Plain English Summary
Background and study aims
The aim of this study is to assess the effectiveness and safety of a combination of three probiotics, Bifidobacterium lactis Bi-07, Lactobacillus rhamnosus HN001 and Lactobacillus acidophilus NCFM, added to rehydration therapy in the treatment of acute watery diarrhea in hospitalized children.
Who can participate?
Infants and children with mild to moderate acute diarrhea
What does the study involve?
Participants are randomly allocated to receive either conventional treatment for diarrhea or conventional treatment for diarrhea plus probiotics. The duration of diarrhea is measured.
What are the possible benefits and risks of participating?
The use of probiotics may shorten the duration of diarrhea and improve stool consistency. The potential risks include a minor allergy to the probiotics.
Where is the study run from?
Chengdu Women & Children’s Central Hospital (China)
When is the study starting and how long is it expected to run for?
November 2016 to September 2017
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Ke Chen
Three combination probiotics for treatment of acute childhood diarrhea: an open labelled, randomized controlled trial
To assess the efficacy and safety of three combination probiotics as an adjunct to rehydration therapy in the treatment of hospitalized children because of acute watery diarrhea.
The institutional ethics committee of Anhui Provincial Hospital, 13/12/2016
Multicenter randomized open-label parallel-group controlled clinical trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Acute childhood diarrhea
The randomized sequence was generated by a person not directly involved in execution of the study. The RAND function of Excel (Microsoft, Redmond, WA, USA) was used to generate computer randomly permutated codes. Simple randomization was used.
All included eligible diarrheal children were randomized to either:
1. Intervention group (IG): The preparation of three combination probiotics containing three unique strains of bacteria, Bifidobacterium lactis Bi-07, Lactobacillus rhamnosus HN001 and Lactobacillus acidophilus NCFM in addition to the standard management of diarrhea. The three combination probiotics was given as a single sachet containing more than 10 billion colony forming units (CFU) once a day from the beginning of the treatment for diarrhea until 7 days after the drug withdrawal
2. Control group (CG): No probiotic medication
Study children were managed according to the WHO guidelines which included oral rehydration therapy (ORT) with reduced osmolarity ORS and zinc (zinc sulphate dispersible tablets) 20 mg/day and continued feeding. Severe dehydration was managed with intravenous fluids (ringer lactate) as per WHO guidelines. For one single subject, the intervention duration is once the day from the beginning of the treatment for diarrhea until 7 days after drug withdrawal.
Primary outcome measures
Duration of diarrhea [time in hours from enrolment to the last abnormal (loose or liquid) stool], measured using an appropriate CRF every day during the intervention
Secondary outcome measures
Number of loose stools per day during the entire episode, measured using an appropriate CRF every day during the intervention
Overall trial start date
Overall trial end date
Participant inclusion criteria
Infants and children with an episode of mild to moderate acute diarrhea (>4 (semi)watery stools/day according to Bristol criteria (Bristol criteria ≥6)) lasting more than 12 h and less than 72 h, requiring hospitalization
Target number of participants
Participant exclusion criteria
1. Subjects with clinical features of hypovolemic shock and/or necessitating admission at the intensive care unit
2. Taking immunosuppressive therapy
3. Known immunodeficiency disorder
4. Pancreatic dysfunction
5. Bloody diarrhea
6. Chronic gastrointestinal disease
7. Short bowel syndrome
8. Bilious or bloody vomitus
9. Probiotics 1 month before admission
10. Severe malnutrition
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Chengdu Women & Children’s Central Hospital
No. 1617 Riyue Avenue Qingyang District
Investigator initiated and funded
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal and presentations at professional conferences.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Ke Chen.
Intention to publish date
Participant level data
Available on request
Results - basic reporting