Postpartum DepressionNCT04741971
Whether Probiotics Use in Neonate and Infant Improve Their Mother's Life Quality
A study testing Probiotics group and Non-probiotics group in people with Postpartum Depression and Quality of Life, run by Buddhist Tzu Chi General Hospital.
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… Read more about this study
- Who is it for?
- Ages 1 day to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression, Quality of Life, Functional Gastrointestinal Disorders
- What is being tested?
- Probiotics group and Non-probiotics group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 18 Feb 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
- Aged between 20-50 and baby included in our study
Who cannot join
- Congenital disorders and/or clinical or physical alterations at clinical examination
- Antibiotic or probiotic administration before inclusion
- Admission to ICU
- <Participants of neonates' mother>
- Diagnosed as psychiatric disease during antepartum period or before pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
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?
Read the 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.
- Being tested
- Probiotics group, Non-probiotics group
- Keywords
- Postpartum Depression, Probiotics, infantile colic
- Medical subject headings
- Depression, Postpartum, Gastrointestinal Diseases, Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics groupDietary supplement
Will give Probiotics with Vitamin D3 one drop per day for 90 days
Non-probiotics groupDietary supplement
Will give Vitamin D3 five drops per day for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Probiotics group | Experimental | Will give Probiotics with Vit.D 3 Receives: Dietary Supplement: Probiotics group |
| Non-probiotics group | Placebo comparator | Will give Vit. D3 as placebo Receives: Dietary Supplement: Non-probiotics group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at their child birth 6-month-old
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: at baby's 6-month-old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start18 Feb 2021 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Chao Hsiao, Buddhist Tzu Chi General Hospital
- Investigators
- Yu-Hsun Chang, Study chair, Department of Pediatrics, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation,Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741971
- Sponsor's protocol ID
- P00001711
- Status last verified
- Feb 2021
- First submitted
- 12 Jan 2021
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will share all IPD
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whether Probiotics Use in Neonate and Infant Improve Their Mother's Life Quality
- ClinicalTrials.gov ID
- NCT04741971
- Acronym / sponsor ID
- P00001711
- Keywords
- Postpartum Depression, Probiotics, infantile colic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 18 Feb 2021 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics group | Experimental | Dietary Supplement: Probiotics groupWill give Probiotics with Vit.D 3 |
| Non-probiotics group | Placebo comparator | Dietary Supplement: Non-probiotics groupWill give Vit. D3 as placebo |
Who may qualify
- Ages
- 1 day to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
- Aged between 20-50 and baby included in our study
Key exclusion criteria (5 listed)
- Congenital disorders and/or clinical or physical alterations at clinical examination
- Antibiotic or probiotic administration before inclusion
- Admission to ICU
- <Participants of neonates' mother>
- Diagnosed as psychiatric disease during antepartum period or before pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotics groupWill give Probiotics with Vitamin D3 one drop per day for 90 days | Dietary supplement | Probiotics group |
| Non-probiotics groupWill give Vitamin D3 five drops per day for 90 days | Dietary supplement | Non-probiotics group |
Primary outcome
Maternal Sleep Quality
Time frame: at their child birth
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
Time frame: at their child 1-month-old
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
Time frame: at their child 3-month-old
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
Time frame: at their child 6-month-old
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
Time frame: at their child birth
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
Time frame: at their child 1-month-old
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
Time frame: at their child 3-month-old
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
Time frame: at their child 6-month-old
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
Time frame: at their child birth
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
Time frame: at their child birth 1-month-old
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
Time frame: at their child birth 3-month-old
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
Time frame: at their child birth 6-month-old
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.
9 secondary outcomes
Neonate and infant' condition of functional gastrointestinal disorders
Time frame: at baby's 1-month-old
Neonate and infant' condition of functional gastrointestinal disorders
Time frame: at baby's 3-month-old
Neonate and infant' condition of functional gastrointestinal disorders
Time frame: at baby's 6-month-old
Neonate and infant' diaper dermatitis
Time frame: at baby's 1-month-old
Neonate and infant' diaper dermatitis
Time frame: at baby's 3-month-old
Neonate and infant' diaper dermatitis
Time frame: at baby's 6-month-old
Neonate and infant' atopic dermatitis
Time frame: at baby's 1-month-old
Neonate and infant' atopic dermatitis
Time frame: at baby's 3-month-old
Neonate and infant' atopic dermatitis
Time frame: at baby's 6-month-old
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Individual participant dataSharing planned: Yes. Will share all IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Hsun Chang study chair
Department of Pediatrics, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation,Taiwan
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics group and Non-probiotics group in people with Postpartum Depression and Quality of Life, run by Buddhist Tzu Chi General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Chao Hsiao (886-3-8561825 ext. 12777, u9602041@cmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Sleep Quality (time frame: at their child birth). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.