressed as mean ± standard deviation while the discrete data was expressed as frequency and percentage. 

The Fisher's exact test or Pearson's χ² test were used to comparing categorical variables. In cases where the data were not normally distributed, Student's t-tests or nonparametric Mann-Whitney U tests were used to compare continuous variables. , was used to conduct the statistical analysis.

Ethical Approval

The patients were given a thorough explanation of the study before the collection of the data.Each patient’s guardian needed to give written consent. The study process have been approved by The concerned hospital's Ethical Committee.

Table 1 shows the characteristics of the study population were divided into two groups placebo and probiotic group each with 35. Children in the age range of 9-12 months were higher in both groups. Acute diarrhea is seen high in the probiotic group (74.2%) and in the placebo group, it is 68.5%.  Vomitings are seen in 74.2% of the probiotic group and 71.4% in the placebo group. In 65.7% of children, there is no dehydration in placebo and 57.1% in probiotic groups. Severe dehydration is seen in 14.3% of the probiotic group. Cough and difficulty in breathing are seen in 77.1% and 11.2% of the probiotic group respectively. AIDS is suspected in 11.4% and 5.7% of placebo and probiotic group respectively.

Table 1: Baseline characteristics of the study population

Table 2 shows the baseline characteristics in both the groups. The mean duration of diarrhea is 4.7 and 5 in the placebo and probiotic groups respectively. Vomiting is seen equally in both groups 51.4%. Fever is seen as high in 91.4% of the probiotic group and 82.8% of the placebo group. No dehydration was seen in the probiotic group. Severe diarrhea is seen in 20% of probiotics and 11.4% of the placebo group. 37.1% of children present with diarrhea during followup in the probiotic group. 

Table 2: Clinical characteristics of the study population before the intervention

Table 3 shows the characteristics of children after 5 days of intervention. The mean duration o diarrhea has been decreased in the probiotic group 1.4. Vomiting is seen in 11.4% and 20% in the probiotic and placebo groups respectively. Fever is seen in 42.8% and 34.3% of placebo and probiotic group respectively. Severe diarrhea and that requires hospitalization is seen in 2.8% and 11.4% of probiotics respectively. All the clinical features and characteristics were improved in Probiotic group significantly (P < 0.05) as compared to the Placebo group, except “Associated fever”, which was not significant. 

Table 3: Clinical characteristics of the study population 5 days after the intervention

Children regularly receive antibiotic prescriptions. They change the microbial equilibrium in the digestive tract, frequently causing diarrhea brought on by antibiotics (AAD). Probiotics may stop AAD by restoring the gut's natural flora. The main goals were to evaluate the effectiveness and safety of probiotics (of any particular strain or dose) used to prevent AAD in children. Given the moderate NNT and the likelihood that adverse effects are quite uncommon, Lactobacillus rhamnosus or Saccharomyces boulardii at 5 to 40 billion colony-forming units per day may be appropriate among the numerous probiotics examined. Conclusions regarding the effectiveness and safety of other probiotic medicines for pediatric AAD are not yet appropriate. Although no serious side effects were noticed in children who were otherwise healthy, children who were severely immunosuppressed or disabled and who had underlying risk factors like the use of a central venous catheter or illnesses linked to bacterial/fungal translocation have experienced serious adverse events. Probiotic use ought to be avoided in pediatric populations at risk for undesirable effects until more research has been done (Goldenbery et al.,2015).

A study was done to determine the effectiveness and safety of Saccharomyces boulardii (S. boulardii) in treating acute watery diarrhea as well as how effective it was at lowering the frequency of episodes over the next two months. In the two months that followed, the S. boulardii group's frequency was much lower than that of the control group. The medication was well tolerated and accepted. During the course of treatment, there were no complaints of any negative effects. According to the study's findings, S. boulardii considerably decreases both the frequency and length of acute diarrhea. Moreover, the stool's consistency improves. The medication is tolerated nicely (Billo et al .,2006). 

