Endoscopic Assessment and Prediction of Microbiome-modifying Interventions

NCT ID: NCT03218579

Last Updated: 2017-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-01

Study Completion Date

2020-12-30

Brief Summary

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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

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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.

Conditions

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Gut Microbiome Antibiotic Side Effect

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No intervention

No intervention after antibiotic treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Probiotic microbiome rehabilitation

Probiotic treatment after antibiotic treatment.

Group Type ACTIVE_COMPARATOR

Probiotic treatment

Intervention Type DIETARY_SUPPLEMENT

4 weeks of probiotic treatment after 7 days of antibiotics (Metronidazole+Ciprofloxacin)

Bacteriotherapy microbiome rehabilitation

Bacteriotherapy after antibiotic treatment.

Group Type ACTIVE_COMPARATOR

Bacteriotherapy

Intervention Type BIOLOGICAL

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

Interventions

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Probiotic treatment

4 weeks of probiotic treatment after 7 days of antibiotics (Metronidazole+Ciprofloxacin)

Intervention Type DIETARY_SUPPLEMENT

Bacteriotherapy

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Weizmann Institute of Science

OTHER

Sponsor Role collaborator

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zamir Halpern, MD

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center

Locations

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Department of Gastroentherology

Tel Aviv, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Noya Horowitz, PhD

Role: CONTACT

97236974297

Facility Contacts

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Zamir Halpern, MD

Role: primary

Other Identifiers

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TASMC-12-ZH-658-CTIL

Identifier Type: -

Identifier Source: org_study_id

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