drugset / Trial / NCT02113072
Recurrent Wheezing in Infants: Risk Factors and Prevention With Probiotics.
Phase 3
Completed
60 enrolled
Federal University of Pernambuco
Conselho Nacional de Desenvolvimento Científico e Tecnológico · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to evaluate whether Probiotics promote reduction of recurrent wheezing in infants, stimulating the immune system to Th1 response.
Timeline
- Start
- 2014-04
- Primary completion
- 2014-08
- Completion
- 2014-11
Publications
- Background Rose MA, Stieglitz F, Koksal A, Schubert R, Schulze J, Zielen S. Efficacy of probiotic Lactobacillus GG on allergic sensitization and asthma in infants at risk. Clin Exp Allergy. 2010 Sep;40(9):1398-405. doi: 10.1111/j.1365-2222.2010.03560.x. Epub 2010 Jun 28.
- Background Kopp MV, Hennemuth I, Heinzmann A, Urbanek R. Randomized, double-blind, placebo-controlled trial of probiotics for primary prevention: no clinical effects of Lactobacillus GG supplementation. Pediatrics. 2008 Apr;121(4):e850-6. doi: 10.1542/peds.2007-1492. Epub 2008 Mar 10.
- Background Ozdemir O, Erol AY. Preventative and therapeutic probiotic use in allergic skin conditions: experimental and clinical findings. Biomed Res Int. 2013;2013:932391. doi: 10.1155/2013/932391. Epub 2013 Sep 1.
- Background Ozdemir O. Any role for probiotics in the therapy or prevention of autoimmune diseases? Up-to-date review. J Complement Integr Med. 2013 Aug 6;10:/j/jcim.2013.10.issue-1/jcim-2012-0054/jcim-2012-0054.xml. doi: 10.1515/jcim-2012-0054.
- Background Isolauri E, Rautava S, Salminen S. Probiotics in the development and treatment of allergic disease. Gastroenterol Clin North Am. 2012 Dec;41(4):747-62. doi: 10.1016/j.gtc.2012.08.007.
- Background Roessler A, Forssten SD, Glei M, Ouwehand AC, Jahreis G. The effect of probiotics on faecal microbiota and genotoxic activity of faecal water in patients with atopic dermatitis: a randomized, placebo-controlled study. Clin Nutr. 2012 Feb;31(1):22-9. doi: 10.1016/j.clnu.2011.08.012. Epub 2011 Oct 2.
- Background Azad MB, Coneys JG, Kozyrskyj AL, Field CJ, Ramsey CD, Becker AB, Friesen C, Abou-Setta AM, Zarychanski R. Probiotic supplementation during pregnancy or infancy for the prevention of asthma and wheeze: systematic review and meta-analysis. BMJ. 2013 Dec 4;347:f6471. doi: 10.1136/bmj.f6471.
- Background Abrahamsson TR, Jakobsson T, Bjorksten B, Oldaeus G, Jenmalm MC. No effect of probiotics on respiratory allergies: a seven-year follow-up of a randomized controlled trial in infancy. Pediatr Allergy Immunol. 2013 Sep;24(6):556-61. doi: 10.1111/pai.12104. Epub 2013 Jul 31.
- Background West CE, Hammarstrom ML, Hernell O. Probiotics in primary prevention of allergic disease--follow-up at 8-9 years of age. Allergy. 2013 Aug;68(8):1015-20. doi: 10.1111/all.12191. Epub 2013 Jul 30.
- Background Ismail IH, Licciardi PV, Tang ML. Probiotic effects in allergic disease. J Paediatr Child Health. 2013 Sep;49(9):709-15. doi: 10.1111/jpc.12175. Epub 2013 Apr 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Probiotics | Other / unclassified | 1 g | Oral |
| Background | Beclomethasone | Small molecule | 50 ug | Inhaled |