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Efficacy Of Probiotics vs. Zinc vs. Probiotics-Zinc Combination On Acute Diarrhea In Children

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ClinicalTrials.gov Identifier: NCT03684538
Recruitment Status : Recruiting
First Posted : September 25, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Mariam Rajab, Makassed General Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Acute Diarrhea Other: Probiotics Other: Zinc Other: Probiotics & Zinc Other: Standard care Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy Of Probiotics Versus Zinc Versus Probiotics-Zinc Combination On Acute Diarrhea In Children: A Double Blind Clinical Trial
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

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.
Other: Probiotics
Patients will receive probiotics (Saccharomyces boulardii) one dose per day (250 mg)

Other: Standard care
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.
Other: Zinc
Patients will receive zinc (10 mg for patients less than 6 month and 20 mg for older patients) one dose per day

Other: Standard care
initiation of hydration and early refeeding, in addition to the use of antimicrobials in case a pathogen was identified

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.
Other: Probiotics & Zinc
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

Other: Standard care
initiation of hydration and early refeeding, in addition to the use of antimicrobials in case a pathogen was identified




Primary Outcome Measures :
  1. Diarrhea consistency [ Time Frame: Till the end of diarrhea, an average of five days ]
    consistency of diarrhea scored according to the "Bristol Stool Chart"


Secondary Outcome Measures :
  1. Diarrhea duration [ Time Frame: Till the end of diarrhea, an average of five days ]
    duration of diarrhea in days

  2. Hospital stay [ Time Frame: Till the end of diarrhea, an average of four days ]
    Length of hospital stay in days



Information from the National Library of Medicine

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Ages Eligible for Study:   31 Days to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03684538


Contacts
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Contact: Mariam AlAbdullah A Rajab 03301846 drmariam1@hotmail.com

Locations
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Lebanon
Makassed General Hospital Recruiting
Beirut, Lebanon
Contact: Mariam Rajab, MD    +9611636000 ext 6317    drmariam1@hotmail.com   
Sponsors and Collaborators
Makassed General Hospital
Investigators
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Principal Investigator: Mariam AlAbdullah A Rajab Makassed General Hospital

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Responsible Party: Mariam Rajab, Pediatrician, Makassed General Hospital
ClinicalTrials.gov Identifier: NCT03684538     History of Changes
Other Study ID Numbers: 1022018
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Zinc
Anti-Infective Agents
Anti-Bacterial Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs