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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ener Cagri DINLEYICI, Eskisehir Osmangazi University
ClinicalTrials.gov Identifier:
NCT01927094
First received: August 13, 2013
Last updated: February 12, 2015
Last verified: February 2015
History of Changes
  Purpose
  • 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 Intervention Phase
Acute Diarrhea
 Dietary Supplement: Probiotic
Dietary Supplement: ORS
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Further study details as provided by Eskisehir Osmangazi University:

Primary Outcome Measures:
  • Duration of diarrhea [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    Percentage of children with diarrhea at the 3rd day of intervention

  • Duration of hospitalization [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
    Lenght of stay of hoospitalization

  • Safety of probiotics [ Time Frame: 5 days of intervention ] [ Designated as safety issue: Yes ]
    All clinical conditions (related with probiotics) should be noted.
Enrollment: 1280
Study Start Date: June 2012
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility
Ages Eligible for Study:   3 Months to 60 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01927094

Locations
Turkey
Dr. Sami Ulus Research and Training Hospital of Women's and Children's Health and Diseases
Ankara, Turkey
Umraniye Education & Research Hospital, Department of Pediatrics
Istanbul, Turkey
Sisli Etfal Training and Research Hospital,
Istanbul,, Turkey, 34000
Sponsors and Collaborators
Eskisehir Osmangazi University
Investigators
Principal Investigator: Ener C Dinleyici, MD Eskisehir Osmangazi University
  More Information

No publications provided

Responsible Party: Ener Cagri DINLEYICI, Associate Professor in Pediatrics, Eskisehir Osmangazi University
ClinicalTrials.gov Identifier: NCT01927094     History of Changes
Other Study ID Numbers: PROBAGE
Study First Received: August 13, 2013
Last Updated: February 12, 2015
Health Authority: Turkey: Ministry of Health

Keywords provided by Eskisehir Osmangazi University:
probiotics, diarrhea

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on March 01, 2015