Bacterium; AgentNCT01650753
Colonization and Persistence of Bifidobacterium Longum
A study testing Probiotic Powder in people with Bacterium; Agent, run by University of Nebraska Lincoln.
Trial summary
Healthy adults referred to as the absence of intestinal disorders, liver and kidney problems, lactose intolerance, and no use of ongoing medication for chronic diseases will be recruited. This research study will test the persistence of the probiotic (healthy bacterial) strain Bifidobacterium longum spp. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bacterium; Agent
- What is being tested?
- Probiotic Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Nov 2015
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to give written informed consent and willingness to participate in the study and comply with its procedures.
- Male or Female
- Aged 19 years of age and over.
- Be in generally good health as determined by the investigators. BMI of 18.5-29.9 kg/m2
- Free of any gastrointestinal disorders or complaints, as determined by the Bowel Disease Questionnaire (Talley et al., 1990), at visit 1.
- Not pregnant and not lactating.
- Be able to provide fecal samples for the duration of the 14 week study.
- Be willing to complete the Gastrointestinal Symptom Rating Scale (GSRS) once a week.
Who cannot join
- Less than 19 years of age.
- Underweighted or obese based on BMI.
- Antibiotic usage 3 months prior to study or during study.
- Significant acute or chronic existing illness [cardiovascular, gastrointestinal, immunological] or a condition which in the investigators judgment, contraindicates involvement in the study.
- Prior gastrointestinal surgery (apart from appendicectomy and hernia repair) or recent unexplained bleeding which, in the Investigator's judgment, contraindicates participation in the study.
- Having a condition or taking a medication, dietary supplement or food product (e.g. probiotic yogurt) that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results.
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- Individuals who, in the opinion of the investigator, are considered to be poor clinical attendees or unlikely for any reason to be able to comply with the trial.
- Patients receiving treatment involving experimental drugs.
- Pregnant or lactating.
- Participation in a recent experimental trial less than 30 days prior to this study.
- Have a malignant disease or any concomitant end-stage organ disease, which, in the Investigator's judgment, contraindicates participation in the study.
- Inability to provide fecal samples for the duration of the 14 week study.
- Inability to complete the weekly GSRS.se on antibiotics, suppressed immune systems
About this study
Official title: Quantitative Evaluation of the Colonization and Persistence of Bifidobacterium Longum Ssp Longum AH1206 in the Gastrointestinal Tract and Its Tolerance by Human Subjects
Healthy adults referred to as the absence of intestinal disorders, liver and kidney problems, lactose intolerance, and no use of ongoing medication for chronic diseases will be recruited. This research study will test the persistence of the probiotic (healthy bacterial) strain Bifidobacterium longum spp. longum in the human gastrointestinal tract after it is consumed, how it is tolerated, and its interactions with other micro-organisms already present in your gastrointestinal tract. The strain used is similar to bacteria used in probiotic yogurts, and the species Bifidobacterium is generally regarded as safe. The patient will be asked to will be consume a probiotic powder containing Bifidobacterium longum spp. longum strain AH1206 and a placebo in a random order, with neither the patient nor the investigators knowing the identity of the preparations given. Persistence or presence of the probiotic strain will be based on analysis of fecal (stool or bowel movement) samples provided.
Read the detailed description
The study will be performed as a 14 week randomized crossover trial with two treatments, one of which is the placebo. The randomization design will be provided by collaborators at Mead Johnson, and the study will be performed double blinded, such that no study staff will be informed about the nature of the product. Each treatment period will consist of a one week baseline period, in which one fecal sample will be collected. This will be followed by a two week feeding period in which the probiotic will be administered at a constant dose of 10^10 cells per day in 50 to 100 ml of either cold or room temperature tab water. At day 7 and 14 (last day of feeding), a fecal sample will be collected. The last sample during feeding will also serve as day 0 of Test of Persistence (TOP) period. Persistence of the probiotic strains will be tested during the TOP period at day 4, 8, 16, and 28 (4 weeks) for a total of 7 fecal samples. The subjects will then crossover to the other treatment and the above fecal sample collections will be repeated. Fecal samples will be provided by the subjects using disposable stool collection containers not longer than 2 hours after defecation. In the lab fecal samples will be stored undiluted (four aliquots) and as 1/10 dilutions in PBS buffer (four aliquots). The investigators will also prepare five tubes with 1 gram aliquots of each fecal sample and will provide these samples de-identified to Mead Johnson Nutrition for future analyses. Experimental design. Fecal samples will be studied by qRT-PCR. Fecal samples may be subjected to pyrosequencing and selective culturing.
All subjects will fill out a Gastrointestinal Symptom Rating Scale (GSRS) questionnaire (at week GSRS at week 1, 2, 3, 4 and 8, 9, 10 11) to test the acceptance and safety of the strain, and to test if subjects remain eligible for the study. Weeks 1 and 8 are the baseline visits, weeks 4 and 11 are one week after subject stops taking study product. Subjects that have begun or expect to begin antibiotic treatment or that have experienced unacceptable side effects will stop their participation.
