NCT04046289

Effects of Probiotics and Calcium Supplementation on Growth, Development, and Metabolic Parameters

Effects of 6-Month Probiotics and Calcium Supplementation During Childhood on Growth, Development, and Metabolic Parameters in Adolescents: A 10-Year Follow-up Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 238 (actual)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 11 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

Stunting is still a major problem in developing countries, including Indonesia, and has been associated with impaired development. Stunted children have also a higher risk of metabolic syndrome in adulthood. The gut microbiota, as a part of intestinal integrity, may promote intake of nutrient during childhood. Probiotics supplementation may optimize the balance of gut microbiota and further improve child growth during the window period. Furthermore, calcium could also improve child growth by increasing the resistance to intestinal infection. However, the long-term effects of gut microbiota optimization during childhood using probiotics and calcium on growth, development, and the metabolic condition has not widely studied.

Detailed description

This study was a 10-year follow-up study of randomized controlled trials of 6-month probiotics and calcium supplementation of Lactobacillus reuteri DSM 17938 or Lactobacillus casei CRL 431 in children aged 1-6 years (n=494) living in urban low socioeconomic communities of East Jakarta in 2007-2008. We re-enrolled the subjects to assess the long-term effects of probiotics and calcium supplementation on growth, development, and metabolic parameters at the age of 11-17 years. Healthy children (n = 238) were included in this follow-up study. Each subject previously assigned to one intervention group: low-lactose milk with a low calcium content (LC = 53), a regular calcium content (RC = 70), regular calcium with L. reuteri DSM 17938 (n = 55), and regular calcium with L. casei CRL 431 (n = 60). Anthropometric measurements were performed by measuring the weight and height of the subjects, and further combining the results to report BMI-for-age z-score. Height was also plotted to the chart of the World Health Organization (WHO) Child Growth Standards. Gut integrity was assessed with the lactulose-mannitol ratio using high-performance liquid chromatography (HPLC) method. Cognitive function, symptoms related to depression, behaviour, and serum brain-derived neurotrophic factors (BDNF) of the adolescents were evaluated used to investigate the effects of supplementation on development. We quantified lipid profile and Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) as metabolic parameters using the vein blood sample. The metabolic parameters were measured in at least three groups of intervention.

Conditions

• Stunting
• Obesity
• Cognitive Function 1, Social
• Depression
• Behavior
• Dyslipidemias
• Insulin Resistance
• Permeability; Increased

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Low Calcium Milk	50 mg calcium/day
DIETARY_SUPPLEMENT	Regular Calcium Milk	400 mg/day
DIETARY_SUPPLEMENT	Probiotic 1	regular calcium milk + probiotic
DIETARY_SUPPLEMENT	Probiotic 2	regular calcium milk + probiotic

Timeline

• Start date: 2019-01-26
• Primary completion: 2019-03-03
• Completion: 2019-07-05
• First posted: 2019-08-06
• Last updated: 2019-08-07

Locations

1 site across 1 country: Indonesia