Endoscopic Assessment and Prediction of Microbiome-modifying Interventions

Gut Microbiome Clinical Trial

— microbiome  

Official title:

Endoscopic Assessment and Prediction of Microbiome-modifying Interventions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03218579
• Other study ID #: TASMC-12-ZH-658-CTIL
• Status: Recruiting
• Phase: N/A
• First received: July 13, 2017
• Last updated: July 18, 2017
• Start date: February 1, 2013
• Est. completion date: December 30, 2020

Study information

• Verified date: July 2017
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Noya Horowitz, PhD
• Phone: 97236974297
• Email: noyah[@]tlvmc.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Side Effect
• Gut Microbiome

Intervention

Dietary Supplement:
• Probiotic treatment
4 weeks of probiotic treatment after 7 days of antibiotics (Metronidazole+Ciprofloxacin)

Biological:
• Bacteriotherapy
Bacteriotherapy (autologous fecal microbiota transplantation) after 7 days of antibiotics (Metronidazole+Ciprofloxacin)

Locations

Country	Name	City	State
Israel	Department of Gastroentherology	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center	Weizmann Institute of Science

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiome composition	stool samples	1 year
Secondary	Microbiome composition	Gastrointestinal tract biopsies	1 month