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Acute Diarrhea | Effects of Probiotics and/or Prebiotics on the Duration of Diarrhea and Hospitalization in Children

Acute Diarrhea research study

What is the primary objective of this study?

- Acute diarrhea continues to be a major cause of childhood morbidity and mortality in developed and developing countries. - Prevention and treatment of dehydration are the mainstays of therapy. Rehydration can be achieved with oral rehydratation solution (ORS). - Even though ORS has reduced the mortality and morbidity very significantly, it has no effect on the duration of diarrhea, stool consistency and frequency and remains underused. - ESPGHAN and ESPID published together an evidence based guideline and stated that in the management of acute gastroenteritis rehydration is the key treatment and that selected probiotics may reduce the duration and intensity of symptoms and can be used as an adjuvant to ORS. - Current evidence also indicates that probiotic effects are strain-specific. Lactobacillus GG and Saccharomyces boulardii are the best studied strains. However, more research is needed to guide the use of particular probiotic regimens and strains and as there is still no evidence of efficacy for many preparations.

Who is eligible to participate?

Inclusion Criteria: - children of both sexes aged between 3 and 60 months, with acute watery diarrhea lasting more than 12 hours but less than 72 hours, requiring hospitalization. Children with clinical signs of mild to moderate dehydration (prolonged capillary refill time, abnormal skin turgor and 3-9% percentage loss of body weight). Exclusion Criteria: - clinical features of hypovolemic shock and/or necessitating admission at the intensive care unit were excluded. Other exclusion criteria were use of antibiotics or probiotics 1 month before admission, severe malnutrition and chronic underlying disease including immunocompromised conditions

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Acute Diarrhea

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Dietary Supplement:ProbioticComparison of probiotics vs. ORS

Dietary Supplement:ORSORS ad libitum

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

ProbioticSaccharomyces boulardii 1 x 250 mg per day for 5 days, PO or Lactobacillus GG 1 x 10(9) CFU per day for 5 days or Lactobacillus reuteri 1 x 10(8) CFU per day for 5 days

ControlORS-ad libitum

Study Status

Completed

Start Date: June 2012

Completed Date: January 2015

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Duration of diarrhea

Secondary Outcome: Percentage of children with diarrhea at the 3rd day of intervention

Study sponsors, principal investigator, and references

Principal Investigator: Ener C Dinleyici, MD

Lead Sponsor: Eskisehir Osmangazi University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01927094

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