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

NCT03684538 | Completed

• 1 other identifier: 1022018
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Diarrhea

Outcome Measures

Primary Outcomes (1)

• Diarrhea consistency

  consistency of diarrhea scored according to the "Bristol Stool Chart"

  Till the end of diarrhea, an average of five days

Secondary Outcomes (2)

• Diarrhea duration

  Till the end of diarrhea, an average of five days

• Hospital stay

  Till the end of diarrhea, an average of four days

Study Arms (3)

Group Probiotics

EXPERIMENTAL

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; Other: Standard care

Group Zinc

EXPERIMENTAL

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; Other: Standard care

Group Probiotics & Zinc

ACTIVE COMPARATOR

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; Other: Standard care

Interventions

Probiotics OTHER

Patients will receive probiotics (Saccharomyces boulardii) one dose per day (250 mg)

Group Probiotics

Zinc OTHER

Patients will receive zinc (10 mg for patients less than 6 month and 20 mg for older patients) one dose per day

Group Zinc

Probiotics & Zinc OTHER

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

Group Probiotics & Zinc

Standard care OTHER

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

Group Probiotics; Group Probiotics & Zinc; Group Zinc

Eligibility Criteria

• Age: 31 Days - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Acute diarrhea
• Patients whose parents signed informed consent
• Patients who have dehydration according to the World Health Organization (WHO) clinical scale

You may not qualify if:

• 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

Sponsors & Collaborators

• Makassed General Hospital: lead

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon

Location

Related Publications (1)

• Collinson S, Deans A, Padua-Zamora A, Gregorio GV, Li C, Dans LF, Allen SJ. Probiotics for treating acute infectious diarrhoea. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD003048. doi: 10.1002/14651858.CD003048.pub4.

  PMID: 33295643 DERIVED

MeSH Terms

Interventions

Probiotics; Zinc; Standard of Care

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Mariam AlAbdullah A Rajab

  Makassed General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatrician

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 25, 2018
• Study Start: October 1, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: August 30, 2022

Record last verified: 2022-08

Locations

LE (1)