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

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ClinicalTrials.gov Identifier: NCT01927094
Recruitment Status : Completed
First Posted : August 22, 2013
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
Ener Cagri DINLEYICI, Eskisehir Osmangazi University

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

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



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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01927094


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

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    Key Record Dates
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