Brain Probiotic and LC-PUFA Intervention for Optimum Early Life

Summary

Probiotics is suggested to play several roles in promoting health, including alleviating disease symptoms, protection against atopic disease, and modulating the immune system by improving the beneficial gut microbiota colonization. The discovery of the gut microbiota-brain axis suggested that there is a reciprocal influence between the brain and the gut through a constant communication. This bi-directional axis enables signals to be transferred from brain to influence sensory, motor, and secretory modalities of the GI tract, also permits signal from the gut to influence brain function. The establishment of intestinal microbiota during early neurodevelopmental period suggests the colonization and maturation of gut microbiota may influence brain development. Several studies have shown there is an association between shifts in the gut microbiota composition in children with neurodevelopmental disorders. This study aims to investigate how maternal probiotic + LC-PUFA supported with government program supplements, healthy eating, and psychosocial stimulation could affect fetal brain development and later child brain functions and cognitive development. Intervention would be delivered to pregnant women for 9 months, starting at the end of second trimester of gestational period.

Conditions

• Maternal Exposure
• Health Behavior
• Infant Development
• Child Development

Interventions

DIETARY_SUPPLEMENT

Probiotics and LC-PUFA (480 mg DHA)

Probiotics and LC-PUFA (480 mg DHA)

DIETARY_SUPPLEMENT

Placebo probiotics and control LC-PUFA (120 mg DHA)

Placebo probiotics and control LC-PUFA (120 mg DHA)

BEHAVIORAL

Psychosocial stimulation and healthy eating education

Psychosocial stimulation and healthy eating education

Sponsors & Collaborators

• Grand Challenges Canada

  collaborator OTHER

• Indonesia University

  lead OTHER

Principal Investigators

• Rina Agustina, PhD · Human Nutrition Research Center, IMERI; Dep of Nutrition, Fac.of Medicine UI

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-10-31

Primary Completion

2022-08-31

Completion

2024-08-31

Countries

• Indonesia

Study Locations