Effects of Probiotics in Immune System of Healthy Adults

Conditions Influencing Health Status Clinical Trial

— SETOPROB  

Official title:

Colonization, Safety, Tolerance, and Effects of Three Probiotic Strains on the Immune System of Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01479543
• Other study ID #: SETOPROB
• Status: Completed
• Phase: N/A
• First received: November 18, 2011
• Last updated: September 4, 2014
• Start date: November 2011
• Est. completion date: December 2012

Study information

• Verified date: September 2014
• Source: Hero Institute for Infant Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The present report describes the design of a clinical trial performed on healthy adult individuals to check whether the daily intake of the new Hero strains contribute to intestinal colonization, under safe and tolerable conditions, with a positive contribution to health and wellbeing of healthy individuals.

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.

Description:

The project will be based on a double-blind, randomized, and placebo-controlled clinical trial. It will be multi-Centre, with four groups plus a control group.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy adult

• Age: 18-50 years

• Normal defecation

• Normal blood parameters

• Body Mass Index: 18-30

Exclusion Criteria:

• Pregnancy

• Lactation

• Antibiotic treatment

• Gastrointestinal disease

• Diarrhoea

• Constipation

• Diabetes

• Abnormal blood pressure

• Allergy

• Smoker

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Conditions Influencing Health Status

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Spain	Hero Institute of Infant Nutrition	Alcantarilla	Murcia
Spain	Murcia University	Espinardo	Murcia
Spain	Granada University	Granada
Spain	Valencia University	Valencia

Sponsors (4)

Lead Sponsor	Collaborator
Hero Institute for Infant Nutrition	Universidad de Granada, Universidad de Murcia, University of Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. Epub 2005 Apr 21. — View Citation

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. — View Citation

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. Epub 2007 Apr 18. — View Citation

Ouwehand AC, Bergsma N, Parhiala R, Lahtinen S, Gueimonde M, Finne-Soveri H, Strandberg T, Pitkälä 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal Tolerance After Probiotic Consumption.	Tolerance of these probiotic strains was determined using the gastrointestinal symptom rating scale (GSRS), daily recorded gastrointestinal symptoms and defecation frequency.Intolerance was defined as a symptom score of 2 or higher on the GSRS. The unit of measure is the "number of participants" was tolerant to the intervention.	4 weeks of the treatments. Daily recorded.	No
Secondary	Gastrointestinal and Immune Effects of Probiotics Consumption.	Effect on the systemic and adaptive immune system. This will be measured by means of lymphocite populations and plasma cytokine present on blood, IgAs on serum (at zero time and after four weeks of treatment), IgAs on saliva and faeces and AGCC (at zero time and after four weeks and two more weeks).; Gastrointestinal effects will be measured by means of gastrointestinal symptoms record and frequency and aspect of faeces, during the treatment and the following two weeks (wash-out period).	At Time zero, after 4 weeks, and 2 later.	Yes

External Links

•   Hero Institute of Infant Nutrition