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

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

• 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.

Study Overview

• Status: Completed
• Conditions: Acute Diarrhea
• Intervention / Treatment: Dietary supplement: ORS; Dietary supplement: Probiotic

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 Type: Interventional
• Enrollment (Actual): 1280
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of diarrhea	Duration of diarrhea, since the beginning of the intervention, evaluated with Bristol scoring scale	Day 7

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Eskisehir Osmangazi University

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: August 13, 2013
• First Submitted That Met QC Criteria: August 19, 2013
• First Posted (Estimate): August 22, 2013

Study Record Updates

• Last Update Posted (Actual): February 5, 2018
• Last Update Submitted That Met QC Criteria: February 1, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: probiotics, diarrhea
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: PROBAGE