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Zinc Plus Saccharomyces Boulardii Versus Zinc Alone in the Treatment of Acute Diarrhea

M

Muhammad Aamir Latif

Status

Completed

Conditions

Acute Watery Diarrhea

Treatments

Drug: S. boulardii

Study type

Interventional

Funder types

Other

Identifiers

NCT07168304
Dr-Hammad-Multan

Details and patient eligibility

About

In literature combined therapy of zinc with S. boulardii in the treatment of acute diarrhea has not been addressed satisfactorily in the recent past. Therefore, this study was planned aiming to compare the mean time taken to resolve diarrhea and the mean time taken to resolve vomiting in children under 5 years of age having acute diarrhea with zinc plus S. boulardii versus zinc alone.

Full description

Zinc has been used as a recommended choice treating acute watery ailments among children. If any significant beneficial effect in the combined efficacy of zinc with S. boulardii is found, it may add on to pre-existing knowledge and may lead clinicians to delineate the treatment guidelines to provide more effective treatment to the patients in clinical practices to reduce undesirable morbidity.

Enrollment

276 patients

Sex

All

Ages

1 month to 5 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Children of either gender
  • Aged between 1 month up to 5 years
  • Presented with acute diarrhea

Exclusion criteria

  • Children with concurrent acute illnesses (meningitis, sepsis, or pneumonia)
  • Severe chronic conditions (cystic fibrosis, endocrinopathies, food allergies, or chronic gastrointestinal diseases)
  • Severe undernutrition (weight-for-age <60% of the 50th percentile of CDC 2000 standards)
  • Children who used probiotics, antibiotics, or anti-diarrheal drugs within the past 7 days
  • The presence of visible blood in stools

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

276 participants in 2 patient groups

Probiotic group
Experimental group
Description:
Standard treatment plus S. boulardii
Treatment:
Drug: S. boulardii
No probiotic group
No Intervention group
Description:
Standard treatment only

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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