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Gut Microbiome Associated Study of Shanghai Infants With Jaundice

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ClinicalTrials.gov Identifier: NCT03510936
Recruitment Status : Recruiting
First Posted : April 27, 2018
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Huanlong Qin, Shanghai 10th People's Hospital

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

Condition or disease Intervention/treatment Phase
Gastrointestinal Microbiome Dietary Supplement: Probiotics Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Probiotics on the Gut Mircobiome of Infants With Jaundice
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : March 1, 2019

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03510936


Contacts
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Contact: Rong Yang, MD 13321917107 leexuechun1@126.com
Contact: Hui Zhong 13701806709 zhonghuiunique@126.com

Locations
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China
Shanghai 10th People's Hospital Recruiting
Shanghai, China, 20072
Contact: Rong Yang, MD    13321917107    leexuechun1@126.com   
Principal Investigator: Huanlong Qin, PhD         
Sponsors and Collaborators
Shanghai 10th People's Hospital
Investigators
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Principal Investigator: Huanlong Qin Shanghai 10th People's Hospital

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Responsible Party: Huanlong Qin, Director, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT03510936     History of Changes
Other Study ID Numbers: SHSYEK2018
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018

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

Keywords provided by Huanlong Qin, Shanghai 10th People's Hospital:
Probiotics
Gut Microbiome
Infants
Jaundice

Additional relevant MeSH terms:
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Jaundice
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms