Shanghai Infants Gut Microbiome Associated Study

Effects of Probiotics on the Gut Microbiome of Infants Treated With Antibiotics

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

Study Overview

• Status: Unknown
• Conditions: Gastrointestinal Microbiome
• Intervention / Treatment: Dietary supplement: Probiotics

Detailed Description

This study aims to examin the impact of probiotics under 2 separate conditions, probiotics concurrent administration with antibiotic and probiotics administration during the recovery phase.Birth,7 days,14 days(or 21 days) and 42 days data will be collected and put into analysis to provide somes suggestions on the probiotics use in the clinical for the infants treated with antibiotics.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yang Rong, MD; Phone Number: 13321917107; Email: leexuechun1@126.com
• Study Contact Backup: Name: Hui Zhong, MD; Phone Number: 13701806709; Email: zhonghuiunique@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200072
      • Recruiting
      • Shanghai 10th People's Hospital
      • Contact: Rong Yang, MD; Phone Number: 13321917107; Email: leexuechun1@126.com

Participation Criteria

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 infectious diseases treated with antibiotic

Exclusion Criteria:

• Gestational weeks <37
• Birth weight <2500g or ≥4000g
• History of asphyxia anoxia at birth
• With congenital metabolic diseases or hereditary diseases
• With gastrointestinal diseases

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: antibiotics; the patients in this arm will not receive probiotics.
Experimental: probiotics concurrent with antibiotic; the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis for 2 weeks concurrent with antibiotic.	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
Experimental: probiotics after antibiotic; the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis for 2 weeks after antibiotic.	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(or 21 days) on gut mcrobiome at 42 days	change of the gut mcrobiome will be calculated at 42 days in comparison with birth,7 days,14 days(or 21 days)	42 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from birth on gut mcrobiome at 7 days	change of the gut mcrobiome will be calculated at 7 days in comparison with baseline	7 days
change from birth and 7 days on gut mcrobiome at 14 days(or 21 days)	change of the gut mcrobiome will be calculated at 14(or 21 days) in comparison with birth and 7 days	14 days（or 21days）

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2017
• Primary Completion (Anticipated): December 31, 2017
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: December 23, 2017
• First Submitted That Met QC Criteria: December 29, 2017
• First Posted (Actual): January 2, 2018

Study Record Updates

• Last Update Posted (Actual): January 2, 2018
• Last Update Submitted That Met QC Criteria: December 29, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Probiotics,Gut Microbiome,Antibiotics,Infants
• Other Study ID Numbers: SHSYEK2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No