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

NCT01927094 | Completed Phase 4

• 1 other identifier: PROBAGE
• Study Type: interventional
• Target: 1,280
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Diarrhea

Keywords

probiotics, diarrhea

Outcome Measures

Primary Outcomes (1)

• Duration of diarrhea

  Duration of diarrhea, since the beginning of the intervention, evaluated with Bristol scoring scale

  Day 7

Secondary Outcomes (3)

• Percentage of children with diarrhea at the 3rd day of intervention

  Day 3

• Duration of hospitalization

  Day 5

• Safety of probiotics

  5 days of intervention

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

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

Control

ACTIVE COMPARATOR

ORS-ad libitum

Dietary Supplement: Probiotic

Interventions

Probiotic DIETARY_SUPPLEMENT

Comparison of probiotics vs. ORS

Control

ORS DIETARY_SUPPLEMENT

ORS ad libitum

Probiotic

Eligibility Criteria

• Age: 3 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (3)

Dr. Sami Ulus Research and Training Hospital of Women's and Children's Health and Diseases

Ankara, Turkey (Türkiye)

Location

Sisli Etfal Training and Research Hospital,

Istanbul, 34000, Turkey (Türkiye)

Location

Umraniye Education & Research Hospital, Department of Pediatrics

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diarrhea

Interventions

Probiotics; ORALIT

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ener C Dinleyici, MD

  Eskisehir Osmangazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Pediatrics

Study Record Dates

• First Submitted: August 13, 2013
• First Posted: August 22, 2013
• Study Start: June 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: February 5, 2018

Record last verified: 2018-02

Locations

TU (3)