- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03684538
Efficacy Of Probiotics vs. Zinc vs. Probiotics-Zinc Combination On Acute Diarrhea In Children
The Efficacy Of Probiotics Versus Zinc Versus Probiotics-Zinc Combination On Acute Diarrhea In Children: A Double Blind Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Beirut, Lebanon
- Makassed General Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Acute diarrhea
- Patients whose parents signed informed consent
- Patients who have dehydration according to the World Health Organization (WHO) clinical scale
Exclusion Criteria:
- Severe dehydration
- Coexisting severe infection (e.g. sepsis, pneumonia, meningitis)
- Immune deficiency
- Patients whose parents refuse to provide written informed consent
- Patients who do not comply with treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group Probiotics
Patients in this group 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.
|
Patients will receive probiotics (Saccharomyces boulardii) one dose per day (250 mg)
initiation of hydration and early refeeding, in addition to the use of antimicrobials in case a pathogen was identified
|
Experimental: Group Zinc
Patients 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.
|
initiation of hydration and early refeeding, in addition to the use of antimicrobials in case a pathogen was identified
Patients will receive zinc (10 mg for patients less than 6 month and 20 mg for older patients) one dose per day
|
Active Comparator: Group Probiotics & Zinc
Patients 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.
|
initiation of hydration and early refeeding, in addition to the use of antimicrobials in case a pathogen was identified
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diarrhea consistency
Time Frame: Till the end of diarrhea, an average of five days
|
consistency of diarrhea scored according to the "Bristol Stool Chart"
|
Till the end of diarrhea, an average of five days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diarrhea duration
Time Frame: Till the end of diarrhea, an average of five days
|
duration of diarrhea in days
|
Till the end of diarrhea, an average of five days
|
Hospital stay
Time Frame: Till the end of diarrhea, an average of four days
|
Length of hospital stay in days
|
Till the end of diarrhea, an average of four days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mariam AlAbdullah A Rajab, Makassed General Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1022018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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