NCT04741971

Whether Probiotics Use in Neonate and Infant Improve Their Mother's Life Quality

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Buddhist Tzu Chi General Hospital · Academic / Other
• Sex: All
• Age: 1 Day – 50 Years
• Healthy volunteers: Accepted

Summary

Postpartum depression and poor quality of life during postpartum were an vital issue in recent years. Infant's health condition was thought to be a possible reasons related mother's postpartum quality of life, and functional gastrointestinal disorders such as infantile colic and regurgitation were common problem during infant period. Previous study revealed that probiotics may improve the infant's discomfort caused by functional gastrointestinal disorders. Thus, this study aimed to investigate whether probiotics use in neonate and infant improve their mother's life quality?

Detailed description

This is single blinded intervention study. The investigators will invite mother to participate in the project after giving birth. At week 0, mother who meet the eligibility criteria will be randomized in a single-blind study in a 1:1 ratio to probiotics with Vit. D3 (five drops per day) or Vit. D3 (placebo) (single drop per day) for 90 days. The follow-up will be at the 1, 3 and 6 months all the subjects.

Conditions

• Postpartum Depression
• Quality of Life
• Functional Gastrointestinal Disorders
• Probiotics

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotics group	Will give Probiotics with Vitamin D3 one drop per day for 90 days
DIETARY_SUPPLEMENT	Non-probiotics group	Will give Vitamin D3 five drops per day for 90 days

Timeline

• Start date: 2021-02-18
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2021-02-05
• Last updated: 2021-02-05