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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-18

Study Completion Date

2024-12-31

Brief Summary

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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?

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Detailed Description

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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.

Conditions

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Postpartum Depression Quality of Life Functional Gastrointestinal Disorders Probiotics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Probiotics group

Will give Probiotics with Vit.D 3

Group Type EXPERIMENTAL

Probiotics group

Intervention Type DIETARY_SUPPLEMENT

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

Non-probiotics group

Will give Vit. D3 as placebo

Group Type PLACEBO_COMPARATOR

Non-probiotics group

Intervention Type DIETARY_SUPPLEMENT

Will give Vitamin D3 five drops per day for 90 days

Interventions

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Probiotics group

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

Intervention Type DIETARY_SUPPLEMENT

Non-probiotics group

Will give Vitamin D3 five drops per day for 90 days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

* Aged between 20-50 and baby included in our study

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\>

* Diagnosed as psychiatric disease during antepartum period or before pregnancy

Minimum Eligible Age

1 Day

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes