Human Gut MicrobiotaNCT01414010

Effects of Pre-, Pro- & Anti-biotics on Gut Microbiota

A study testing Trametes versicolor extract, Saccharomyces boulardii and Amoxicillin in people with Human Gut Microbiota, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 39 yearsHealthy volunteers can take part
Conditions the study is for: Human Gut Microbiota
What is being tested?: Trametes versicolor extract, Saccharomyces boulardii and Amoxicillin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteUnited States
Study dates: Aug 2011to Feb 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 39 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Age 18 to 39 years (male or female)
Good general health
Able to comply with study requirements and to provide informed consent
For women of childbearing potential
A negative urine pregnancy test immediately prior to starting the study treatment
Agreement to comply with approved methods of contraception during the period of active study treatment (not required during follow-up)

Who cannot join

Any diagnosed autoimmune disease
History of organ transplantation
Known chronic or recurrent systemic disorder associated with immunocompromise
A history of allergy or hypersensitivity to mushroom or mushroom extract, brewer's or baker's yeast or to penicillins or cephalosporins (including amoxicillin).
History of severe allergic reaction (requiring hospital admission and/or the administration of parenteral medication or associated with dyspnoea, wheezing, hypotension, loss of consciousness).
Systemic antibacterial therapy during the 3 months prior to study enrollment

Show all 12Show fewer

New prescription medications during the 4 weeks prior to study enrollment
Prescription or OTC medications or supplements that are known to alter gut function or microflora (i.e. acid antisecretory drugs, probiotics) during the 4 weeks prior to study enrollment
Active gastrointestinal or metabolic disease
Prior gastrointestinal surgery (apart from appendectomy or cholecystectomy)
History of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average or chronic or recurrent diarrhea with spontaneous bowel movements more often than 3 times daily
Any condition or personal circumstance that, in the opinion of the investigator, renders the subject unlikely or unable to comply with the full study protocol.

Trial locations and contacts

1 site in 1 country.

United States1 site

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: Effects of Mushroom Extract, S Boulardii and Amoxicillin on the Human Microbiome

The purpose of this study is to compare and contrast the effects of a prebiotic (Trametes Versicolor), a probiotic (Saccharomyces boulardii) and an antibiotic (amoxicillin) on the gut microbiota of healthy volunteers. It is expected that treatment will result in the rapid and reproducible alterations in fecal microbiota that will spontaneously reverse in the weeks after treatment is discontinued.

Conditions: Human Gut Microbiota
Being tested: Trametes versicolor extract, Saccharomyces boulardii, Amoxicillin
Keywords: healthy volunteers, gut microbiota, gut microbiome, prebiotic, probiotic, antibiotic, antibiotic-associated diarrhea, intestinal bacterial overgrowth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Trametes versicolor extractDietary supplement
Also called turkey tail
1,200 mg, 3 times daily on an empty stomach for 14 days
Saccharomyces boulardiiDietary supplement
250 mg, 3 times daily on an empty stomach for 14 days
AmoxicillinDrug
250 mg 3 times daily at least 1 hour before meals for 7 days

Study groups in NCT01414010
Study group	Role	What they receive
Prebiotic	Active comparator	Not described Receives: Dietary Supplement: Trametes versicolor extract
Probiotic	Active comparator	Not described Receives: Dietary Supplement: Saccharomyces boulardii
Antibiotic	Active comparator	Not described Receives: Drug: Amoxicillin
Control	No intervention	Control group, no intervention given.

What is being measured

The primary outcome is the main question the study is designed to answer.

Bacteria Prevalence in Stool
The most prevalent bacterial genera within the study population
Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Days 10 and 14 After Treatment: Average of Days 21, 28, and 56
Measured: Day 0 to 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2011Feb 2012

First posted11 Aug 2011 (estimated)
Study startAug 2011
Primary completionFeb 2012
Study completionFeb 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Human Gut MicrobiotaStudies of the same condition, open and under way.
More trials run by Beth Israel Deaconess 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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01414010
Sponsor's protocol ID: 2010P000319
Status last verified: Jun 2017
First submitted: 5 Aug 2011
Last updated: 24 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Human Gut Microbiota trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Mushroom Extract, S Boulardii and Amoxicillin on the Human Microbiome
ClinicalTrials.gov ID: NCT01414010
Acronym / sponsor ID: 2010P000319
Conditions: Human Gut Microbiota
Keywords: healthy volunteers, gut microbiota, gut microbiome, prebiotic, probiotic, antibiotic, antibiotic-associated diarrhea, intestinal bacterial overgrowth
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Beth Israel Deaconess Medical CenterUniversity, hospital or other
Collaborators: Hong Kong Association for Health Care, Integrated Chinese Medicine Holdings
Study start: Aug 2011
Primary completion: Feb 2012 (actual)
Study completion: Feb 2012 (actual)
First posted: 11 Aug 2011 (estimated)
Results: Posted 24 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Prebiotic	Active comparator	Dietary Supplement: Trametes versicolor extract
Probiotic	Active comparator	Dietary Supplement: Saccharomyces boulardii
Antibiotic	Active comparator	Drug: Amoxicillin
Control	No intervention	–Control group, no intervention given.

Who may qualify

Ages: 18 to 39 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Age 18 to 39 years (male or female)
Good general health
Able to comply with study requirements and to provide informed consent
For women of childbearing potential
A negative urine pregnancy test immediately prior to starting the study treatment

Key exclusion criteria (12 listed)

Any diagnosed autoimmune disease
History of organ transplantation
Known chronic or recurrent systemic disorder associated with immunocompromise
A history of allergy or hypersensitivity to mushroom or mushroom extract, brewer's or baker's yeast or to penicillins or cephalosporins (including amoxicillin).
History of severe allergic reaction (requiring hospital admission and/or the administration of parenteral medication or associated with dyspnoea, wheezing, hypotension, loss of consciousness).

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
Trametes versicolor extractAlso: turkey tail1,200 mg, 3 times daily on an empty stomach for 14 days	Dietary supplement	Prebiotic
Saccharomyces boulardii250 mg, 3 times daily on an empty stomach for 14 days	Dietary supplement	Probiotic
Amoxicillin250 mg 3 times daily at least 1 hour before meals for 7 days	Drug	Antibiotic

Primary outcome

Bacteria Prevalence in Stool
Time frame: Day 0 to 56
The most prevalent bacterial genera within the study population Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Days 10 and 14 After Treatment: Average of Days 21, 28, and 56

Results and safety

Results posted to the registry on 24 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Prebiotic	8	6
Probiotic	8	8
Antibiotic	8	8
Control	8	8

Primary outcome: Bacteria Prevalence in Stool

Time frame: Day 0 to 56. Mean (Standard Deviation). Unit: percentage of bacterial genera in stool

Measure	Amoxicillin - Before Treatment n = 8	Amoxicillin - During Treatment n = 8	Amoxicillin - After Treatment n = 8	Control n = 8	Trametes Versicolor Extract - Before Treatment n = 6	Trametes Versicolor Extract - During Treatment n = 6	Trametes Versicolor Extract - After Treatment n = 6	Saccharomyces Boulardii - Before Treatment n = 7	Saccharomyces Boulardii - During Treatment n = 7	Saccharomyces Boulardii - After Treatment n = 7
Faecalibacterium	22.3 (0)	20.9 (0)	18.0 (0)	25.5 (0)	12.7 (0)	22.6 (0)	12.6 (0)	19.3 (0)	25.2 (0)	21.2 (0)
Bacteroides	13.9 (0)	17.9 (0)	17.3 (0)	22.3 (0)	23.6 (0)	17.6 (0)	21.8 (0)	12.6 (0)	10.8 (0)	16.6 (0)
Roseburia	12.6 (0)	6.1 (0)	10.2 (0)	9.1 (0)	8.6 (0)	11.4 (0)	15.1 (0)	7.3 (0)	6.2 (0)	7.3 (0)
Clostridium	7.9 (0)	9.9 (0)	9.4 (0)	6.4 (0)	11.3 (0)	8.0 (0)	12.1 (0)	10.6 (0)	10.9 (0)	10.5 (0)
Oscillospira	10.4 (0)	6.3 (0)	7.2 (0)	5.8 (0)	7.1 (0)	7.0 (0)	7.8 (0)	2.0 (0)	2.1 (0)	2.2 (0)
Dialister	8.2 (0)	2.5 (0)	8.8 (0)	9.0 (0)	6.6 (0)	7.3 (0)	5.4 (0)	12.2 (0)	14.3 (0)	11.4 (0)
Ruminococcus	5.1 (0)	3.2 (0)	4.0 (0)	3.8 (0)	6.4 (0)	6.6 (0)	4.8 (0)	3.7 (0)	5.9 (0)	5.0 (0)
Coprococcus	3.1 (0)	1.8 (0)	4.0 (0)	1.8 (0)	2.8 (0)	1.8 (0)	1.8 (0)	1.9 (0)	2.2 (0)	2.9 (0)

Amoxicillin - Before Treatment vs Amoxicillin - During Treatment vs Amoxicillin - After Treatment: p <0.05, ANOVA

Population analysed: The investigators expanded their studies on the probiotic (Saccharomyces boulardii) to constitute a full, separate study. Reference: NCT01473368.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Prebiotic	0 of 8 (0%)	2 of 8 (25%)	Not reported
Probiotic	0 of 8 (0%)	0 of 8 (0%)	Not reported
Antibiotic	0 of 8 (0%)	2 of 8 (25%)	Not reported
Control	0 of 8 (0%)	0 of 8 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Human Gut Microbiota

Active, not recruitingObservational study
Guangzhou Preterm and Term Birth Cohort Study
Preterm Birth, Neurodevelopmental Disorders
Not yet recruiting
AdHuman - Impact of Food Additives in Humans
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Recruiting
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Not yet recruiting
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IBS (Irritable Bowel Syndrome)
Not yet recruiting
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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.

Ciaran P Kelly, MD principal investigator

Beth Israel Deaconess 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 Trametes versicolor extract, Saccharomyces boulardii and Amoxicillin in people with Human Gut Microbiota, run by Beth Israel Deaconess Medical Center at 1 site in United States.

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 6 inclusion and 12 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: finished, as of the sponsor's last update on 24 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 United States. 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?

Yes. Results are posted in the registry (first posted 24 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bacteria Prevalence in Stool (time frame: Day 0 to 56). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01414010.

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 24 Jul 2017.