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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04741971
• Other study ID #: P00001711
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Digestive System Diseases
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases
• Postpartum Depression
• Probiotics
• Quality of Life

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