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

Phase 4

Completed

• Conditions: Acute Diarrhea
• Interventions: Dietary Supplement: ORS; Dietary Supplement: Probiotic

• Registration Number: NCT01927094
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-06
• Study First Submitted: 2013-08-13
• Study First Submitted QC: 2013-08-19
• Study First Posted: 2013-08-22
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-01
• Last Update Posted: 2018-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1280

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	ORS	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
Control	Probiotic	ORS-ad libitum

Primary Outcome Measures

Name	Time	Method
Duration of diarrhea	Day 7	Duration of diarrhea, since the beginning of the intervention, evaluated with Bristol scoring scale

Secondary Outcome Measures

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

Trial Locations

Locations (3)

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

Umraniye Education & Research Hospital, Department of Pediatrics; 🇹🇷 Istanbul, Turkey