microbiome: Endoscopic Assessment and Prediction of Microbiome-modifying Interventions

• Sponsor: Tel-Aviv Sourasky Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03218579
• Collaborator: Weizmann Institute of Science (Other)
• Enrollment: 45
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 94.9
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gut Microbiome; Antibiotic Side Effect	Dietary Supplement: Probiotic treatment; Biological: Bacteriotherapy	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 45 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Endoscopic Assessment and Prediction of Microbiome-modifying Interventions
• Actual Study Start Date: Feb 1, 2013
• Anticipated Primary Completion Date: Dec 30, 2019
• Anticipated Study Completion Date: Dec 30, 2020

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Microbiome composition [1 year]

   stool samples

Secondary Outcome Measures

1. Microbiome composition [1 month]

   Gastrointestinal tract biopsies

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Gastroentherology	Tel Aviv		Israel	64239

Sponsors and Collaborators

• Tel-Aviv Sourasky Medical Center
• Weizmann Institute of Science

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tel-Aviv Sourasky Medical Center
• ClinicalTrials.gov Identifier: NCT03218579
• Other Study ID Numbers: TASMC-12-ZH-658-CTIL
• First Posted: Jul 14, 2017
• Last Update Posted: Jul 21, 2017
• Last Verified: Jul 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Tel-Aviv Sourasky Medical Center: microbiome; intestinal bacteria

Study Results

No Results Posted as of Jul 21, 2017