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Gut Microbiome Associated Study of Shanghai Infants With Jaundice

Primary Purpose

Gastrointestinal Microbiome

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Probiotics
Sponsored by
Shanghai 10th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Microbiome focused on measuring Probiotics, Gut Microbiome, Infants, Jaundice

Eligibility Criteria

1 Hour - 28 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai 10th People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

blue light phototherapy

probiotics concurrent with phototherapy

Arm Description

the patients in this arm will not receive probiotics.

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

Outcomes

Primary Outcome Measures

change from birth,7 days,14 days on gut microbiome at 42 days by 16S rRNA
change of the gut microbiome will be calculated at 42 days in comparison with birth,7 days,14 days

Secondary Outcome Measures

change from birth on gut microbiome at 7 days by 16S rRNA
change of the gut microbiome will be calculated at 7 days in comparison with baseline
change from birth and 7 days on gut microbiome at 14 days by 16S rRNA
change of the gut microbiome will be calculated at 14 days in comparison with birth and 7 days

Full Information

First Posted
April 18, 2018
Last Updated
May 21, 2018
Sponsor
Shanghai 10th People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03510936
Brief Title
Gut Microbiome Associated Study of Shanghai Infants With Jaundice
Official Title
Effect of Probiotics on the Gut Mircobiome of Infants With Jaundice
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
March 1, 2019 (Anticipated)
Study Completion Date
March 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Microbiome
Keywords
Probiotics, Gut Microbiome, Infants, Jaundice

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
blue light phototherapy
Arm Type
No Intervention
Arm Description
the patients in this arm will not receive probiotics.
Arm Title
probiotics concurrent with phototherapy
Arm Type
Experimental
Arm Description
the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis for 2 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics
Intervention Description
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
Primary Outcome Measure Information:
Title
change from birth,7 days,14 days on gut microbiome at 42 days by 16S rRNA
Description
change of the gut microbiome will be calculated at 42 days in comparison with birth,7 days,14 days
Time Frame
42 days
Secondary Outcome Measure Information:
Title
change from birth on gut microbiome at 7 days by 16S rRNA
Description
change of the gut microbiome will be calculated at 7 days in comparison with baseline
Time Frame
7 days
Title
change from birth and 7 days on gut microbiome at 14 days by 16S rRNA
Description
change of the gut microbiome will be calculated at 14 days in comparison with birth and 7 days
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rong Yang, MD
Phone
13321917107
Email
leexuechun1@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Zhong
Phone
13701806709
Email
zhonghuiunique@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huanlong Qin
Organizational Affiliation
Shanghai 10th People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai 10th People's Hospital
City
Shanghai
ZIP/Postal Code
20072
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rong Yang, MD
Phone
13321917107
Email
leexuechun1@126.com
First Name & Middle Initial & Last Name & Degree
Huanlong Qin, PhD

12. IPD Sharing Statement

Learn more about this trial

Gut Microbiome Associated Study of Shanghai Infants With Jaundice

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