Gut MicrobiomemicrobiomeNCT03218579
Endoscopic Assessment and Prediction of Microbiome-modifying Interventions
A study testing Probiotic treatment and Bacteriotherapy in people with Gut Microbiome and Antibiotic Side Effect, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiome, Antibiotic Side Effect
- What is being tested?
- Probiotic treatment and Bacteriotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Feb 2013to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Age: 18 years and up
- Gender: women and men
Who cannot join
- Pregnancy
- Age under 18 years
- antibiotic treatment 3 months prior to enrollment
- Viral Hepatitis
- HIV positive
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Department of Gastroentherology
Tel Aviv, 64239
Zamir Halpern, MD, 6974282, halpernza@tlvmc.gov.il
Zamir Halpern, MD
About this study
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.
Read the 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
- Gut Microbiome, Antibiotic Side Effect
- Being tested
- Probiotic treatment, Bacteriotherapy
- Keywords
- microbiome, intestinal bacteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic treatmentDietary supplement
4 weeks of probiotic treatment after 7 days of antibiotics (Metronidazole+Ciprofloxacin)
BacteriotherapyBiological
Bacteriotherapy (autologous fecal microbiota transplantation) after 7 days of antibiotics (Metronidazole+Ciprofloxacin)
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | No intervention after antibiotic treatment. |
| Probiotic microbiome rehabilitation | Active comparator | Probiotic treatment after antibiotic treatment. Receives: Dietary Supplement: Probiotic treatment |
| Bacteriotherapy microbiome rehabilitation | Active comparator | Bacteriotherapy after antibiotic treatment. Receives: Biological: Bacteriotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome composition
stool samples
Measured: 1 year
Secondary outcomes (1)
Microbiome composition
Gastrointestinal tract biopsies
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start1 Feb 2013
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiomeStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Weizmann Institute of Science
- Responsible party
- Sponsor
- Investigators
- Zamir Halpern, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218579
- Sponsor's protocol ID
- TASMC-12-ZH-658-CTIL
- Acronym
- microbiome
- Status last verified
- Jul 2017
- First submitted
- 13 Jul 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Assessment and Prediction of Microbiome-modifying Interventions
- ClinicalTrials.gov ID
- NCT03218579
- Acronym / sponsor ID
- microbiome / TASMC-12-ZH-658-CTIL
- Conditions
- Gut Microbiome, Antibiotic Side Effect
- Keywords
- microbiome, intestinal bacteria
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Weizmann Institute of Science
- Study start
- 1 Feb 2013 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 14 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | –No intervention after antibiotic treatment. |
| Probiotic microbiome rehabilitation | Active comparator | Dietary Supplement: Probiotic treatmentProbiotic treatment after antibiotic treatment. |
| Bacteriotherapy microbiome rehabilitation | Active comparator | Biological: BacteriotherapyBacteriotherapy after antibiotic treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy volunteers
- Age: 18 years and up
- Gender: women and men
Key exclusion criteria (5 listed)
- Pregnancy
- Age under 18 years
- antibiotic treatment 3 months prior to enrollment
- Viral Hepatitis
- HIV positive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic treatment4 weeks of probiotic treatment after 7 days of antibiotics (Metronidazole+Ciprofloxacin) | Dietary supplement | Probiotic microbiome rehabilitation |
| BacteriotherapyBacteriotherapy (autologous fecal microbiota transplantation) after 7 days of antibiotics (Metronidazole+Ciprofloxacin) | Biological | Bacteriotherapy microbiome rehabilitation |
Primary outcome
Microbiome composition
Time frame: 1 year
stool samples
1 secondary outcome
Microbiome composition
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zamir Halpern, MD principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic treatment and Bacteriotherapy in people with Gut Microbiome and Antibiotic Side Effect, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noya Horowitz, PhD (97236974297, noyah@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome composition (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.