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Completed

NCT Number: NCT01927094

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

* 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.

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Key information

Conditions

Acute Diarrhea Diarrhea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

3 month–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dr. Sami Ulus Research and Training Hospital of Women's and Children's Health and Diseases, Ankara, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic

Dietary Supplement

Comparison of probiotics vs. ORS

ORS

Dietary Supplement

ORS ad libitum

Primary outcomes

  1. Duration of diarrhea

    Time frame: Day 7

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Official study 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

Acronym: PROBAGE

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 22, 2013
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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