HealthyPhase 1NCT00934453
Safety of Lactobacillus Rhamnosus GG ATCC 53103 (LGG) in Healthy Volunteers
A Phase 1 study testing Lactobacillus rhamnosus GG ATCC 53103 in people with Healthy, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
This study is a single site, Phase I, masked, randomized study to evaluate the safety and tolerability of twice daily dosing of LGG (Lactobacillus GG ATCC 53103) in normal healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lactobacillus rhamnosus GG ATCC 53103
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2009to May 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-50 years, inclusive.
- Expressed interest and ability to fulfill the study requirements.
- Be in general good health as determined by a screening evaluation within 30 days of the first dose of LGG or placebo.
- Able to ingest the study drug (LGG or placebo) dissolved in a small amount of cow's milk or soy milk orally (no feeding tube).
- Willing to prevent pregnancy - Women must agree not to become pregnant or breastfeed from the time of study enrollment until at least 3 months after the last dose of study drug. If a woman is sexually active and has no history of hysterectomy or tubal ligation, she must agree to practice an acceptable method of birth control, such as hormonal or barrier birth control. A woman is eligible if she is monogamous with a vasectomized male. Sexually active male volunteers without vasectomy must agree to use a barrier method of contraception for 3 months after the last dose of study drug.
- Willing to comply with protocol and report on compliance and side effects during study period.
- Informed consent obtained and signed prior to screening.
Who cannot join
- Consumption of supplements or food products containing LGG or probiotics 30 days prior to the start of the study or consumption of yogurt that has "live and active cultures" seal.
- Known or suspected allergies to probiotics, Lactobacillus, microcrystalline cellulose, gelatin, or any antibiotic that may be used to treat LGG bacteremia or infection (Ampicillin, Clindamycin, Moxifloxacin).
- Received oral or parenteral antibiotics within 4 weeks of enrollment or prescribed antibiotics on day of enrollment.
- Drug or alcohol abuse within previous 12 months.
- Major surgery or endoscopy within last 3 months.
- Daily prescription or over-the-counter medicines except for vitamins, birth control products, and hormone replacement therapy.
Show all 31Show fewer
- Presence of any of the following:
- Abnormal vital signs or clinically significant physical findings such as murmur (other than functional), hepatosplenomegaly, jaundice, lymphadenopathy, or focal neurological deficit
- Indwelling catheter or implanted hardware/prosthetic device or feeding tube
- Febrile illness (oral temperature >37 degrees Celsius) or one or more episodes of diarrhea within 72 hours of baseline visit (first dose of study drug)
- Active bowel leak, acute abdomen, colitis, or active GI disease or history of gastric or intestinal dysmotility, slowed transit time, variable small intestinal permeability, pancreatitis, or inflammatory bowel disease
- History of Hepatitis B or Hepatitis C infections, cirrhosis, or chronic liver disease
- Underlying structural heart disease or previous history of endocarditis or valve replacement
- Immunosuppression including HIV positive, solid organ or stem cell transplant recipient, receiving any oral or parenteral immunosuppressive therapy, neutrophil count <500/mm^3, or an anticipated drop in the neutrophil count to <500/mm3
- History of cancer
- History of collagen vascular disease
- Active TB
- Women only - pregnant, planning on becoming pregnant within the next 9 months, breastfeeding, positive urine pregnancy test during screening or within 24 hours of first dose of study drug, or unwilling to undergo pregnancy testing.
- Positive drug or alcohol testing at screening or within 24 hours of first dose of study drug, or unwilling to undergo drug and alcohol testing.
- Screening laboratory tests greater than upper normal limit (ULN) or less than lower normal limit (LLN):
- White blood cell <LLN or >ULN
- Platelets <LLN
- Hemoglobin <LLN
- Creatinine >ULN
- Blood urea nitrogen >ULN
- Aspartate aminotransferase >ULN
- Alanine aminotransferase >ULN
- Alkaline phosphatase >ULN
- Bilirubin >ULN
- Glucose (nonfasting ) >109 mg/dL
- Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer participating in the study or would make it unlikely the volunteer could complete the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02111
Tufts Medical Center
Boston, Massachusetts, 02111
About this study
Official title: A Phase I, Randomized Study to Evaluate the Safety of Lactobacillus Rhamnosus GG ATCC 53103 (LGG) in Healthy Volunteers
This study is a single site, Phase I, masked, randomized study to evaluate the safety and tolerability of twice daily dosing of LGG (Lactobacillus GG ATCC 53103) in normal healthy adult volunteers. Study drug capsules (1x10^10 LGG/capsule or placebo) will be taken by mouth twice a day with cow's milk or soy milk on an outpatient basis. Volunteers will have study visits at baseline, 1 month, 3 months, 6 months, 7 months, and 12 months where they will be asked about any medical problems that have come up since the last study visit, have vital signs taken, review current medication use, and review any signs of potential adverse events. Blood and urine samples will also be collected at these visits, as well as throat and stool samples.
Our goal is to assess the safety and tolerability of LGG when administered to healthy adult volunteers twice a day. Assessment of safety will be determined by vital sign measurements, physical examinations, clinical laboratory tests, and from the incidence and severity of adverse events that occur during study participation. Additionally, we will assess whether LGG colonizes the throat and/or gastrointestinal tract of healthy adult volunteers and assess the effect of LGG on the bacteria that normally live in the throat and GI tract by using culture-independent techniques. Volunteers enrolled in this study will also be invited to participate in a companion genetic study that will investigate the host immune response to the bacteria in LGG.
- Conditions
- Healthy
- Being tested
- Lactobacillus rhamnosus GG ATCC 53103, Placebo
- Keywords
- Healthy adult volunteers, Lactobacillus rhamnosus GG, probiotic, dietary supplement, safety, Safety Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus rhamnosus GG ATCC 53103Biological
Also called Culturelle, LGG
Study drug capsules (1x10^10 LGG/capsule) are to be taken orally twice a day every day dissolved in cow's milk or soy milk on an outpatient basis for six months.
PlaceboBiological
Placebo capsules composed of microcrystalline cellulose are to be taken orally twice a day dissolved in cow's milk or soy milk on an outpatient basis for six months.
| Study group | Role | What they receive |
|---|---|---|
| LGG | Experimental | Lactobacillus rhamnosus GG (LGG) capsules containing 1x10^10 LGG per capsule will be given to volunteers with verbal and written instructions at the baseline visit. Capsules are to be taken orally twice a day dissolved in cow's milk or soy milk on an outpatient basis. Receives: Biological: Lactobacillus rhamnosus GG ATCC 53103 |
| Placebo | Placebo comparator | Placebo capsules composed of microcrystalline cellulose are to be taken orally twice a day dissolved in cow's milk or soy milk on an outpatient basis. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital signs, including weight, temperature, resting blood pressure, heart rate, and respiratory rate, will be taken. The rate of notable vital sign abnormalities and changes from baseline to each post-baseline visit will be summarized by group.
Measured: Baseline, 1 month, 3 months, 6 months, 7 months, 12 months
Physical examination will be performed. The abnormal findings in physical examination will be summarized by treatment group using descriptive statistics.
Measured: Baseline, 1 month, 3 months, 6 months, 7 months, 12 months
Clinical laboratory tests - abnormal values, clinically significant abnormal range, overall lab data, and changes from baseline will be summarized by cohort.
Measured: Baseline, 1 month, 3 months, 6 months, 7 months, 12 months
Adverse event assessment
Measured: Baseline, day 3, day 7, day 14, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 12 months
Secondary outcomes (4)
Throat samples will be obtained for routine culture including quantitative analyses of LGG and also for extraction of bacterial DNA to describe the microbiota (bacteria normally present) of the oropharynx.
Measured: Baseline, month 1, month 3, month 6, month 7, month 12
Stool samples will be obtained for routine culture including quantitative analyses of LGG and also for extraction of bacterial DNA to describe the microbiota (bacteria normally present) of the GI tract.
Measured: Baseline, month 1, month 3, month 6, month 7, month 12
Additional blood samples (approximately 1/2 teaspoon per study visit) will be collected to determine the expression of immune associated markers in the blood if volunteers participate in the companion genetic study.
Measured: Baseline, month 1, month 3, month 6, month 7 and month 12
Stool samples (already collected - see above) will also be evaluated for changes in intestinal microflora if volunteers participate in the companion genetic study.
Measured: Baseline, 1 month, 3 months, 6 months, 7 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startDec 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia L. Hibberd, Massachusetts General Hospital
- Investigators
- Patricia L. Hibberd, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934453
- Sponsor's protocol ID
- 8996
- Status last verified
- Jan 2017
- First submitted
- 7 Jul 2009
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized Study to Evaluate the Safety of Lactobacillus Rhamnosus GG ATCC 53103 (LGG) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00934453
- Acronym / sponsor ID
- 8996
- Conditions
- Healthy
- Keywords
- Healthy adult volunteers, Lactobacillus rhamnosus GG, probiotic, dietary supplement, safety, Safety Assessment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 8 Jul 2009 (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.
This study is a single site, Phase I, masked, randomized study to evaluate the safety and tolerability of twice daily dosing of LGG (Lactobacillus GG ATCC 53103) in normal healthy adult volunteers. Study drug capsules (1x10^10 LGG/capsule or placebo) will be taken by mouth twice a day with cow's milk or soy milk on an outpatient basis. Volunteers will have study visits at baseline, 1 month, 3 months, 6 months, 7 months, and 12 months where they will be asked about any medical problems that have come up since the last study visit, have vital signs taken, review current medication use, and review any signs of potential adverse events. Blood and urine samples will also be collected at these visits, as well as throat and stool samples.
