Efficacy Of Probiotics vs. Zinc vs. Probiotics-Zinc Combination On Acute Diarrhea In Children
Condition: Acute Diarrhea
MeSH terms: Diarrhea
Study type: Interventional

Summary: 
      Background: Acute diarrhea in children is still a major health burden worldwide despite all
      efforts that have been made to reduce its incidence and prevalence. Children are more prone
      for dehydration that is the most common serious complication of acute diarrhea and can be
      easily avoided. Initiation of rehydration, early refeeding and giving suitable antimicrobial
      agents when indicated are the cornerstone for management. In addition, studies have
      emphasized on the role and efficacy of probiotics and zinc supplements on acute diarrhea in
      children. Indeed, there are a lot of studies on the role of zinc and probiotic in reducing
      the severity of acute diarrhea, but not many studies have compared effect of using a
      combination zinc with probiotics to zinc alone and probiotics alone on acute diarrhea.

      Objective:To compare the effectiveness of use of probiotics only, zinc only, and combination
      of zinc with probiotics on the duration and consistency of diarrhea in children presented for
      acute gastroenteritis.

      Methods: A total of 240 patients diagnosed with acute diarrhea will be divided into three
      groups each of 80 patients. The first group will be managed by addition of probiotics to
      standard treatment. The second group will be managed by addition of zinc to the standard
      treatment. The third group will be managed by the addition to a combination of zinc and
      probiotics to standard treatment. The patients will be followed to compare the effect of the
      given medication on the duration of diarrhea.
    

Detailed description: 
      This is a prospective, randomized, double blinded, clinical trial that will be conducted on
      children presenting with acute diarrhea in Makassed General Hospital.

      Patient's level of dehydration will be assessed and a base line of frequency and consistency
      of diarrhea will be taken from parents'/ caregivers' history and observation. The consistency
      of stools will be scored according to the "Bristol Stool Chart". Also parents will be asked
      to sign an informed consent.

      A total of 240 eligible patients will be randomized by computer-generated numbers and the
      sealed envelope technique will be used to divide the patients into three groups.

      Group A will be composed of 80 patients. All of them will be given the standard of care
      (initiation of hydration and early refeeding, in addition to the use of antimicrobials in
      case a pathogen was identified). In addition to that, the patients in this group will receive
      probiotics (saccharomyces boulardii) one dose per day.

      Group B which will be composed of 80 patients. All of them will be given the standard of care
      (initiation of hydration and early refeeding, in addition to the use of antimicrobials in
      case a pathogen was identified). In addition to that, the patients in this group will receive
      zinc (10 mg for patients less than 6 month and 20 mg for older patients) one dose per day.

      Group C which will be composed of 80 patients. All of them will be given the standard of care
      (initiation of hydration and early refeeding, in addition to the use of antimicrobials in
      case a pathogen was identified). In addition to that, the patients in this group will receive
      a combination of probiotics (saccharomyces boulardii) with zinc (10 mg for patients less than
      6 month and 20 mg for older patients) one dose per day.

      Upon assigning the group (A, B or C), the patient will receive his daily dose of medication
      in a sealed opaque tiny bag prepared by the nursing staff by adding 5 ml water to the
      assigned medication which will be unknown to both parent and researcher.

      Patients will be assessed on a daily basis. The quality and quantity of diarrhea, as well as
      hydration status, Po intake and parents satisfaction will be assessed daily until the end of
      illness, the length of stay for hospitalized patient will be also assessed.
    

Intervention name(s): Probiotics; Zinc; Probiotics & Zinc; Standard care
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Patients will receive probiotics (Saccharomyces boulardii) one dose per day (250 mg); Patients will receive zinc (10 mg for patients less than 6 month and 20 mg for older patients) one dose per day; Patients will receive a combination of probiotics (Saccharomyces boulardii 250 mg) with zinc (10 mg for patients less than 6 month and 20 mg for older patients) one dose per day; initiation of hydration and early refeeding, in addition to the use of antimicrobials in case a pathogen was identified
Intervention MeSH terms: Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment