Gut Microbiome Associated Study of Shanghai Infants With Jaundice

May 21, 2018 updated by: Huanlong Qin, Shanghai 10th People's Hospital

Effect of Probiotics on the Gut Mircobiome of Infants With Jaundice

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 20072
        • Recruiting
        • Shanghai 10th People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 hour to 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: blue light phototherapy
the patients in this arm will not receive probiotics.
Experimental: probiotics concurrent with phototherapy
the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis for 2 weeks
Dietary supplement: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 10th People's Hospital

Investigators

  • Principal Investigator: Huanlong Qin, Shanghai 10th People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

April 18, 2018

First Submitted That Met QC Criteria

April 18, 2018

First Posted (Actual)

April 27, 2018

Study Record Updates

Last Update Posted (Actual)

May 23, 2018

Last Update Submitted That Met QC Criteria

May 21, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHSYEK2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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