Vancomycin Resistant Enterococcal ColonizationPhase 1VRENCT00756262
Probiotic Lactobacillus GG to Eliminate VRE Colonization
A Phase 1 study testing Lactobacillus GG or Culturelle in people with Vancomycin Resistant Enterococcal Colonization, run by Tufts Medical Center at 1 site in United States.
Trial summary
The use of LGG will be associated with elimination of VRE colonization. The primary comparison will be VRE elimination rates among those patients that receive LGG compared to those that receive placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vancomycin Resistant Enterococcal Colonization
- What is being tested?
- Lactobacillus GG or Culturelle
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Jul 2012
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years
- Identified as having had a clinical isolate or stool or rectal swab culture positive for VRE
- Able to give informed consent and report on side effects
- Tolerating an oral/enteral diet
- Stable comorbid conditions
- Willing and able to come to Tufts for weekly visits
- Outpatient
Who cannot join
- Inpatients
- Active infection with VRE being treated
- Pregnancy
- Known use of LGG or another probiotic (not including yogurt) within the previous 30 days
- Presence of an active bowel leak, acute abdomen, active intestinal disease, or significant bowel dysfunction
- Presence of an absolute neutrophil count less than 500 per cubic mm or anticipation post chemotherapy that the absolute neutrophil count will fall below 500 per cubic mm
Show all 19Show fewer
- History of adverse reaction to product containing lactobacillus
- Active colitis (see definition below)
- Treatment with an antibiotic with activity against VRE
- Life expectancy less than one year or life-threatening condition
- Known or suspected allergies to probiotics, lactobacillus, milk protein, and microcrystalline cellulose
- Structural heart disease, history of endocarditis or valve replacement
- Positive baseline stool culture for LGG
- Recent or planned chemotherapy or radiation therapy
- Solid organ transplant within the prior year
- Stem cell transplant within the prior year
- On active immunosuppressive medication [anti-rejection, injectable immunosuppressive drugs for autoimmune disease, or corticosteroids (greater than 1/2 mg per kg body weight of prednisone or its equivalent) not including inhaled or topical steroids]
- Allergy or intolerance to or contraindication to two or more of the rescue antibiotic regimens (ampicillin, clindamycin, moxifloxacin)
- Colitis will be defined as a history of Crohn's disease or ulcerative colitis with active diarrhea, active diarrhea due to Clostridium difficile infection, active diarrhea due to known or unknown cause with a stool specimen showing fecal leukocytes (if none has been done in such a patient this will be requested prior to enrollment). Diarrhea will be defined as more than three unformed bowel movements per day. The subject's primary physician will be asked to assess the subject's life expectancy, and subjects with an estimated life expectancy of less than one year as judged by the physician who knows him or her best will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts Medical Center-Division of Geographic Medicine and Infectious Diseases
Boston, Massachusetts, 02111
About this study
The use of LGG will be associated with elimination of VRE colonization.
The primary comparison will be VRE elimination rates among those patients that receive LGG compared to those that receive placebo. The primary endpoint will be the proportion of patients with VRE at one week after cessation of administration of study medication or placebo. The investigators assume that the placebo group will have very little spontaneous elimination of VRE and that the LGG group will be more likely to have eliminated VRE colonization at the end of one week.
- Being tested
- Lactobacillus GG or Culturelle
- Keywords
- Vancomycin Resistant enterococcal colonization, Probiotics, LGG, Lactobacillus rhamnosus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus GG or CulturelleBiological
Also called Lactobacillus GG (LGG), Placebo is microcrystalline cellulose
Drug to be administered orally (capsule form). Dose=2 capsules/day for 14 days. Dosage strength= 1x10^10 bacteria
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Lactobacillus rhamnosus LGG Receives: Biological: Lactobacillus GG or Culturelle |
| 2 | Placebo comparator | Microcrystalline cellulose capsules Receives: Biological: Lactobacillus GG or Culturelle |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be the proportion of patients with VRE at one week after cessation of administration of study medication or placebo.
Measured: Day 21post enrollment
Secondary outcomes (4)
The rate of VRE colonization in LGG recipients versus controls at 2 weeks and 6 weeks post discontinuation of administration of LGG or placebo.
Measured: 2 weeks, and 6 weeks
The rate of LGG colonization in study population receiving LGG compared to placebo.
Measured: days 21, 28, 56
That LGG can be used safely and without significant side effects in both hospitalized and ambulatory patients.
Measured: day 0-56 and 6 mnths
That among those treated with LGG, the colony counts of VRE will be lower when compared to controls even among those in whom colonization is not eliminated.