Few research has looked at the impact of Saccharomyces boulardii, but certain probiotic agents, such as Lactobacillus GG, have demonstrated efficacy in clinical studies for the treatment of acute infantile diarrhea. The study assessed S. boulardii's impact on children with severe diarrhea. After the second day of treatment, the S. boulardii group's medians for average bowel frequency were considerably lower than those of the placebo group. When compared to the placebo group, the S. boulardii group's diarrheal symptoms were much shorter in length. After the second day of treatment, the S. boulardii effect on watery diarrhea became apparent. In comparison to the placebo group, the S. boulardii group's stay in the hospital was lower. According to the placebo-controlled study, S. boulardii considerably shortened both the length of acute diarrhoea and the length of hospital stay. When administered therapeutically, S. boulardii appears to be a potential agent for the improvement of the course of acute diarrhea in children (kurugol and Koturoglu,2005) .

A study was done to see whether the probiotic yeast Saccharomyces boulardii (S. boulardii) may lessen the duration of acute infectious gastroenteritis in infants under the age of two who were receiving ambulatory treatment. When used as an additive to ORS in ambulatory care, S. boulardii shortens the duration of mild to severe acute diarrhea in children under 2 years old, speeds up recovery, and lowers the risk of persistent diarrhea. Also, the data show that if S. boulardii is treated within the initial 48 hours after the onset of diarrhea, effectiveness is improved (Villarruel,2007).

In adults taking broad-spectrum antibiotics, co-treatment with Saccharomyces boulardii seems to reduce the risk of antibiotic-associated diarrhea. The question of whether S. boulardii shields children from antibiotic-related diarrhoea was investigated. According to the study, S. boulardii significantly lowers the incidence of pediatric antibiotic-associated diarrhoea (Kotowska et al., 2005).

A non-pathogenic probiotic yeast called Saccharomyces boulardii is thought to be effective against enteropathogens. The primary goal of the study is to evaluate S. boulardii's effectiveness in managing acute infectious diarrhoea in children. On days 3, 6, and 7, Saccharomyces boulardii dramatically decreased the risk of diarrhoea. Moreover, compared to the control group, the S. boulardii group had a considerably lower risk of diarrhoea persisting for more than 7 days. In the otherwise healthy infants and children with acute gastroenteritis, S. boulardii treatment has a modest therapeutic effect, mostly a shorter period of diarrhea (Szajewskaet al.,2009). 

Acute childhood diarrhea can be treated with oral bacteriotherapy, however, few strains have been demonstrated to have therapeutic promise. The research looked at how two recently discovered probiotic Lactobacillus strains affected acute infantile diarrhea. According to the study, two probiotics, L. rhamnosus 19070-2 and L. reuteri DSM 12246, reduced the duration of rotavirus excretion and improved acute diarrhoea in hospitalized children. An abbreviated hospital stay was linked to oral bacteriotherapy. Children who received treatment early in the diarrheal phase exhibited positive benefits the greatest ( Rosenfeldt et al .,2002 ).

It has been demonstrated that specific lactobacilli strains help hospitalized children recover from rotavirus enteritis. Probiotics' impact on children with moderate diarrhea who are not hospitalized has only been briefly studied. The mean amount of time that patients with the chosen Lactobacillus strains had diarrhea following treatment was cut in half. Probiotics were observed to have a more noticeable effect in patients who had diarrhea for at least 60 hours prior to starting medication (early intervention). The combination of L. rhamnosus 19070-2 and L. reuteri DSM 12246 proved successful in lowering the length of diarrhea in daycare center-aged children with moderate gastroenteritis (Rosenfeldt et al.,2002).

The study concluded that probiotics can be an effective therapy for intestinal damage after cryptosporidial infection. The study found that there is significant improvement in Probiotic group in terms of clinical features related to intestinal damage as compared to the placebo. The study has several limitations. The number of subjects are taken from one centre and so, there is not enough variety in the population characteristics. More over, this study has not considered those patients who already had a prior history of intestinal damage or Inflammatory Bowel Disease.  However, this study has brought forward important clinical findings which would contribute in the management of diarrhoea in much available option. 

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