NCT06154525 - 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)

Bekkali NL, Bongers ME, Van den Berg MM, Liem O, Benninga MA
The role of a probiotics mixture in the treatment of childhood constipation: a pilot study. Nutr J. 2007 Aug 4;6:17. doi: 10.1186/1475-2891-6-17.
Chang CW, Chen MJ, Shih SC, Chang CW, Chiau JC, Lee HC, Lin YS, Lin WC, Wang HY
Bacillus coagulans (PROBACI) in treating constipation-dominant functional bowel disorders. Medicine (Baltimore). 2020 May;99(19):e20098. doi: 10.1097/MD.0000000000020098.
Dong M, Wu Y, Zhang M, Chen P, Zhang Z, Wang S
Effect of probiotics intake on constipation in children: an umbrella review. Front Nutr. 2023 Sep 1;10:1218909. doi: 10.3389/fnut.2023.1218909. eCollection 2023.
Freedman KE, Hill JL, Wei Y, Vazquez AR, Grubb DS, Trotter RE, Wrigley SD, Johnson SA, Foster MT, Weir TL
Examining the Gastrointestinal and Immunomodulatory Effects of the Novel Probiotic Bacillus subtilis DE111. Int J Mol Sci. 2021 Feb 28;22(5):2453. doi: 10.3390/ijms22052453.
Huang R, Hu J
Positive Effect of Probiotics on Constipation in Children: A Systematic Review and Meta-Analysis of Six Randomized Controlled Trials. Front Cell Infect Microbiol. 2017 Apr 28;7:153. doi: 10.3389/fcimb.2017.00153. eCollection 2017.
Levy EI, Lemmens R, Vandenplas Y, Devreker T
Functional constipation in children: challenges and solutions. Pediatric Health Med Ther. 2017 Mar 9;8:19-27. doi: 10.2147/PHMT.S110940. eCollection 2017.

Evaluating the Effectiveness of the LiveSpo® Preg-Mom and LiveSpo® KIDS Spore Probiotics in Supporting the Reduction of Constipation, Anorexia, and Slow Weight Gain in Children Aged 24-60 Months

Details for clinical trial NCT06154525

Clinical trial NCT06154525 - References