Our goal is to assess the safety and tolerability of LGG when administered to healthy adult volunteers twice a day. Assessment of safety will be determined by vital sign measurements, physical examinations, clinical laboratory tests, and from the incidence and severity of adverse events that occur during study participation. Additionally, we will assess whether LGG colonizes the throat and/or gastrointestinal tract of healthy adult volunteers and assess the effect of LGG on the bacteria that normally live in the throat and GI tract by using culture-independent techniques. Volunteers enrolled in this study will also be invited to participate in a companion genetic study that will investigate the host immune response to the bacteria in LGG.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LGG | Experimental | Biological: Lactobacillus rhamnosus GG ATCC 53103Lactobacillus rhamnosus GG (LGG) capsules containing 1x10^10 LGG per capsule will be given to volunteers with verbal and written instructions at the baseline visit. Capsules are to be taken orally twice a day dissolved in cow's milk or soy milk on an outpatient basis. |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo capsules composed of microcrystalline cellulose are to be taken orally twice a day dissolved in cow's milk or soy milk on an outpatient basis. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18-50 years, inclusive.
- Expressed interest and ability to fulfill the study requirements.
- Be in general good health as determined by a screening evaluation within 30 days of the first dose of LGG or placebo.
- Able to ingest the study drug (LGG or placebo) dissolved in a small amount of cow's milk or soy milk orally (no feeding tube).
- Willing to prevent pregnancy - Women must agree not to become pregnant or breastfeed from the time of study enrollment until at least 3 months after the last dose of study drug. If a woman is sexually active and has no history of hysterectomy or tubal ligation, she must agree to practice an acceptable method of birth control, such as hormonal or barrier birth control. A woman is eligible if she is monogamous with a vasectomized male. Sexually active male volunteers without vasectomy must agree to use a barrier method of contraception for 3 months after the last dose of study drug.
Key exclusion criteria (31 listed)
- Consumption of supplements or food products containing LGG or probiotics 30 days prior to the start of the study or consumption of yogurt that has "live and active cultures" seal.
- Known or suspected allergies to probiotics, Lactobacillus, microcrystalline cellulose, gelatin, or any antibiotic that may be used to treat LGG bacteremia or infection (Ampicillin, Clindamycin, Moxifloxacin).
- Received oral or parenteral antibiotics within 4 weeks of enrollment or prescribed antibiotics on day of enrollment.
- Drug or alcohol abuse within previous 12 months.
- Major surgery or endoscopy within last 3 months.
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 rhamnosus GG ATCC 53103Also: Culturelle, LGGStudy drug capsules (1x10^10 LGG/capsule) are to be taken orally twice a day every day dissolved in cow's milk or soy milk on an outpatient basis for six months. | Biological | LGG |
| PlaceboPlacebo capsules composed of microcrystalline cellulose are to be taken orally twice a day dissolved in cow's milk or soy milk on an outpatient basis for six months. | Biological | Placebo |
Primary outcome
Vital signs, including weight, temperature, resting blood pressure, heart rate, and respiratory rate, will be taken. The rate of notable vital sign abnormalities and changes from baseline to each post-baseline visit will be summarized by group.
Time frame: Baseline, 1 month, 3 months, 6 months, 7 months, 12 months
Physical examination will be performed. The abnormal findings in physical examination will be summarized by treatment group using descriptive statistics.
Time frame: Baseline, 1 month, 3 months, 6 months, 7 months, 12 months
Clinical laboratory tests - abnormal values, clinically significant abnormal range, overall lab data, and changes from baseline will be summarized by cohort.
Time frame: Baseline, 1 month, 3 months, 6 months, 7 months, 12 months
Adverse event assessment
Time frame: Baseline, day 3, day 7, day 14, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 12 months
4 secondary outcomes
Throat samples will be obtained for routine culture including quantitative analyses of LGG and also for extraction of bacterial DNA to describe the microbiota (bacteria normally present) of the oropharynx.
Time frame: Baseline, month 1, month 3, month 6, month 7, month 12
Stool samples will be obtained for routine culture including quantitative analyses of LGG and also for extraction of bacterial DNA to describe the microbiota (bacteria normally present) of the GI tract.
Time frame: Baseline, month 1, month 3, month 6, month 7, month 12
Additional blood samples (approximately 1/2 teaspoon per study visit) will be collected to determine the expression of immune associated markers in the blood if volunteers participate in the companion genetic study.
Time frame: Baseline, month 1, month 3, month 6, month 7 and month 12
Stool samples (already collected - see above) will also be evaluated for changes in intestinal microflora if volunteers participate in the companion genetic study.
Time frame: Baseline, 1 month, 3 months, 6 months, 7 months, and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Patricia L. Hibberd, MD, PhD principal investigator
Massachusetts General Hospital
2 sites 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 rhamnosus GG ATCC 53103 in people with Healthy, run by Massachusetts General Hospital at 2 sites 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 31 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 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Vital signs, including weight, temperature, resting blood pressure, heart rate, and respiratory rate, will be taken. The rate of notable vital sign abnormalities and changes from baseline to each post-baseline visit will be summarized by group. (time frame: Baseline, 1 month, 3 months, 6 months, 7 months, 12 months). The study lists 4 primary outcomes in all. 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 11 Jan 2017.