Endoscopic Assessment and Prediction of Microbiome-modifying Interventions (microbiome)

July 18, 2017 updated by: Tel-Aviv Sourasky Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

45

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 Contact

Study Locations

  • Israel
      • Tel Aviv, Israel, 64239
        • Recruiting
        • Department of Gastroentherology
        • Contact:
        • Principal Investigator:
          • Zamir Halpern, MD
        • Sub-Investigator:
          • Niv Zmora, MD
        • Sub-Investigator:
          • Eran Elinav, M.D. Ph.D. A.
        • Sub-Investigator:
          • Eran Segal, Prof.

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No intervention
No intervention after antibiotic treatment.
Active Comparator: Probiotic microbiome rehabilitation
Probiotic treatment after antibiotic treatment.
Dietary supplement: Probiotic treatment
4 weeks of probiotic treatment after 7 days of antibiotics (Metronidazole+Ciprofloxacin)
Active Comparator: Bacteriotherapy microbiome rehabilitation
Bacteriotherapy after antibiotic treatment.
Biological: Bacteriotherapy
Bacteriotherapy (autologous fecal microbiota transplantation) after 7 days of antibiotics (Metronidazole+Ciprofloxacin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiome composition
Time Frame: 1 year
stool samples
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiome composition
Time Frame: 1 month
Gastrointestinal tract biopsies
1 month

Collaborators and Investigators

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

Sponsor

Tel-Aviv Sourasky Medical Center

Collaborators

Weizmann Institute of Science

Investigators

  • Principal Investigator: Zamir Halpern, MD, Tel-Aviv Sourasky Medical Center

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)

February 1, 2013

Primary Completion (Anticipated)

December 30, 2019

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

July 13, 2017

First Submitted That Met QC Criteria

July 13, 2017

First Posted (Actual)

July 14, 2017

Study Record Updates

Last Update Posted (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TASMC-12-ZH-658-CTIL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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