Clinical trial NCT04346576: Probiotics Prevent Health Problems in Children
Official title: The Effects of Fermented Milk Including Lactobacillus Casei Strain Shirota Regarding Gastrointestinal Symptoms, Respiratory Infection, Nutrition Improving in Vietnam Children 3-5 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal System Disease
Respiratory System
Keywords: Lactobacillus casei strain Shirota
diarrhea, constipation
respiratory system
nutrition status
children 3-5 years old
Lead sponsor: National Institute of Nutrition, Vietnam
Sponsor class: OTHER_GOV
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-04-15
Enrollment: 1036
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A controlled field trial was implemented with 1,036 children (3-5 years old) in Thanh Hoa province in Vietnam. The probiotic group (n=518) consumed 65 mL/day of fermented milk containing 108 CFU/mL of LcS for the 12-week intervention period, whereas the control group did not. The incidence of constipation, diarrhea, ARI, and anthropometry in children was determined at baseline and 4, 8, and 12-week of intervention and after the 4-week follow up period.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Randomized controlled field trial of a probiotics to assess its roles in the prevention or improvement of constipation and diarrhea, acute respiratory infection, nutrition improving in Vietnam children.

In the present proposal, the investigators plan to examine if daily intake of a probiotic beverage, which includes 6.5 billion probiotic Lactobacilli, has a beneficial role in protecting children from infectious diarrhea and constipation in Vietnam with 3 objectives:

1. To assess the impact of probiotics in the prevention or improvement of diarrhea and constipation in children
2. To assess the impact of probiotics in the prevention of disease of respiratory system (ARI)
3. To assess the impact of probiotics on nutrition and growth of the children

Detailed description: It will be a randomized controlled field trial involving 1036 children aged between 3 and 5 years in some communities in Vietnam. The 1036 children will be identified through demographic survey. Based on available National data to determine the province - Thanh Hoa province (http://viendinhduong.vn/news/vi/106/61/0/a/so-lieu-thong-ke-ve-tinh-trang-dinh-duong-tre-em-qua-cac-nam.aspx), after surveying 2.000 children at least 6 communes, it is expected to give 1036 eligible children. The study will be randomized where the treatment group will receive Probiotic drink, which includes 65 billion probiotic Lactobacillus casei strain Shirota, one bottle (65ml) daily for 12 weeks and the non-treatment arm will not receive the probiotic drink for 12 weeks. Randomization will be done in a ratio of 1:1, i.e., the study arm and control arm will include 518 children each. All the children under the study will be visited daily by a by teachers at kindergartens (when the children attend class), or by parents (when the children are at home). The surveillance persons will supervise the intake of Probiotic drink by the children, the status of diarrhea and constipation, disease of respiratory in children and recording the data every day. All the children will be followed up daily for 4 weeks (after stop the intervention) for identification of diarrhea and constipation cases. Functional constipation defined by ROME III was evaluated every 4 weeks. It was diagnosed by doctors with reference to the logbook records. The stool consistency was recorded in a daily logbook based on the Bristol Stool Form Scale. Diarrhea will be defined as three or more abnormally loose or liquid stools within last 24 h period. Details of such diarrhea cases including their duration, frequency of stool, type of stool (watery or bloody), other associated symptoms like abdominal pain etc. will be recorded. Qualified medical doctors will provide services for appropriate counseling and treatment and severe cases will be referred to the hospital. Doctors at commune stations are collaborate to provide service for appropriate counseling and treatment during the time of trial. And doctors at district hospitals and Thanh Hoa province will be collaborated to treat with severe cases when they are referred to. Measurements of height, weight and mid-arm circumference will assess nutritional status of the children at the beginning of the study, at the end of 4, 8, 12 weeks and (at the end of 16 weeks) follow up for 4 weeks. The outcome variables will be the incidence of diarrhea, constipation, disease of respiratory, nutrition status and the efficacy of the probiotics will be calculated by comparing the diarrhea, constipation incidence, disease of respiratory between the two groups at 5 different point of time (at baseline, the end of 4, 8, 12 weeks and 16 weeks). Nutritional improving will be compared similarly at baseline, the end of 4, 8, 12 weeks and 16 weeks.

Eligibility criteria: Inclusion Criteria:

* Children of either sex aged 3-5 years who are attending the school
* The parents/ guardians of each participating child agreed in their child participant and signed the consent form.

Exclusion Criteria:

* Children with Alzheimer's disease
* Children using long-term antibiotics
* Children with inborn chronic disease such as congenital heart disease; congenital chronic kidney failure.
* Two children in the same home (the same parents)

Primary outcomes:
measure: Incidence of constipation disease
timeFrame: 16 weeks (12 weeks of intervention and 4-weeks follow-up)
measure: Incidence of respiratory (ARI)
timeFrame: 16 weeks (12 weeks of intervention and 4-weeks follow-up)
measure: Average duration of diarrhea
timeFrame: 16 weeks (12 weeks of intervention and 4-weeks follow-up)
measure: Incidence of diarrhea disease
timeFrame: 16 weeks (12 weeks of intervention and 4-weeks follow-up)
measure: Average duration of constipation
timeFrame: 16 weeks (12 weeks of intervention and 4-weeks follow-up)
measure: Average duration of ARI
timeFrame: 16 weeks (12 weeks of intervention and 4-weeks follow-up)
measure: The weight gain
timeFrame: 16 weeks (12 weeks of intervention and 4-weeks follow-up)
measure: The height gain
timeFrame: 16 weeks (12 weeks of intervention and 4-weeks follow-up)
measure: The changes in the Z-score
timeFrame: 16 weeks (12 weeks of intervention and 4-weeks follow-up)
Secondary outcomes:
measure: Dietary intake
timeFrame: 16 weeks (12 weeks of intervention and 4-weeks follow-up)
Other outcomes:
Locations:
city: Thanh Hóa
country: Vietnam
facility: Cong Chinh, Van Thang, Dinh Thanh and Yen Thai
state: Thanh Hoa
Study officials:
affiliation: National Institute of Nutrition
name: Tuyen Le
role: STUDY_DIRECTOR
References: