Effects of Probiotics and/or Prebiotics on the Duration of Diarrhea and Hospitalization in Children (PROBAGE)
Primary Purpose
Acute Diarrhea
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Probiotic
ORS
Sponsored by
About this trial
This is an interventional treatment trial for Acute Diarrhea focused on measuring probiotics, diarrhea
Eligibility 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
Sites / Locations
- Dr. Sami Ulus Research and Training Hospital of Women's and Children's Health and Diseases
- Sisli Etfal Training and Research Hospital,
- Umraniye Education & Research Hospital, Department of Pediatrics
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Probiotic
Control
Arm Description
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
ORS-ad libitum
Outcomes
Primary Outcome Measures
Duration of diarrhea
Duration of diarrhea, since the beginning of the intervention, evaluated with Bristol scoring scale
Secondary Outcome Measures
Percentage of children with diarrhea at the 3rd day of intervention
Percentage of children with diarrhea at the 3rd day of intervention
Duration of hospitalization
Lenght of stay of hoospitalization
Safety of probiotics
All clinical conditions (related with probiotics) should be noted.
Full Information
NCT ID
NCT01927094
First Posted
August 13, 2013
Last Updated
February 1, 2018
Sponsor
Eskisehir Osmangazi University
1. Study Identification
Unique Protocol Identification Number
NCT01927094
Brief Title
Effects of Probiotics and/or Prebiotics on the Duration of Diarrhea and Hospitalization in Children
Acronym
PROBAGE
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 Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eskisehir Osmangazi University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Diarrhea
Keywords
probiotics, diarrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1280 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotic
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control
Arm Type
Active Comparator
Arm Description
ORS-ad libitum
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
Comparison of probiotics vs. ORS
Intervention Type
Dietary Supplement
Intervention Name(s)
ORS
Intervention Description
ORS ad libitum
Primary Outcome Measure Information:
Title
Duration of diarrhea
Description
Duration of diarrhea, since the beginning of the intervention, evaluated with Bristol scoring scale
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Percentage of children with diarrhea at the 3rd day of intervention
Description
Percentage of children with diarrhea at the 3rd day of intervention
Time Frame
Day 3
Title
Duration of hospitalization
Description
Lenght of stay of hoospitalization
Time Frame
Day 5
Title
Safety of probiotics
Description
All clinical conditions (related with probiotics) should be noted.
Time Frame
5 days of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ener C Dinleyici, MD
Organizational Affiliation
Eskisehir Osmangazi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Sami Ulus Research and Training Hospital of Women's and Children's Health and Diseases
City
Ankara
Country
Turkey
Facility Name
Sisli Etfal Training and Research Hospital,
City
Istanbul,
ZIP/Postal Code
34000
Country
Turkey
Facility Name
Umraniye Education & Research Hospital, Department of Pediatrics
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Effects of Probiotics and/or Prebiotics on the Duration of Diarrhea and Hospitalization in Children
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