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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics group | Experimental | Will give Probiotics with Vit.D 3 |
|
| Non-probiotics group | Placebo Comparator | Will give Vit. D3 as placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics group | Dietary Supplement | Will give Probiotics with Vitamin D3 one drop per day for 90 days |
|
| 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 |
| 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 |
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<Participants of neonates>
Inclusion Criteria :
Exclusion Criteria:
<Participants of neonates' mother>
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu-Chao Hsiao | Contact | 886-3-8561825 | 12777 | u9602041@cmu.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Yu-Hsun Chang | Department of Pediatrics, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation,Taiwan | Study Chair |
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Will share all IPD
May be on December 2024
Will be published
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 1, 2021 | Jan 29, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| D005767 | Gastrointestinal Diseases |
| D003085 | Colic |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Non-probiotics group | Dietary Supplement | Will give Vitamin D3 five drops per day for 90 days |
|
| 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 |
| 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 |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D004066 | Digestive System Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |