Bacterium; Agent Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
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