Measured: day 0,7,14,21,28,56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study startMar 2003
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: Insufficient recruitment, no additional funding available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vancomycin Resistant Enterococcal ColonizationStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756262
- Sponsor's protocol ID
- 6283
- Other IDs
- 5 R 21 AT-001892
- Acronym
- VRE
- Status last verified
- Jan 2024
- First submitted
- 19 Sep 2008
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Doron S, Hibberd PL, Goldin B, Thorpe C, McDermott L, Snydman DR. Effect of Lactobacillus rhamnosus GG Administration on Vancomycin-Resistant Enterococcus Colonization in Adults with Comorbidities. Antimicrob Agents Chemother. 2015 Aug;59(8):4593-9. doi: 10.1128/AAC.00300-15. Epub 2015 May 26.
PubMed 26014940
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotic Lactobacillus GG to Eliminate VRE Colonization
- ClinicalTrials.gov ID
- NCT00756262
- Acronym / sponsor ID
- VRE / 6283
- Keywords
- Vancomycin Resistant enterococcal colonization, Probiotics, LGG, Lactobacillus rhamnosus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment, no additional funding available
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- Mar 2003
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 22 Sep 2008 (estimated)
- 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 use of LGG will be associated with elimination of VRE colonization.
The primary comparison will be VRE elimination rates among those patients that receive LGG compared to those that receive placebo. The primary endpoint will be the proportion of patients with VRE at one week after cessation of administration of study medication or placebo. The investigators assume that the placebo group will have very little spontaneous elimination of VRE and that the LGG group will be more likely to have eliminated VRE colonization at the end of one week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: Lactobacillus GG or CulturelleLactobacillus rhamnosus LGG |
| 2 | Placebo comparator | Biological: Lactobacillus GG or CulturelleMicrocrystalline cellulose capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age greater than or equal to 18 years
- Identified as having had a clinical isolate or stool or rectal swab culture positive for VRE
- Able to give informed consent and report on side effects
- Tolerating an oral/enteral diet
- Stable comorbid conditions
Key exclusion criteria (19 listed)
- Inpatients
- Active infection with VRE being treated
- Pregnancy
- Known use of LGG or another probiotic (not including yogurt) within the previous 30 days
- Presence of an active bowel leak, acute abdomen, active intestinal disease, or significant bowel dysfunction
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 |
|---|---|---|
| Lactobacillus GG or CulturelleAlso: Lactobacillus GG (LGG), Placebo is microcrystalline celluloseDrug to be administered orally (capsule form). Dose=2 capsules/day for 14 days. Dosage strength= 1x10^10 bacteria | Biological | 1, 2 |
Primary outcome
The primary endpoint will be the proportion of patients with VRE at one week after cessation of administration of study medication or placebo.
Time frame: Day 21post enrollment
4 secondary outcomes
The rate of VRE colonization in LGG recipients versus controls at 2 weeks and 6 weeks post discontinuation of administration of LGG or placebo.
Time frame: 2 weeks, and 6 weeks
The rate of LGG colonization in study population receiving LGG compared to placebo.
Time frame: days 21, 28, 56
That LGG can be used safely and without significant side effects in both hospitalized and ambulatory patients.
Time frame: day 0-56 and 6 mnths
That among those treated with LGG, the colony counts of VRE will be lower when compared to controls even among those in whom colonization is not eliminated.
Time frame: day 0,7,14,21,28,56
Results and safety
The study was stopped early (reason given: Insufficient recruitment, no additional funding available). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Results publication: PubMed 26014940Doron S, Hibberd PL, Goldin B, Thorpe C, McDermott L, Snydman DR. Effect of Lactobacillus rhamnosus GG Administration on Vancomycin-Resistant Enterococcus Colonization in Adults with Comorbidities. Antimicrob Agents Chemother. 2015 Aug;59(8):4593-9. doi: 10.1128/AAC.00300-15. Epub 2015 May 26.
Related trials for Vancomycin Resistant Enterococcal Colonization
RecruitingPhase 2
Further MT for Antibiotic-Resistant Bacterial Colonization
Intestinal Multi-drug Resistant Organism Colonization
Enrolling by invitation
Human Clinical Trial to Evaluate the Decolonization Efficacy of BM111 Against Carbapenem-Resistant Enterobacteriaceae (CRE) and Vancomycin-Resistant Enterococcus (VRE)
VRE Colonization, CRE Colonization
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lactobacillus GG or Culturelle in people with Vancomycin Resistant Enterococcal Colonization, run by Tufts 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 7 inclusion and 19 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: stopped early, as of the sponsor's last update on 5 Jan 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient recruitment, no additional funding available). Results are not available in the source record.
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?
The primary endpoint will be the proportion of patients with VRE at one week after cessation of administration of study medication or placebo. (time frame: Day 21post enrollment). 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 NCT00756262, which also lists 1 linked publication.
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 5 Jan 2024.