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

NCT04741971 | Unknown DMC

• 1 other identifier: P00001711
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

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?

Conditions

Postpartum Depression; Quality of Life; Functional Gastrointestinal Disorders; Probiotics

Keywords

Postpartum Depression; Probiotics; infantile colic

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (9)

• Neonate and infant' condition of functional gastrointestinal disorders

  at baby's 1-month-old

• Neonate and infant' condition of functional gastrointestinal disorders

  at baby's 3-month-old

• Neonate and infant' condition of functional gastrointestinal disorders

  at baby's 6-month-old

• Neonate and infant' diaper dermatitis

  at baby's 1-month-old

• Neonate and infant' diaper dermatitis

  at baby's 3-month-old

Study Arms (2)

Probiotics group

EXPERIMENTAL

Will give Probiotics with Vit.D 3

Dietary Supplement: Probiotics group

Non-probiotics group

PLACEBO COMPARATOR

Will give Vit. D3 as placebo

Dietary Supplement: Non-probiotics group

Interventions

Probiotics group DIETARY_SUPPLEMENT

Will give Probiotics with Vitamin D3 one drop per day for 90 days

Probiotics group

Non-probiotics group DIETARY_SUPPLEMENT

Will give Vitamin D3 five drops per day for 90 days

Non-probiotics group

Eligibility Criteria

• Age: 1 Day - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Congenital disorders and/or clinical or physical alterations at clinical examination
• Admission to ICU
• \<Participants of neonates' mother\>
• Aged between 20-50 and baby included in our study
• Diagnosed as psychiatric disease during antepartum period or before pregnancy

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

MeSH Terms

Conditions

Depression, Postpartum; Gastrointestinal Diseases; Colic

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Digestive System Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Yu-Hsun Chang

  Department of Pediatrics, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation,Taiwan

  STUDY CHAIR

Central Study Contacts

Yu-Chao Hsiao

CONTACT

886-3-8561825; u9602041@cmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: February 5, 2021
• Study Start: February 18, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 5, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: May be on December 2024
• Access Criteria: Will be published