Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03684538 |
| Other study ID # |
1022018 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2018 |
| Est. completion date |
June 30, 2020 |
Study information
| Verified date |
August 2022 |
| Source |
Makassed General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
