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

Primary Purpose

Postpartum Depression, Quality of Life, Functional Gastrointestinal Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Probiotics group
Non-probiotics group
Sponsored by
Buddhist Tzu Chi General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Depression focused on measuring Postpartum Depression, Probiotics, infantile colic

Eligibility Criteria

1 Day - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

<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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Probiotics group

    Non-probiotics group

    Arm Description

    Will give Probiotics with Vit.D 3

    Will give Vit. D3 as placebo

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    Neonate and infant' diaper dermatitis
    Neonate and infant' diaper dermatitis assessed by the self-rated questionnaire to determine the condition of diaper dermatitis.
    Neonate and infant' diaper dermatitis
    Neonate and infant' diaper dermatitis assessed by the self-rated questionnaire to determine the condition of diaper dermatitis.
    Neonate and infant' diaper dermatitis
    Neonate and infant' diaper dermatitis assessed by the self-rated questionnaire to determine the condition of diaper dermatitis.
    Neonate and infant' atopic dermatitis
    Neonate and infant' atopic dermatitis assessed by the self-rated questionnaire to determine the condition of atopic dermatitis
    Neonate and infant' atopic dermatitis
    Neonate and infant' atopic dermatitis assessed by the self-rated questionnaire to determine the condition of atopic dermatitis
    Neonate and infant' atopic dermatitis
    Neonate and infant' atopic dermatitis assessed by the self-rated questionnaire to determine the condition of atopic dermatitis

    Full Information

    First Posted
    January 12, 2021
    Last Updated
    February 4, 2021
    Sponsor
    Buddhist Tzu Chi General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04741971
    Brief Title
    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

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 18, 2021 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Buddhist Tzu Chi General Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postpartum Depression, Quality of Life, Functional Gastrointestinal Disorders, Probiotics
    Keywords
    Postpartum Depression, Probiotics, infantile colic

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    220 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Probiotics group
    Arm Type
    Experimental
    Arm Description
    Will give Probiotics with Vit.D 3
    Arm Title
    Non-probiotics group
    Arm Type
    Placebo Comparator
    Arm Description
    Will give Vit. D3 as placebo
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Probiotics group
    Intervention Description
    Will give Probiotics with Vitamin D3 one drop per day for 90 days
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Non-probiotics group
    Intervention Description
    Will give Vitamin D3 five drops per day for 90 days
    Primary Outcome Measure Information:
    Title
    Maternal Sleep Quality
    Description
    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.
    Time Frame
    at their child birth
    Title
    Maternal Sleep Quality
    Description
    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.
    Time Frame
    at their child 1-month-old
    Title
    Maternal Sleep Quality
    Description
    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.
    Time Frame
    at their child 3-month-old
    Title
    Maternal Sleep Quality
    Description
    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.
    Time Frame
    at their child 6-month-old
    Title
    Maternal quality of life
    Description
    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.
    Time Frame
    at their child birth
    Title
    Maternal quality of life
    Description
    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.
    Time Frame
    at their child 1-month-old
    Title
    Maternal quality of life
    Description
    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.
    Time Frame
    at their child 3-month-old
    Title
    Maternal quality of life
    Description
    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.
    Time Frame
    at their child 6-month-old
    Title
    Maternal risk of postnatal depression
    Description
    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.
    Time Frame
    at their child birth
    Title
    Maternal risk of postnatal depression
    Description
    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.
    Time Frame
    at their child birth 1-month-old
    Title
    Maternal risk of postnatal depression
    Description
    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.
    Time Frame
    at their child birth 3-month-old
    Title
    Maternal risk of postnatal depression
    Description
    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.
    Time Frame
    at their child birth 6-month-old
    Secondary Outcome Measure Information:
    Title
    Neonate and infant' condition of functional gastrointestinal disorders
    Description
    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.
    Time Frame
    at baby's 1-month-old
    Title
    Neonate and infant' condition of functional gastrointestinal disorders
    Description
    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.
    Time Frame
    at baby's 3-month-old
    Title
    Neonate and infant' condition of functional gastrointestinal disorders
    Description
    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.
    Time Frame
    at baby's 6-month-old
    Title
    Neonate and infant' diaper dermatitis
    Description
    Neonate and infant' diaper dermatitis assessed by the self-rated questionnaire to determine the condition of diaper dermatitis.
    Time Frame
    at baby's 1-month-old
    Title
    Neonate and infant' diaper dermatitis
    Description
    Neonate and infant' diaper dermatitis assessed by the self-rated questionnaire to determine the condition of diaper dermatitis.
    Time Frame
    at baby's 3-month-old
    Title
    Neonate and infant' diaper dermatitis
    Description
    Neonate and infant' diaper dermatitis assessed by the self-rated questionnaire to determine the condition of diaper dermatitis.
    Time Frame
    at baby's 6-month-old
    Title
    Neonate and infant' atopic dermatitis
    Description
    Neonate and infant' atopic dermatitis assessed by the self-rated questionnaire to determine the condition of atopic dermatitis
    Time Frame
    at baby's 1-month-old
    Title
    Neonate and infant' atopic dermatitis
    Description
    Neonate and infant' atopic dermatitis assessed by the self-rated questionnaire to determine the condition of atopic dermatitis
    Time Frame
    at baby's 3-month-old
    Title
    Neonate and infant' atopic dermatitis
    Description
    Neonate and infant' atopic dermatitis assessed by the self-rated questionnaire to determine the condition of atopic dermatitis
    Time Frame
    at baby's 6-month-old

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Day
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yu-Chao Hsiao
    Phone
    886-3-8561825
    Ext
    12777
    Email
    u9602041@cmu.edu.tw
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yu-Hsun Chang
    Organizational Affiliation
    Department of Pediatrics, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation,Taiwan
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Will share all IPD
    IPD Sharing Time Frame
    May be on December 2024
    IPD Sharing Access Criteria
    Will be published

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