Fecal AnalysisPhase 4LGG BB-12NCT01757054
Fecal Recovery of the Probiotic Bacteria Lactobacillus Rhamnosus GG (LGG) and Bifidobacterium Animalis Subspecies Lactis BB-12 (BB-12) in Healthy Humans Following Daily Consumption of a Probiotic Supplement
A Phase 4 study testing ProNutrients Probiotic in people with Fecal Analysis, run by Pfizer at 1 site in United States.
Trial summary
The main hypothesis of this study is that there will be a significant increase of Lactobacillus rhamnosus GG (LGG) and Bifidobacterium lactis (BB-12) in the stool of healthy humans following daily consumption of a probiotic supplement containing these specific strains of probiotic bacteria. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Fecal Analysis
- What is being tested?
- ProNutrients Probiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Oct 2013
- Phase
- Phase 4
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are between 18-70 years of age. Have regular bowel movements. Are willing and able to attend study visits, undergo limited blood and urine testing, take the nutritional supplement according to the instructions provided.
- Are willing to collect four stool specimens and bring them to the study site.
Who cannot join
- Are unwilling to follow the dietary guidelines of the study. Are lactose-intolerant or have allergies to milk or wheat. Have had drug or alcohol problems within the previous year. Are or plan to become pregnant over the next 3 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
Boston, Massachusetts, 02111
About this study
Official title: Randomized, Two Arm, Parallel Group, Open Label, Single Center Prospective Study of the Fecal Recovery of Lactobacillus Rhamnosus GG (LGG) and Bifidobacterium Animalis Subspecies Lactis (BB-12) in Healthy Humans Following Daily Consumption of ProNutrients Probiotic Powder Sachet
The main hypothesis of this study is that there will be a significant increase of Lactobacillus rhamnosus GG (LGG) and Bifidobacterium lactis (BB-12) in the stool of healthy humans following daily consumption of a probiotic supplement containing these specific strains of probiotic bacteria.
Read the detailed description
To demonstrate recovery of live probiotic bacteria in the stool.
- Conditions
- Fecal Analysis
- Being tested
- ProNutrients Probiotic
- Keywords
- probiotic, LGG, BB-12, fecal recovery, healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProNutrients ProbioticDietary supplement
Dosage is 1 individually wrapped packet (1 gram) containing probiotic powder per day for 21 days
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | Not described Receives: Dietary Supplement: ProNutrients Probiotic |
| Control group | No intervention | This is a non-supplemented control group that will follow the same dietary and medication restrictions. The purpose of this group is to ensure results are due to supplementation and not due to random dietary exposure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fecal concentration of both LGG and BB-12 by quantitative culture with confirmatory PCR at baseline and 3 weeks
Pre- to post-supplementation changes in fecal concentration of both LGG and BB-12 by quantitative culture with confirmatory PCR
Measured: Baseline, 3 weeks
Secondary outcomes (6)
Change in fecal concentration of both LGG and BB-12 by quantitative culture with confirmatory PCR at baseline and 2 weeks
Pre- to post-supplementation changes in fecal concentration of both LGG and BB-12 by quantitative culture with confirmatory PCR
Measured: Baseline, 2 weeks
Change in fecal concentration of both LGG and BB-12 by quantitative PCR (qPCR) at baseline and 3 weeks
Pre- to post-supplementation changes in fecal concentration of both LGG and BB-12 by quantitative PCR (qPCR)
Measured: Baseline, 3 weeks
Change in fecal concentration of both LGG and BB-12 by quantitative PCR (qPCR) at baseline and 2 weeks
Pre- to post-supplementation changes in fecal concentration of both LGG and BB-12 by quantitative PCR (qPCR)
Measured: Baseline, 2 weeks
Change in fecal concentration of both LGG and BB-12 by quantitative culture with confirmatory PCR and qPCR in probiotic compared to control group at baseline and 3 weeks
Pre- to post-supplementation changes in fecal concentration of both LGG and BB-12 by quantitative culture with confirmatory PCR and qPCR in probiotic compared to control group
Measured: Baseline, 3 weeks
Change in fecal concentration of both LGG and BB-12 by quantitative culture with confirmatory PCR and qPCR in probiotic compared to control group at baseline and 2 weeks
Pre- to post-supplementation changes in fecal concentration of both LGG and BB-12 by quantitative culture with confirmatory PCR and qPCR in probiotic compared to control group
Measured: Baseline, 2 weeks
Change in fecal concentration of LGG and BB-12 by both quantitative culture with confirmatory PCR and qPCR at baseline, 3 weeks, and 28 days post supplementation
Post-supplementation fecal concentration of LGG and BB-12 by both quantitative culture with confirmatory PCR and qPCR compared to baseline and 3 week supplementation values
Measured: Baseline, 3 weeks, 28 days follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2012 (estimated)
- Study startFeb 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal AnalysisStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757054
- Sponsor's protocol ID
- B4141001
- Other IDs
- PO-10-08
- Acronym
- LGG BB-12
- Status last verified
- Oct 2013
- First submitted
- 20 Dec 2012
- Last updated
- 30 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Two Arm, Parallel Group, Open Label, Single Center Prospective Study of the Fecal Recovery of Lactobacillus Rhamnosus GG (LGG) and Bifidobacterium Animalis Subspecies Lactis (BB-12) in Healthy Humans Following Daily Consumption of ProNutrients Probiotic Powder Sachet
- ClinicalTrials.gov ID
- NCT01757054
- Acronym / sponsor ID
- LGG BB-12 / B4141001
- Conditions
- Fecal Analysis
- Keywords
- probiotic, LGG, BB-12, fecal recovery, healthy subjects
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 28 Dec 2012 (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 main hypothesis of this study is that there will be a significant increase of Lactobacillus rhamnosus GG (LGG) and Bifidobacterium lactis (BB-12) in the stool of healthy humans following daily consumption of a probiotic supplement containing these specific strains of probiotic bacteria.
Detailed description
To demonstrate recovery of live probiotic bacteria in the stool.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Dietary Supplement: ProNutrients Probiotic |
| Control group | No intervention | –This is a non-supplemented control group that will follow the same dietary and medication restrictions. The purpose of this group is to ensure results are due to supplementation and not due to random dietary exposure. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Are between 18-70 years of age. Have regular bowel movements. Are willing and able to attend study visits, undergo limited blood and urine testing, take the nutritional supplement according to the instructions provided.
- Are willing to collect four stool specimens and bring them to the study site.
Key exclusion criteria (1 listed)
- Are unwilling to follow the dietary guidelines of the study. Are lactose-intolerant or have allergies to milk or wheat. Have had drug or alcohol problems within the previous year. Are or plan to become pregnant over the next 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 |
|---|---|---|
| ProNutrients ProbioticDosage is 1 individually wrapped packet (1 gram) containing probiotic powder per day for 21 days | Dietary supplement | Probiotic group |
Primary outcome
Change in fecal concentration of both LGG and BB-12 by quantitative culture with confirmatory PCR at baseline and 3 weeks
Time frame: Baseline, 3 weeks
Pre- to post-supplementation changes in fecal concentration of both LGG and BB-12 by quantitative culture with confirmatory PCR
6 secondary outcomes
Change in fecal concentration of both LGG and BB-12 by quantitative culture with confirmatory PCR at baseline and 2 weeks
Time frame: Baseline, 2 weeks
Change in fecal concentration of both LGG and BB-12 by quantitative PCR (qPCR) at baseline and 3 weeks
Time frame: Baseline, 3 weeks
Change in fecal concentration of both LGG and BB-12 by quantitative PCR (qPCR) at baseline and 2 weeks
Time frame: Baseline, 2 weeks
Change in fecal concentration of both LGG and BB-12 by quantitative culture with confirmatory PCR and qPCR in probiotic compared to control group at baseline and 3 weeks
Time frame: Baseline, 3 weeks
Change in fecal concentration of both LGG and BB-12 by quantitative culture with confirmatory PCR and qPCR in probiotic compared to control group at baseline and 2 weeks
Time frame: Baseline, 2 weeks
Change in fecal concentration of LGG and BB-12 by both quantitative culture with confirmatory PCR and qPCR at baseline, 3 weeks, and 28 days post supplementation
Time frame: Baseline, 3 weeks, 28 days follow up
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 30 Oct 2013.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ProNutrients Probiotic in people with Fecal Analysis, run by Pfizer 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 2 inclusion and 1 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 30 Oct 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change in fecal concentration of both LGG and BB-12 by quantitative culture with confirmatory PCR at baseline and 3 weeks (time frame: Baseline, 3 weeks). 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 30 Oct 2013.