- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01650753
Colonization and Persistence of Bifidobacterium Longum
Quantitative Evaluation of the Colonization and Persistence of Bifidobacterium Longum Ssp Longum AH1206 in the Gastrointestinal Tract and Its Tolerance by Human Subjects
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Probiotic Powder
Probiotic: Bifidobacterium longum subsp longum AH1206
|
Bifidobacterium longum subsp longum AH1206 freeze dried and provided as a powder in a sachet (10^10 cells/sachet)
|
PLACEBO_COMPARATOR: Placebo Powder
Equivalent amount (same volume) of maltodextrin
|
powdered maltodextrin inthe same volume and the freeze dried probiotic in a similar size sachet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Persistence or presence of the probiotic strain Bifidobacterium Longum ssp longum AH1206.
Time Frame: 16 weeks
|
16 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jens Walter, PhD, University of Nebraska Lincoln
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UNL 222-12 FB
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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