Whether Probiotics Use in Neonate and Infant Improve Their Mother's Life Quality
Phase: NA
Conditions: Postpartum Depression, Quality of Life, Functional Gastrointestinal Disorders, Probiotics
Sponsor: Buddhist Tzu Chi General Hospital

Official Title:  
Whether Probiotics Use in Neonate and Infant 
Improve Their Mother's Life Quality? 
NCT number:  
Not available 
Document Date:  
January 29, 2021 
 
 
 

 
Title 
Whether Probiotics Use in Neonate and Infant Improve Their Mother's Life Quality? 
Sponsor/Collaborators 
Sponsor: Buddhist Tzu Chi General Hospital   
Responsible Party: 
Principal Investigator 
Investigator: Yu-Chao Hsiao  
Affiliation: Buddhist Tzu Chi General Hospital 
Human Subjects Review 
Board Status: Approved     Approval Number: IRB109-247-A 
Board Name: Research Ethics Committee, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical 
Foundation 
Board Affiliation: 
 Research Ethics Committee, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation 
Phone: 886-3-8561825   Ext: 13272    Email: IRB@tzuchi.com.tw 
Address: 707,Sec.3,Chung-Yang Rd., Hualien, 97002,Taiwan 
Study description 
 
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, our study aimed to investigate whether probiotics use in 
neonate and infant improve their mother's life quality? 
Study design 
Study Type: Interventional  Primary Purpose: 
Prevention 
Study Phase: N/A  Interventional Study Model: Parallel Assignment 

Number of Arms: 
2 
Experimental: Probiotics group 
Will give Probiotics with Vitamin D3 one drop per day for 90 days 
Placebo Comparator: Non-probiotics group 
Will give Vitamin D3 as placebo five drops per day for 90 days 
Masking: Single (Participant) 
Allocation: Randomized 
Enrollment: 220   
We use G-power (edition 3.1.9.7) to calculate case numbers with type I erro:5% , type II erro:20%, 
and dropout rate: 10%. Each group will be 110 participants (total 220 participants). 
Outcome measures: 
Primary Outcome Measure: 
1.Maternal quality of life 
Maternal quality of life 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. 
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. 
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. 
[Time Frame: at their child birth] 
2.Maternal quality of life 
Maternal quality of life 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. 

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. 
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. 
[Time Frame: at their child 1-month-old] 
3.Maternal quality of life 
Maternal quality of life 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. 
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. 
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. 
[Time Frame: at their child 3-month-old] 
4.Maternal quality of life 
Maternal quality of life 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. 
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. 
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. 
[Time Frame: at their child 6-month-old] 

Secondary Outcome Measures: 
 
Neonate and infant' health condition 
Neonate and infant' health conditions including functional gastrointestinal disorders, diaper dermatitis, 
and atopic dermatitis. 
 
Functional Gastrointestinal Disorders in Infancy including infantile colic and regurgitation: use 
questionnaires according to ROME-IV criteria, and higher score indicate worse condition of functional 
gastrointestinal disorders in infancy. 
Diaper dermatitis: use a self-rated questionnaire to determine the condition of diaper dermatitis 
Atopic dermatitis: use a self-rated questionnaire to determine the condition of atopic dermatitis 
[Time Frame: at baby's 1-month-old] 
Neonate and infant' health condition 
Neonate and infant' health conditions including functional gastrointestinal disorders, diaper dermatitis, 
and atopic dermatitis. 
 
Functional Gastrointestinal Disorders in Infancy including infantile colic and regurgitation: use 
questionnaires according to ROME-IV criteria, and higher score indicate worse condition of functional 
gastrointestinal disorders in infancy. 
Diaper dermatitis: use a self-rated questionnaire to determine the condition of diaper dermatitis 
Atopic dermatitis: use a self-rated questionnaire to determine the condition of atopic dermatitis 
[Time Frame: at baby's 3-month-old] 
Neonate and infant' health condition 
Neonate and infant' health conditions including functional gastrointestinal disorders, diaper dermatitis, 
and atopic dermatitis. 
 
Functional Gastrointestinal Disorders in Infancy including infantile colic and regurgitation: use 
questionnaires according to ROME-IV criteria, and higher score indicate worse condition of functional 
gastrointestinal disorders in infancy. 
Diaper dermatitis: use a self-rated questionnaire to determine the condition of diaper dermatitis 
Atopic dermatitis: use a self-rated questionnaire to determine the condition of atopic dermatitis 
[Time Frame: at baby's 6-month-old] 
 

Eligibility 
Baby’s Age: 1-day-old to 7-day-old   
Mother’s Age: 
20 to 50-year-old   
Baby’s Sex: All   
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: 
(1) Aged between 20-50 and baby included in our study 
Exclusion Criteria: 
(1) Diagnosed as psychiatric disease during antepartum period or before pregnancy 
Study protocol 
 
Infant participants who meet the inclusion criteria will be included, and they will be categorized 
randomly into experimental group or placebo group. Experimental group will be given experimental agent 
including vitamin D3 and probiotics for total 90 days. Placebo group will be given placebo agent including 
vitamin D3 for total 90 days. We will also record infant’s birth record at the same time. For both groups, 
we will ask infant participant’s mother about baby’s health condition and maternal quality of life by using 
PSQI, WHOQOL, and Edinburgh Postnatal Depression Scale at the timing of their baby’s birth, at baby's 1-
month-old, baby's 3-month-old, and baby's 6-month-old. 
Statistical analysis 
  Demographic data, maternal life quality, and infant’s health condition will be presented as mean ± 
standard deviation, median , or percentile. Independent-Sample t test and hi-square test was performed to 
evaluate the associations between probiotics use and maternal lift quality and infant’s health condition. 
Statistical significance was defined as p value <0.05. All statistical analyses were performed with Statistical 
Analysis System, Statistical Package for the Social Sciences or Statistics with R .