Whether Probiotics Use in Neonate and Infant Improve Their Mother's Life Quality
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 220
- Primary Endpoint
- Maternal Sleep Quality
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 1 Day to 50 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •\ Inclusion Criteria :
- •* Gestational age more than 37 to less than 41 weeks
- •* Age less than 1 week on entry into the study
- •* Birth weight adequate for gestational age
- •* Apgar score of more than 8 at 10 minutes
Exclusion Criteria
- •* Congenital disorders and/or clinical or physical alterations at clinical examination
- •* Antibiotic or probiotic administration before inclusion
- •* Admission to ICU
- •\ Inclusion Criteria:
- •* Aged between 20-50 and baby included in our study
- •Exclusion Criteria:
- •* Diagnosed as psychiatric disease during antepartum period or before pregnancy
Outcomes
Primary Outcomes
Maternal Sleep Quality
Time Frame: at their child 6-month-old
Maternal Sleep Quality assessed by the Pittsburgh Sleep Quality Index (PSQI): a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. In scoring the PSQI, there are seven component scores with each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce total score (range 0 to 21). Higher scores indicate worse sleep quality.
Maternal quality of life
Time Frame: at their child 6-month-old
Maternal quality of life assessed by World Health Organization Quality of Life (WHOQOL) questionnaire - Brief, Taiwan version: a questionnaire including 28 items with each score 0-4. Higher score indicate better quality of life.
Maternal risk of postnatal depression
Time Frame: at their child birth 6-month-old
Maternal risk of postnatal depression assessed by Edinburgh Postnatal Depression Scale: a set of 10 screening questions with each score 0 to 3 that can indicate whether a parent has symptoms that are common in women with depression and anxiety during pregnancy and in the year following the birth of a child. Higher score indicate higher risk of postnatal depression.
Secondary Outcomes
- Neonate and infant' condition of functional gastrointestinal disorders(at baby's 6-month-old)
- Neonate and infant' diaper dermatitis(at baby's 6-month-old)
- Neonate and infant' atopic dermatitis(at baby's 6-month-old)
Investigators
Yu-Chao Hsiao
Co-Principal Investigator
Buddhist Tzu Chi General Hospital