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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postpartum Depression, Quality of Life, Functional Gastrointestinal Disorders, Probiotics

Intervention / Treatment
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* Dietary Supplement: Probiotics group
* Dietary Supplement: Non-probiotics group


Participation Criteria
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Eligibility Criteria
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<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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics group<br>Will give Probiotics with Vit.D 3 | Dietary Supplement: Probiotics group<br>* Will give Probiotics with Vitamin D3 one drop per day for 90 days<br>|
| Placebo Comparator: Non-probiotics group<br>Will give Vit. D3 as placebo | Dietary Supplement: Non-probiotics group<br>* Will give Vitamin D3 five drops per day for 90 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal Sleep Quality | 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. | at their child birth | 
| Maternal Sleep Quality | 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. | at their child 1-month-old | 
| Maternal Sleep Quality | 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. | at their child 3-month-old | 
| Maternal Sleep Quality | 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. | at their child 6-month-old | 
| Maternal quality of life | 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. | at their child birth | 
| Maternal quality of life | 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. | at their child 1-month-old | 
| Maternal quality of life | 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. | at their child 3-month-old | 
| Maternal quality of life | 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. | at their child 6-month-old | 
| Maternal risk of postnatal depression | 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. | at their child birth | 
| Maternal risk of postnatal depression | 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. | at their child birth 1-month-old | 
| Maternal risk of postnatal depression | 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. | at their child birth 3-month-old | 
| Maternal risk of postnatal depression | 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. | at their child birth 6-month-old | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonate and infant' condition of functional gastrointestinal disorders | Neonate and infant' condition of functional gastrointestinal disorders including infantile colic and regurgitation assessed by the questionnaires according to ROME-IV criteria, and higher score indicate worse condition of functional gastrointestinal disorders in infancy. | at baby's 1-month-old | 
| Neonate and infant' condition of functional gastrointestinal disorders | Neonate and infant' condition of functional gastrointestinal disorders including infantile colic and regurgitation assessed by the questionnaires according to ROME-IV criteria, and higher score indicate worse condition of functional gastrointestinal disorders in infancy. | at baby's 3-month-old | 
| Neonate and infant' condition of functional gastrointestinal disorders | Neonate and infant' condition of functional gastrointestinal disorders including infantile colic and regurgitation assessed by the questionnaires according to ROME-IV criteria, and higher score indicate worse condition of functional gastrointestinal disorders in infancy. | at baby's 6-month-old | 
| Neonate and infant' diaper dermatitis | Neonate and infant' diaper dermatitis assessed by the self-rated questionnaire to determine the condition of diaper dermatitis. | at baby's 1-month-old | 
| Neonate and infant' diaper dermatitis | Neonate and infant' diaper dermatitis assessed by the self-rated questionnaire to determine the condition of diaper dermatitis. | at baby's 3-month-old | 
| Neonate and infant' diaper dermatitis | Neonate and infant' diaper dermatitis assessed by the self-rated questionnaire to determine the condition of diaper dermatitis. | at baby's 6-month-old | 
| Neonate and infant' atopic dermatitis | Neonate and infant' atopic dermatitis assessed by the self-rated questionnaire to determine the condition of atopic dermatitis | at baby's 1-month-old | 
| Neonate and infant' atopic dermatitis | Neonate and infant' atopic dermatitis assessed by the self-rated questionnaire to determine the condition of atopic dermatitis | at baby's 3-month-old | 
| Neonate and infant' atopic dermatitis | Neonate and infant' atopic dermatitis assessed by the self-rated questionnaire to determine the condition of atopic dermatitis | at baby's 6-month-old | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum Depression, Probiotics, infantile colic