Condition category
Signs and Symptoms
Date applied
08/02/2018
Date assigned
23/02/2018
Last edited
22/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ke Chen

ORCID ID

Contact details

No. 1617
Riyue Avenue
Qingyang District
Chengdu
610031
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Three combination probiotics for treatment of acute childhood diarrhea: an open labelled, randomized controlled trial

Acronym

Study hypothesis

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.

Ethics approval

The institutional ethics committee of Anhui Provincial Hospital, 13/12/2016

Study design

Multicenter randomized open-label parallel-group controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Acute childhood diarrhea

Intervention

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.

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

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

01/11/2016

Overall trial end date

30/09/2017

Reason abandoned (if study stopped)

Eligibility

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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

216

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

01/05/2017

Recruitment end date

25/09/2017

Locations

Countries of recruitment

China

Trial participating centre

Chengdu Women & Children’s Central Hospital
No. 1617 Riyue Avenue Qingyang District
Chengdu
610031
China

Sponsor information

Organisation

Infinitus (China) Company Ltd

Sponsor details

No.12
Jiangxi Road
Zhujiang New City
Tianhe District
Guangzhou
510091
China

Sponsor type

Industry

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

30/09/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes