## Protocol Section
### Identification Module
**NCT ID:** NCT03218579

**Acronym:** microbiome

**Brief Title:** Endoscopic Assessment and Prediction of Microbiome-modifying Interventions

**Official Title:** Endoscopic Assessment and Prediction of Microbiome-modifying Interventions

#### Organization Study ID Info
**ID:** TASMC-12-ZH-658-CTIL
#### Organization
**Class:** OTHER_GOV
**Full Name:** Tel-Aviv Sourasky Medical Center
### Status Module
#### Completion Date
**Date:** 2020-12-30

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2017-07-21

**Type:** ACTUAL

**Last Update Submit Date:** 2017-07-18

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2019-12-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2013-02-01

**Type:** ACTUAL

**Status Verified Date:** 2017-07

#### Study First Post Date
**Date:** 2017-07-14
**Type:** ACTUAL
**Study First Submit Date:** 2017-07-13
**Study First Submit QC Date:** 2017-07-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Weizmann Institute of Science

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Tel-Aviv Sourasky Medical Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Gut Microbiome

- Antibiotic Side Effect

**Keywords:**

- microbiome

- intestinal bacteria

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 45

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** No intervention after antibiotic treatment.

**Label:** No intervention

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** Probiotic treatment after antibiotic treatment.

**Intervention Names:**

- Dietary Supplement: Probiotic treatment

**Label:** Probiotic microbiome rehabilitation

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** Bacteriotherapy after antibiotic treatment.

**Intervention Names:**

- Biological: Bacteriotherapy

**Label:** Bacteriotherapy microbiome rehabilitation

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Probiotic microbiome rehabilitation

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

**Name:** Probiotic treatment

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- Bacteriotherapy microbiome rehabilitation

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

**Name:** Bacteriotherapy

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Description:** stool samples

**Measure:** Microbiome composition

**Time Frame:** 1 year

#### Secondary Outcomes

**Description:** Gastrointestinal tract biopsies

**Measure:** Microbiome composition

**Time Frame:** 1 month

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** noyah@tlvmc.gov.il

**Name:** Noya Horowitz, PhD

**Phone:** 97236974297

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Tel Aviv

**Contacts:**

***Contact 1:***

- **Email:** halpernza@tlvmc.gov.il

- **Name:** Zamir Halpern, MD

- **Phone:** 6974282

- **Role:** CONTACT

***Contact 2:***

- **Name:** Zamir Halpern, MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Niv Zmora, MD

- **Role:** SUB_INVESTIGATOR

***Contact 4:***

- **Name:** Eran Elinav, M.D. Ph.D. A.

- **Role:** SUB_INVESTIGATOR

***Contact 5:***

- **Name:** Eran Segal, Prof.

- **Role:** SUB_INVESTIGATOR

**Country:** Israel

**Facility:** Department of Gastroentherology

**Status:** RECRUITING

**Zip:** 64239

#### Overall Officials

**Official 1:**

**Affiliation:** Tel-Aviv Sourasky Medical Center

**Name:** Zamir Halpern, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M6176

- Name: Ciprofloxacin

- Relevance: LOW

- As Found: Unknown

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4224

- Name: Antibiotics, Antitubercular

- Relevance: LOW

- As Found: Unknown

- ID: M11767

- Name: Metronidazole

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
