Probiotics Prevent Health Problems in Children

NCT04346576 | Completed DMC

• 2 other identifiers: NINVN12017R01DA013131
• Study Type: interventional
• Target: 1,036
• Locations: 1 country
• Sites: 1

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

Conditions

Gastrointestinal System Disease; Respiratory System

Keywords

Lactobacillus casei strain Shirota; diarrhea, constipation; respiratory system; nutrition status; children 3-5 years old

Outcome Measures

Primary Outcomes (9)

• Incidence of constipation disease

  In the primary analysis, the denominator in the calculation of incidence of constipation disease (/100 children/ week) will consist of the number of eligible children living in the study area at the time of the trial who were in between 3-5 year of age. Individuals will be included in the denominator until out-migration, death. All children will be included in the corresponding group during analyses.

  16 weeks (12 weeks of intervention and 4-weeks follow-up)

• Incidence of respiratory (ARI)

  In the primary analysis, the denominator in the calculation of incidence (/100 children/ week) will consist of the number of eligible children living in the study area at the time of the trial who were in between 3-5 year of age. Individuals will be included in the denominator until out-migration, death. All children will be included in the corresponding group during analyses.

  16 weeks (12 weeks of intervention and 4-weeks follow-up)

• Average duration of diarrhea

  Average duration of diarrhea were calculated during 12 weeks of intervention period and 4 weeks of follow-up period. If there are at least 3 diarrhea-free days between a first and a second episode of diarrhea in the same individual, the second diarrhea episode were considered as a separate (new) diarrheal episode. Evaluation of probiotic efficacy thus pertains to number of diarrheal episodes. Average duration of diarrhea were average of the day number of episodes that were determined.

  16 weeks (12 weeks of intervention and 4-weeks follow-up)

• Incidence of diarrhea disease

  n the primary analysis, the denominator in the calculation of incidence of diarrhea disease (/100 children/ week) will consist of the number of eligible children living in the study area at the time of the trial who were in between 3-5 year of age. Individuals will be included in the denominator until out-migration, death. All children will be included in the corresponding group during analyses.

  16 weeks (12 weeks of intervention and 4-weeks follow-up)

• Average duration of constipation

  Average duration of constipation were calculated during 12 weeks of intervention period and 4 weeks of follow-up period. The diagnosed constipation days between a first and a second episode of constipation in the same individual, the second constipation episode were considered as a separate (new) constipation episode. Evaluation of probiotic efficacy thus pertains to number of constipation episodes. Average duration of constipation were average of the day number of episodes that were determined.

  16 weeks (12 weeks of intervention and 4-weeks follow-up)

• Average duration of ARI

  Average duration of ARI were calculated during 12 weeks of intervention period and 4 weeks of follow-up period. The diagnosed ARI days between a first and a second episode of ARI in the same individual, the second ARI episode were considered as a separate (new) ARI episode. Evaluation of probiotic efficacy thus pertains to number of ARI episodes. Average duration of ARI were average of the day number of episodes that were determined.

  16 weeks (12 weeks of intervention and 4-weeks follow-up)

• The weight gain

  Using TANITA electronic scales with accuracy up to 0.1 kg determine the weight of children. The weight gain were determined the weight change of children after intervention compared of that before intervention. These weight gain were compared among the treatment and non-treatment group.

  16 weeks (12 weeks of intervention and 4-weeks follow-up)

• The height gain

  The height was measured by the vertical height meter with accuracy up to 1 mm. The height gain were determined the height change of children after intervention compared of that before intervention. These height gain were compared among the treatment and non-treatment group.

  16 weeks (12 weeks of intervention and 4-weeks follow-up)

• The changes in the Z-score

  Assess the nutritional status of children based on Z-Score (WHO-2006). The change in Zscore were compared among the treatment and non-treatment group.

  16 weeks (12 weeks of intervention and 4-weeks follow-up)

Secondary Outcomes (1)

• Dietary intake

  16 weeks (12 weeks of intervention and 4-weeks follow-up)

Study Arms (1)

Probiotics (LcS per 65 mL) prevent health problems in children

EXPERIMENTAL

Probiotic test product was fermented milk containing 6.5 billion of LcS per 65 mL (108 CFU/mL), manufactured by Yakult Vietnam, Co., Ltd. The nutritional composition of the test product is 0.8 g of protein, \<0.1 g of fat, 12.4 g of carbohydrates, and the total energy is 52.7 kcal per bottle. Subjects were asked to drink one bottle of the test product per day after lunch for 12 weeks on consecutive days. The test products were stored in a refrigerator (\< 10°C), protected from direct sunlight, and used before their expiration date. Adherence to the intervention protocol was confirmed as follows; teachers at kindergartens or parents at home provided the probiotic drinks (1 bottle/day x 7 days/week) after lunch.

Dietary Supplement: Probiotics prevent health problems in children

Interventions

Probiotics prevent health problems in children DIETARY_SUPPLEMENT

A controlled field trial was conducted with 1,036 children (3-5 years old) in Thanh Hoa province in Vietnam. The probiotic group (n=518) consumed fermented milk 65 mL/day containing 108 CFU/mL of LcS for the 12-week intervention period, whereas the control group (n=493) were not given any. The incidence of constipation, diarrhea, ARI, and anthropometry in children was determined at baseline, after 4, 8, and 12-week intervention and after the 4-week follow-up period.

Also known as: Yakult fermented milk

Probiotics (LcS per 65 mL) prevent health problems in children

Eligibility Criteria

• Age: 3 Years - 5 Years
• Gender Eligibility Details: The list of children was identified in the school, including female and male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Institute of Nutrition, Vietnam: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Cong Chinh, Van Thang, Dinh Thanh and Yen Thai

Thanh Hóa, Thanh Hóa Province, 84, Vietnam

Location

MeSH Terms

Conditions

Digestive System Diseases; Diarrhea; Constipation

Condition Hierarchy (Ancestors)

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

Study Officials

• Tuyen Le

  National Institute of Nutrition

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, PhD, MD

Model Details: 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.

Study Record Dates

• First Submitted: March 29, 2020
• First Posted: April 15, 2020
• Study Start: October 5, 2017
• Primary Completion: January 5, 2018
• Study Completion: June 5, 2018
• Last Updated: April 15, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)