Endoscopic Assessment and Prediction of Microbiome-modifying Interventions

Not Applicable

• Conditions: Antibiotic Side Effect; Gut Microbiome
• Interventions: Biological: Bacteriotherapy; Dietary Supplement: Probiotic treatment

• Registration Number: NCT03218579
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

The investigators would like to examine the extent of gut microbiome rehabilitation in healthy people after the consumption of antibiotics.

Outcomes of probiotic treatment versus bacteriotherapy will be compared.

Detailed Description

The investigators would like to examine the extent of rehabilitation of the composition and functioning of the intestinal bacteria in healthy people after the consumption of antibiotics.

Since the digestive mocus enables the connection between the host and the bacteria that live within it, the investigators would like to characterize the microbiome in the different areas along the digestive system - before antibiotic treatment and after rehabilitation by probiotic treatment versus bacteriotherapy.

Study Timeline

• Study Start: 2013-02-01
• Status Verified: 2017-07
• Study First Submitted: 2017-07-13
• Study First Submitted QC: 2017-07-13
• Study First Posted: 2017-07-14
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-21
• Primary Completion: 2019-12-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Healthy volunteers
• Age: 18 years and up
• Gender: women and men

Exclusion Criteria

• Pregnancy
• Age under 18 years
• antibiotic treatment 3 months prior to enrollment
• Viral Hepatitis
• HIV positive

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bacteriotherapy microbiome rehabilitation	Bacteriotherapy	Bacteriotherapy after antibiotic treatment.
Probiotic microbiome rehabilitation	Probiotic treatment	Probiotic treatment after antibiotic treatment.

Primary Outcome Measures

Name	Time	Method
Microbiome composition	1 year	stool samples

Secondary Outcome Measures

Name	Time	Method
Microbiome composition	1 month	Gastrointestinal tract biopsies

Trial Locations

Locations (1)

Department of Gastroentherology; 🇮🇱 Tel Aviv, Israel