- Conditions
- Bacterium; Agent
- Being tested
- Probiotic Powder, Placebo powder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic PowderDietary supplement
Bifidobacterium longum subsp longum AH1206 freeze dried and provided as a powder in a sachet (10^10 cells/sachet)
Placebo powderDietary supplement
powdered maltodextrin inthe same volume and the freeze dried probiotic in a similar size sachet
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Powder | Experimental | Probiotic: Bifidobacterium longum subsp longum AH1206 Receives: Dietary Supplement: Probiotic Powder |
| Placebo Powder | Placebo comparator | Equivalent amount (same volume) of maltodextrin Receives: Dietary Supplement: Placebo powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistence or presence of the probiotic strain Bifidobacterium Longum ssp longum AH1206.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2013
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterium; AgentStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska Lincoln
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens Walter, University of Nebraska Lincoln
- Investigators
- Jens Walter, PhD, Principal investigator, University of Nebraska Lincoln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01650753
- Sponsor's protocol ID
- UNL 222-12 FB
- Status last verified
- Nov 2015
- First submitted
- 23 Jul 2012
- Last updated
- 6 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Evaluation of the Colonization and Persistence of Bifidobacterium Longum Ssp Longum AH1206 in the Gastrointestinal Tract and Its Tolerance by Human Subjects
- ClinicalTrials.gov ID
- NCT01650753
- Acronym / sponsor ID
- UNL 222-12 FB
- Conditions
- Bacterium; Agent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Nebraska LincolnUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 26 Jul 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.
Healthy adults referred to as the absence of intestinal disorders, liver and kidney problems, lactose intolerance, and no use of ongoing medication for chronic diseases will be recruited. This research study will test the persistence of the probiotic (healthy bacterial) strain Bifidobacterium longum spp. longum in the human gastrointestinal tract after it is consumed, how it is tolerated, and its interactions with other micro-organisms already present in your gastrointestinal tract. The strain used is similar to bacteria used in probiotic yogurts, and the species Bifidobacterium is generally regarded as safe. The patient will be asked to will be consume a probiotic powder containing Bifidobacterium longum spp. longum strain AH1206 and a placebo in a random order, with neither the patient nor the investigators knowing the identity of the preparations given. Persistence or presence of the probiotic strain will be based on analysis of fecal (stool or bowel movement) samples provided.
Detailed description
The study will be performed as a 14 week randomized crossover trial with two treatments, one of which is the placebo. The randomization design will be provided by collaborators at Mead Johnson, and the study will be performed double blinded, such that no study staff will be informed about the nature of the product. Each treatment period will consist of a one week baseline period, in which one fecal sample will be collected. This will be followed by a two week feeding period in which the probiotic will be administered at a constant dose of 10^10 cells per day in 50 to 100 ml of either cold or room temperature tab water. At day 7 and 14 (last day of feeding), a fecal sample will be collected. The last sample during feeding will also serve as day 0 of Test of Persistence (TOP) period. Persistence of the probiotic strains will be tested during the TOP period at day 4, 8, 16, and 28 (4 weeks) for a total of 7 fecal samples. The subjects will then crossover to the other treatment and the above fecal sample collections will be repeated. Fecal samples will be provided by the subjects using disposable stool collection containers not longer than 2 hours after defecation. In the lab fecal samples will be stored undiluted (four aliquots) and as 1/10 dilutions in PBS buffer (four aliquots). The investigators will also prepare five tubes with 1 gram aliquots of each fecal sample and will provide these samples de-identified to Mead Johnson Nutrition for future analyses. Experimental design. Fecal samples will be studied by qRT-PCR. Fecal samples may be subjected to pyrosequencing and selective culturing.
All subjects will fill out a Gastrointestinal Symptom Rating Scale (GSRS) questionnaire (at week GSRS at week 1, 2, 3, 4 and 8, 9, 10 11) to test the acceptance and safety of the strain, and to test if subjects remain eligible for the study. Weeks 1 and 8 are the baseline visits, weeks 4 and 11 are one week after subject stops taking study product. Subjects that have begun or expect to begin antibiotic treatment or that have experienced unacceptable side effects will stop their participation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic Powder | Experimental | Dietary Supplement: Probiotic PowderProbiotic: Bifidobacterium longum subsp longum AH1206 |
| Placebo Powder | Placebo comparator | Dietary Supplement: Placebo powderEquivalent amount (same volume) of maltodextrin |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able to give written informed consent and willingness to participate in the study and comply with its procedures.
- Male or Female
- Aged 19 years of age and over.
- Be in generally good health as determined by the investigators. BMI of 18.5-29.9 kg/m2
- Free of any gastrointestinal disorders or complaints, as determined by the Bowel Disease Questionnaire (Talley et al., 1990), at visit 1.
Key exclusion criteria (13 listed)
- Less than 19 years of age.
- Underweighted or obese based on BMI.
- Antibiotic usage 3 months prior to study or during study.
- Significant acute or chronic existing illness [cardiovascular, gastrointestinal, immunological] or a condition which in the investigators judgment, contraindicates involvement in the study.
- Prior gastrointestinal surgery (apart from appendicectomy and hernia repair) or recent unexplained bleeding which, in the Investigator's judgment, contraindicates participation in the study.
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 PowderBifidobacterium longum subsp longum AH1206 freeze dried and provided as a powder in a sachet (10^10 cells/sachet) | Dietary supplement | Probiotic Powder |
| Placebo powderpowdered maltodextrin inthe same volume and the freeze dried probiotic in a similar size sachet | Dietary supplement | Placebo Powder |
Primary outcome
Persistence or presence of the probiotic strain Bifidobacterium Longum ssp longum AH1206.
Time frame: 16 weeks
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 6 Nov 2015.
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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.
Jens Walter, PhD principal investigator
University of Nebraska Lincoln
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Powder in people with Bacterium; Agent, run by University of Nebraska Lincoln.
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 8 inclusion and 13 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 6 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Persistence or presence of the probiotic strain Bifidobacterium Longum ssp longum AH1206. (time frame: 16 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 6 Nov 2015.