NCT03952988 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Almeida CC, Lorena SL, Pavan CR, Akasaka HM, Mesquita MA
Beneficial effects of long-term consumption of a probiotic combination of Lactobacillus casei Shirota and Bifidobacterium breve Yakult may persist after suspension of therapy in lactose-intolerant
Gargari G, Taverniti V, Balzaretti S, Ferrario C, Gardana C, Simonetti P, Guglielmetti S
Consumption of a Bifidobacterium bifidum Strain for 4 Weeks Modulates Dominant Intestinal Bacterial Taxa and Fecal Butyrate in Healthy Adults. Appl Environ Microbiol
Hsu CA, Yu RC, Lee SL, Chou CC
Cultural condition affecting the growth and production of beta-galactosidase by Bifidobacterium longum CCRC 15708 in a jar fermenter. Int J Food Microbiol. 2007 May 1;116(1):186-9. Epub 2007 Jan 19.
Jiang T, Mustapha A, Savaiano DA
Improvement of lactose digestion in humans by ingestion of unfermented milk containing Bifidobacterium longum. J Dairy Sci. 1996 May;79(5):750-7.
Marteau P, Pochart P, Flourié B, Pellier P, Santos L, Desjeux JF, Rambaud JC
Effect of chronic ingestion of a fermented dairy product containing Lactobacillus acidophilus and Bifidobacterium bifidum on metabolic activities of the colonic flora in humans.
Pelletier X, Laure-Boussuge S, Donazzolo Y
Hydrogen excretion upon ingestion of dairy products in lactose-intolerant male subjects: importance of the live flora. Eur J Clin Nutr. 2001 Jun;55(6):509-12.
Turroni F, Duranti S, Bottacini F, Guglielmetti S, Van Sinderen D, Ventura M
Bifidobacterium bifidum as an example of a specialized human gut commensal. Front Microbiol. 2014 Aug 21;5:437. doi: 10.3389/fmicb.2014.00437. eCollection 2014. Review.

Effect of the Consumption of a Probiotic (B. Bifidum 900791)-Containing Ice-cream in Adult With Hypolactasia and Lactose Intolerance

Details for clinical trial NCT03952988

Clinical trial NCT03952988 - References