NCT03218579

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

6.9 years

First QC Date

July 13, 2017

Last Update Submit

July 18, 2017

Conditions

Gut MicrobiomeAntibiotic Side Effect

Keywords

microbiomeintestinal bacteria

Outcome Measures

Primary Outcomes (1)

  • Microbiome composition

    stool samples

    1 year

Secondary Outcomes (1)

  • Microbiome composition

    1 month

Study Arms (3)

No intervention

NO INTERVENTION

No intervention after antibiotic treatment.

Probiotic microbiome rehabilitation

ACTIVE COMPARATOR

Probiotic treatment after antibiotic treatment.

Dietary Supplement: Probiotic treatment

Bacteriotherapy microbiome rehabilitation

ACTIVE COMPARATOR

Bacteriotherapy after antibiotic treatment.

Biological: Bacteriotherapy

Interventions

Probiotic treatmentDIETARY_SUPPLEMENT

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

Probiotic microbiome rehabilitation
BacteriotherapyBIOLOGICAL

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

Bacteriotherapy microbiome rehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroentherology

Tel Aviv, 64239, Israel

RECRUITING

Study Officials

  • Zamir Halpern, MD

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Noya Horowitz, PhD

CONTACT

97236974297noyah@tlvmc.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2017

First Posted

July 14, 2017

Study Start

February 1, 2013

Primary Completion

December 30, 2019

Study Completion

December 30, 2020

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations

IL(1)