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

Buddhist Tzu Chi General Hospital

Status: Not yet enrolling

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

Treatments: Dietary Supplement: Probiotics group; Dietary Supplement: Non-probiotics group

Study type: Interventional

Funder types: Other

Identifiers

NCT04741971

P00001711

Details and patient eligibility

About

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?

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 1 day to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

<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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 2 patient groups, including a placebo group

Probiotics group

Experimental group

Description:

Will give Probiotics with Vit.D 3

Treatment:

Dietary Supplement: Probiotics group

Non-probiotics group

Placebo Comparator group

Description:

Will give Vit. D3 as placebo

Treatment:

Dietary Supplement: Non-probiotics group