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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04741971
Other study ID # P00001711
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 18, 2021
Est. completion date December 31, 2024

Study information

Verified date February 2021
Source Buddhist Tzu Chi General Hospital
Contact Yu-Chao Hsiao
Phone 886-3-8561825
Email u9602041@cmu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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?


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 220
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 50 Years
Eligibility <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

Study Design


Intervention

Dietary Supplement:
Probiotics group
Will give Probiotics with Vitamin D3 one drop per day for 90 days
Non-probiotics group
Will give Vitamin D3 five drops per day for 90 days

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Buddhist Tzu Chi General Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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