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

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life; Postpartum Depression; Functional Gastrointestinal Disorders; Probiotics
• Intervention / Treatment: Dietary supplement: Probiotics group; Dietary supplement: Non-probiotics group

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.

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yu-Chao Hsiao; Phone Number: 12777 886-3-8561825; Email: u9602041@cmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

<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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Buddhist Tzu Chi General Hospital
• Investigators: Study Chair: Yu-Hsun Chang, Department of Pediatrics, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation,Taiwan

Study record dates

Study Major Dates

• Study Start (Anticipated): February 18, 2021
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Postpartum Depression; Probiotics; infantile colic
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depressive Disorder; Depression; Depression, Postpartum; Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: P00001711

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Will share all IPD
• IPD Sharing Time Frame: May be on December 2024
• IPD Sharing Access Criteria: Will be published
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No