Clinical trial NCT04741971: Whether Probiotics Use in Neonate and Infant Improve Their Mother's Life Quality
Official title: Whether Probiotics Use in Neonate and Infant Improve Their Mother's Life Quality
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postpartum Depression
Quality of Life
Functional Gastrointestinal Disorders
Probiotics
Keywords: Postpartum Depression
Probiotics
infantile colic
Lead sponsor: Buddhist Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 220
Sex: ALL
Minimum age (years): 1
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: \<Participants of neonates\>

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

\<Participants of neonates' mother\>

Inclusion Criteria:

* Aged between 20-50 and baby included in our study

Exclusion Criteria:

* Diagnosed as psychiatric disease during antepartum period or before pregnancy

Primary outcomes:
measure: Maternal Sleep Quality
timeFrame: at their child birth
measure: Maternal Sleep Quality
timeFrame: at their child 1-month-old
measure: Maternal Sleep Quality
timeFrame: at their child 3-month-old
measure: Maternal Sleep Quality
timeFrame: at their child 6-month-old
measure: Maternal quality of life
timeFrame: at their child birth
measure: Maternal quality of life
timeFrame: at their child 1-month-old
measure: Maternal quality of life
timeFrame: at their child 3-month-old
measure: Maternal quality of life
timeFrame: at their child 6-month-old
measure: Maternal risk of postnatal depression
timeFrame: at their child birth
measure: Maternal risk of postnatal depression
timeFrame: at their child birth 1-month-old
measure: Maternal risk of postnatal depression
timeFrame: at their child birth 3-month-old
measure: Maternal risk of postnatal depression
timeFrame: at their child birth 6-month-old
Secondary outcomes:
measure: Neonate and infant' condition of functional gastrointestinal disorders
timeFrame: at baby's 1-month-old
measure: Neonate and infant' condition of functional gastrointestinal disorders
timeFrame: at baby's 3-month-old
measure: Neonate and infant' condition of functional gastrointestinal disorders
timeFrame: at baby's 6-month-old
measure: Neonate and infant' diaper dermatitis
timeFrame: at baby's 1-month-old
measure: Neonate and infant' diaper dermatitis
timeFrame: at baby's 3-month-old
measure: Neonate and infant' diaper dermatitis
timeFrame: at baby's 6-month-old
measure: Neonate and infant' atopic dermatitis
timeFrame: at baby's 1-month-old
measure: Neonate and infant' atopic dermatitis
timeFrame: at baby's 3-month-old
measure: Neonate and infant' atopic dermatitis
timeFrame: at baby's 6-month-old
Other outcomes:
Locations:
Study officials:
affiliation: Department of Pediatrics, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation,Taiwan
name: Yu-Hsun Chang
role: STUDY_CHAIR
References: