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

The Effect of a Probiotic and/or Prebiotic on the Duration of Diarrhea and Length of Hospital Stay in Children With Acute Diarrhea: Prospective, Double Blind, Randomized Controlled Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01927094
Acronym
PROBAGE
Enrollment
1280
Registered
2013-08-22
Start date
2012-06-30
Completion date
2015-01-31
Last updated
2018-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Diarrhea

Keywords

probiotics, diarrhea

Brief summary

* 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.

Detailed description

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. A recent Cochrane review including 56 trials in children concluded that specific probiotics reduce the duration of diarrhea with about 24 hours and decrease the frequency of defecation on the second day. Current evidence also indicates that probiotic effects are strain-specific. Lactobacillus LGG 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. The aim of this study was to evaluate effects of different probiotics on the duration of acute infectious diarrhea.

Interventions

DIETARY_SUPPLEMENTProbiotic

Comparison of probiotics vs. ORS

DIETARY_SUPPLEMENTORS

ORS ad libitum

Sponsors

Eskisehir Osmangazi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Months to 60 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Duration of diarrheaDay 7Duration of diarrhea, since the beginning of the intervention, evaluated with Bristol scoring scale

Secondary

MeasureTime frameDescription
Percentage of children with diarrhea at the 3rd day of interventionDay 3Percentage of children with diarrhea at the 3rd day of intervention
Duration of hospitalizationDay 5Lenght of stay of hoospitalization
Safety of probiotics5 days of interventionAll clinical conditions (related with probiotics) should be noted.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026