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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Acute Diarrhea	Dietary Supplement: Probiotic; Dietary Supplement: ORS	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1280 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	June 2012
Actual Primary Completion Date :	January 2015
Actual Study Completion Date :	January 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Probiotic; Saccharomyces 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	Dietary Supplement: ORS; ORS ad libitum
Active Comparator: Control; ORS-ad libitum	Dietary Supplement: Probiotic; Comparison of probiotics vs. ORS

Outcome Measures

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Primary Outcome Measures :

1. Duration of diarrhea [ Time Frame: Day 7 ]
   Duration of diarrhea, since the beginning of the intervention, evaluated with Bristol scoring scale

Secondary Outcome Measures :

1. Percentage of children with diarrhea at the 3rd day of intervention [ Time Frame: Day 3 ]
   Percentage of children with diarrhea at the 3rd day of intervention
2. Duration of hospitalization [ Time Frame: Day 5 ]
   Lenght of stay of hoospitalization
3. Safety of probiotics [ Time Frame: 5 days of intervention ]
   All clinical conditions (related with probiotics) should be noted.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	3 Months to 60 Months (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Turkey
Dr. Sami Ulus Research and Training Hospital of Women's and Children's Health and Diseases
Ankara, Turkey
Sisli Etfal Training and Research Hospital,
Istanbul,, Turkey, 34000
Umraniye Education & Research Hospital, Department of Pediatrics
Istanbul, Turkey

Sponsors and Collaborators

Eskisehir Osmangazi University

Investigators

Principal Investigator:	Ener C Dinleyici, MD	Eskisehir Osmangazi University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Ener Cagri DINLEYICI, Associate Professor in Pediatrics, Eskisehir Osmangazi University
ClinicalTrials.gov Identifier:	NCT01927094 History of Changes
Other Study ID Numbers:	PROBAGE
First Posted:	August 22, 2013
Last Update Posted:	February 2, 2018
Last Verified:	February 2018

Keywords provided by Ener Cagri DINLEYICI, Eskisehir Osmangazi University:

probiotics, diarrhea

Additional relevant MeSH terms:

Diarrhea; Signs and Symptoms, Digestive; Signs and Symptoms