Effects of Probiotics in Immune System of Healthy Adults
NCT ID: NCT01479543
Last Updated: 2014-09-05
Study Results
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View full resultsBasic Information
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COMPLETED
NA
103 participants
INTERVENTIONAL
2011-11-30
2012-12-31
Brief Summary
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Daily intake of one or several probiotic strains, (CNCM I-4034, CNCM I-4035, CNCM I-4036), increases intestinal microbiota in healthy adults, being safe and well tolerated. The regular intake has positive effects on the gastrointestinal and immune system.
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Detailed Description
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The colonization performed by the strains and the modification of the intestinal microbiota will be evaluated by means of strain identification with RT-PCR equipped with specific primers, and bacterial population counting with in situ immunofluorescence techniques.
The safety of strain intake will be evaluated with physical examination, blood parameters, and test son faeces to check for resistance to ampicillin and tetracycline by lactic flora.
Tolerance will be evaluated by means of the record of gastrointestinal symptoms and the record of aspect and frequency of faeces.
The effect on the systemic and adaptive immune system will be measured by means of lymphocyte populations and plasma cytokine present on blood, IgAs on serum, saliva and faeces. Also AGCC on faeces.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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Group A
Volunteers received Probiotic CNCM I-4034.
Probiotic CNCM I-4034
Probiotic CNCM I-4034 in a concentration of 9x10E9 cfu (colony forming unit) per day during 28 days.
Group B
Volunteers receive Probiotic CNCM I-4035.
Probiotic CNCM I-4035
9x10E9 cfu (colony forming unit) per day during 28 days.
Group C
Volunteers are given Probiotic CNCM I-4036.
Probiotic CNCM I-4036
9x10E9 cfu (colony forming unit) per day during 28 days.
Group D
Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.
Probiotics CNCM I-4035 and CNCM I-4036
9x10E9 cfu (colony forming unit) per day during 28 days.
Group E
Volunteers receive a Placebo.
Placebo
Placebo capsule for 28 days.
Interventions
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Probiotic CNCM I-4034
Probiotic CNCM I-4034 in a concentration of 9x10E9 cfu (colony forming unit) per day during 28 days.
Probiotic CNCM I-4035
9x10E9 cfu (colony forming unit) per day during 28 days.
Probiotic CNCM I-4036
9x10E9 cfu (colony forming unit) per day during 28 days.
Probiotics CNCM I-4035 and CNCM I-4036
9x10E9 cfu (colony forming unit) per day during 28 days.
Placebo
Placebo capsule for 28 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age: 18-50 years
* Normal defecation
* Normal blood parameters
* Body Mass Index: 18-30
Exclusion Criteria
* Lactation
* Antibiotic treatment
* Gastrointestinal disease
* Diarrhoea
* Constipation
* Diabetes
* Abnormal blood pressure
* Allergy
* Smoker
18 Years
50 Years
ALL
Yes
Sponsors
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Universidad de Granada
OTHER
University of Valencia
OTHER
Universidad de Murcia
OTHER
Hero Institute for Infant Nutrition
INDUSTRY
Responsible Party
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Pedro Abellan
Project Manager
Principal Investigators
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Pedro Abellán, PhD
Role: STUDY_CHAIR
Hero Institute of Infant Nutrition
Locations
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Granada University
Granada, Granada, Spain
Hero Institute of Infant Nutrition
Alcantarilla, Murcia, Spain
Murcia University
Espinardo, Murcia, Spain
Valencia University
Valencia, Valencia, Spain
Countries
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References
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Sierra S, Lara-Villoslada F, Sempere L, Olivares M, Boza J, Xaus J. Intestinal and immunological effects of daily oral administration of Lactobacillus salivarius CECT5713 to healthy adults. Anaerobe. 2010 Jun;16(3):195-200. doi: 10.1016/j.anaerobe.2010.02.001. Epub 2010 Feb 14.
Wind RD, Tolboom H, Klare I, Huys G, Knol J. Tolerance and safety of the potentially probiotic strain Lactobacillus rhamnosus PRSF-L477: a randomised, double-blind placebo-controlled trial in healthy volunteers. Br J Nutr. 2010 Dec;104(12):1806-16. doi: 10.1017/S0007114510002746. Epub 2010 Aug 9.
de Vrese M, Winkler P, Rautenberg P, Harder T, Noah C, Laue C, Ott S, Hampe J, Schreiber S, Heller K, Schrezenmeir J. Effect of Lactobacillus gasseri PA 16/8, Bifidobacterium longum SP 07/3, B. bifidum MF 20/5 on common cold episodes: a double blind, randomized, controlled trial. Clin Nutr. 2005 Aug;24(4):481-91. doi: 10.1016/j.clnu.2005.02.006. Epub 2005 Apr 21.
Kekkonen RA, Lummela N, Karjalainen H, Latvala S, Tynkkynen S, Jarvenpaa S, Kautiainen H, Julkunen I, Vapaatalo H, Korpela R. Probiotic intervention has strain-specific anti-inflammatory effects in healthy adults. World J Gastroenterol. 2008 Apr 7;14(13):2029-36. doi: 10.3748/wjg.14.2029.
Ouwehand AC, Bergsma N, Parhiala R, Lahtinen S, Gueimonde M, Finne-Soveri H, Strandberg T, Pitkala K, Salminen S. Bifidobacterium microbiota and parameters of immune function in elderly subjects. FEMS Immunol Med Microbiol. 2008 Jun;53(1):18-25. doi: 10.1111/j.1574-695X.2008.00392.x. Epub 2008 Mar 10.
Klein A, Friedrich U, Vogelsang H, Jahreis G. Lactobacillus acidophilus 74-2 and Bifidobacterium animalis subsp lactis DGCC 420 modulate unspecific cellular immune response in healthy adults. Eur J Clin Nutr. 2008 May;62(5):584-93. doi: 10.1038/sj.ejcn.1602761. Epub 2007 Apr 18.
Plaza-Diaz J, Fernandez-Caballero JA, Chueca N, Garcia F, Gomez-Llorente C, Saez-Lara MJ, Fontana L, Gil A. Pyrosequencing analysis reveals changes in intestinal microbiota of healthy adults who received a daily dose of immunomodulatory probiotic strains. Nutrients. 2015 May 26;7(6):3999-4015. doi: 10.3390/nu7063999.
Plaza-Diaz J, Gomez-Llorente C, Campana-Martin L, Matencio E, Ortuno I, Martinez-Silla R, Gomez-Gallego C, Periago MJ, Ros G, Chenoll E, Genoves S, Casinos B, Silva A, Corella D, Portoles O, Romero F, Ramon D, Perez de la Cruz A, Gil A, Fontana L. Safety and immunomodulatory effects of three probiotic strains isolated from the feces of breast-fed infants in healthy adults: SETOPROB study. PLoS One. 2013 Oct 28;8(10):e78111. doi: 10.1371/journal.pone.0078111. eCollection 2013.
Other Identifiers
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SETOPROB
Identifier Type: -
Identifier Source: org_study_id
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