Gut Microbiome Associated Study of Shanghai Infants With Jaundice

NCT ID: NCT03510936

Last Updated: 2018-05-23

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-03-01

Brief Summary

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The purpose of this study is to evaluate the effect of probiotics on the gut microbiome of infants with jaundice.

Detailed Description

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This study aims to examin the impact of probiotics administration during the process of infants jaundice treatment and recovery phase.the recovery phase.Birth,7 days,14 days and 42 days data will be collected and put into analysis to provide some suggestions on the probiotics use in the clinical for the infants with jaundice.

Conditions

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Gastrointestinal Microbiome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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blue light phototherapy

the patients in this arm will not receive probiotics.

Group Type NO_INTERVENTION

No interventions assigned to this group

probiotics concurrent with phototherapy

the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis for 2 weeks

Group Type EXPERIMENTAL

Probiotics

Intervention Type DIETARY_SUPPLEMENT

the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis with does of 1.5\*10\^7CFU for 2 weeks

Interventions

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Probiotics

the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis with does of 1.5\*10\^7CFU for 2 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Newborns with jaundice treated with blue light phototherapy

Exclusion Criteria

* Gestational weeks \<37 Birth weight \<2500g or ≥4000g History of asphyxia anoxia at birth With infectious diseases treated with antibiotic With congenital metabolic diseases or hereditary diseases With gastrointestinal diseases
Minimum Eligible Age

1 Hour

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Huanlong Qin

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Huanlong Qin

Role: PRINCIPAL_INVESTIGATOR

Shanghai 10th People's Hospital

Locations

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Shanghai 10th People's Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Rong Yang, MD

Role: CONTACT

13321917107

Hui Zhong

Role: CONTACT

13701806709

Facility Contacts

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Rong Yang, MD

Role: primary

13321917107

Other Identifiers

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SHSYEK2018

Identifier Type: -

Identifier Source: org_study_id

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