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

Acute Diarrhea Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01927094
• Other study ID #: PROBAGE
• Status: Completed
• Phase: Phase 4
• First received: August 13, 2013
• Last updated: February 1, 2018
• Start date: June 2012
• Est. completion date: January 2015

Study information

• Verified date: February 2018
• Source: Eskisehir Osmangazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1280
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 60 Months

Eligibility

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

Related Conditions & MeSH terms

• Acute Diarrhea
• Diarrhea

Intervention

Dietary Supplement:
• Probiotic
Comparison of probiotics vs. ORS
• ORS
ORS ad libitum

Locations

Country	Name	City	State
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,

Sponsors (1)

Lead Sponsor	Collaborator
Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of diarrhea	Duration of diarrhea, since the beginning of the intervention, evaluated with Bristol scoring scale	Day 7
Secondary	Percentage of children with diarrhea at the 3rd day of intervention	Percentage of children with diarrhea at the 3rd day of intervention	Day 3
Secondary	Duration of hospitalization	Lenght of stay of hoospitalization	Day 5
Secondary	Safety of probiotics	All clinical conditions (related with probiotics) should be noted.	5 days of intervention