Effects of Probiotics in Immune System of Healthy Adults

NCT01479543 | Completed Results DMC

• 1 other identifier: SETOPROB
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Conditions Influencing Health Status

Keywords

Probiotic; Immunity; Gastrointestinal symptoms

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Gastrointestinal and Immune Effects of Probiotics Consumption.

  At Time zero, after 4 weeks, and 2 later.

Study Arms (5)

Group A

EXPERIMENTAL

Volunteers received Probiotic CNCM I-4034.

Other: Probiotic CNCM I-4034

Group B

EXPERIMENTAL

Volunteers receive Probiotic CNCM I-4035.

Other: Probiotic CNCM I-4035

Group C

EXPERIMENTAL

Volunteers are given Probiotic CNCM I-4036.

Other: Probiotic CNCM I-4036

Group D

EXPERIMENTAL

Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.

Other: Probiotics CNCM I-4035 and CNCM I-4036

Group E

PLACEBO COMPARATOR

Volunteers receive a Placebo.

Other: Placebo

Interventions

Probiotic CNCM I-4034 OTHER

Probiotic CNCM I-4034 in a concentration of 9x10E9 cfu (colony forming unit) per day during 28 days.

Also known as: CNCM I-4034

Group A

Probiotic CNCM I-4035 OTHER

9x10E9 cfu (colony forming unit) per day during 28 days.

Also known as: CNCM I-4035

Group B

Probiotic CNCM I-4036 OTHER

9x10E9 cfu (colony forming unit) per day during 28 days.

Also known as: CNCM I-4036

Group C

Probiotics CNCM I-4035 and CNCM I-4036 OTHER

9x10E9 cfu (colony forming unit) per day during 28 days.

Also known as: CNCM I-4035+CNCM I-4036

Group D

Placebo OTHER

Placebo capsule for 28 days.

Also known as: Placebo, group E

Group E

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult
• Age: 18-50 years
• Normal defecation
• Normal blood parameters
• Body Mass Index: 18-30

You may not qualify if:

• Pregnancy
• Lactation
• Antibiotic treatment
• Gastrointestinal disease
• Diarrhoea
• Constipation
• Diabetes
• Abnormal blood pressure
• Allergy
• Smoker

Sponsors & Collaborators

• Hero Institute for Infant Nutrition: lead
• Universidad de Granada: collaborator
• University of Valencia: collaborator
• Universidad de Murcia: collaborator

Study Sites (4)

Granada University

Granada, Granada, 18100, Spain

Location

Hero Institute of Infant Nutrition

Alcantarilla, Murcia, 30820, Spain

Location

Murcia University

Espinardo, Murcia, 30071, Spain

Location

Valencia University

Valencia, Valencia, 46010, Spain

Location

Related Publications (8)

• 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.

  PMID: 20159049 BACKGROUND

• 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.

  PMID: 20691131 BACKGROUND

• 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.

  PMID: 16054520 BACKGROUND

• 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.

  PMID: 18395902 BACKGROUND

• 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.

  PMID: 18336547 BACKGROUND

• 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.

  PMID: 17440520 BACKGROUND

• 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.

  PMID: 26016655 DERIVED

• 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.

  PMID: 24205115 DERIVED

Results Point of Contact

• Title: Esther Matencio Hilla
• Organization: Hero Institute for Infant Nutrition

esther.matencio@hero.es

+0034 968 89 89 00

Study Officials

• Pedro Abellán, PhD

  Hero Institute of Infant Nutrition

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Manager

Study Record Dates

• First Submitted: November 18, 2011
• First Posted: November 24, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: September 5, 2014
• Results First Posted: September 5, 2014

Record last verified: 2014-09

Locations

ES (4)