Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Universidad de Granada | OTHER |
| University of Valencia | OTHER |
| Universidad de Murcia | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Volunteers received Probiotic CNCM I-4034. |
|
| Group B | Experimental | Volunteers receive Probiotic CNCM I-4035. |
|
| Group C | Experimental | Volunteers are given Probiotic CNCM I-4036. |
|
| Group D | Experimental | Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036. |
|
| Group E | Placebo Comparator | Volunteers receive a Placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic CNCM I-4034 | Other | Probiotic CNCM I-4034 in a concentration of 9x10E9 cfu (colony forming unit) per day during 28 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pedro Abellán, PhD | Hero Institute of Infant Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Granada University | Granada | Granada | 18100 | Spain | ||
| Hero Institute of Infant Nutrition |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20159049 | Background | 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. | |
| 20691131 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group A | Volunteers are given strain CNCM I-4034. Probiotic CNCM I-4034: 9x10E9 cfu (colony forming unit) per day during 28 days. |
| FG001 | Group B | Volunteers receive Probiotic CNCM I-4035. Probiotic CNCM I-4035: 9x10E9 cfu (colony forming unit) per day during 28 days. |
| FG002 | Group C | Volunteers are given Probiotic CNCM I-4036. Probiotic CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days. |
| FG003 | 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. |
| FG004 | Group E | Volunteers receive a placebo. Placebo capsule: Placebo capsule for 28 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The average age was 28 years in all groups. Gender male/female in Probiotic groups 37/43 and placebo groups 9/11. Región of enrollment were Granada, Murcia and Valencia cities placed in southeast of Spain.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group A | Volunteers are given strain CNCM I-4034. Probiotic CNCM I-4034: 9x10E9 cfu (colony forming unit) per day during 28 days. |
| BG001 | Group B | Volunteers receive Probiotic CNCM I-4035. Probiotic CNCM I-4035: 9x10E9 cfu (colony forming unit) per day during 28 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Calculation of simple size was based on the variance in the probiotic strain count (log strain CFU/g) in feces and a difference of 25% compared with the placebo. alfa: 0.05 power 90% | Posted | Number | participants | 4 weeks of the treatments. Daily recorded. |
|
Adverse events were collected during the first washout (15 days) intervention period (28 days) and second wasout period (15 days). The assessment was performed using Gastrointestinal Symptom Rating Scale questionnaire (GSRS)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A | Volunteers are given strain CNCM I-4034. Probiotic CNCM I-4034: 9x10E9 cfu (colony forming unit) per day during 28 days. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal pain, nausea and vomiting, hard stools, acid regurgitation, eructation... | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Esther Matencio Hilla | Hero Institute for Infant Nutrition | +0034 968 89 89 00 | esther.matencio@hero.es |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Probiotic CNCM I-4035 | Other | 9x10E9 cfu (colony forming unit) per day during 28 days. |
|
|
| Probiotic CNCM I-4036 | Other | 9x10E9 cfu (colony forming unit) per day during 28 days. |
|
|
| Probiotics CNCM I-4035 and CNCM I-4036 | Other | 9x10E9 cfu (colony forming unit) per day during 28 days. |
|
|
| Placebo | Other | Placebo capsule for 28 days. |
|
|
| At Time zero, after 4 weeks, and 2 later. |
| Alcantarilla |
| Murcia |
| 30820 |
| Spain |
| Murcia University | Espinardo | Murcia | 30071 | Spain |
| Valencia University | Valencia | Valencia | 46010 | Spain |
| 16054520 | 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. |
| 18395902 | 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. |
| 18336547 | 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. |
| 17440520 | 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. |
| 26016655 | Derived | 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. |
| 24205115 | 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. |
| BG002 | Group C | Volunteers are given Probiotic CNCM I-4036. Probiotic CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days. |
| BG003 | 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. |
| BG004 | Group E | Volunteers receive a placebo. Placebo capsule: Placebo capsule for 28 days. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Group B |
Volunteers receive Probiotic CNCM I-4035. Probiotic CNCM I-4035: 9x10E9 cfu (colony forming unit) per day during 28 days. |
| OG002 | Group C | Volunteers are given Probiotic CNCM I-4036. Probiotic CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days. |
| OG003 | 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. |
| OG004 | Group E | Volunteers receive a placebo. Placebo capsule: Placebo capsule for 28 days. |
|
|
| 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). | Not Posted | At Time zero, after 4 weeks, and 2 later. |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Group B | Volunteers receive Probiotic CNCM I-4035. Probiotic CNCM I-4035: 9x10E9 cfu (colony forming unit) per day during 28 days. | 0 | 20 | 0 | 20 |
| EG002 | Group C | Volunteers are given Probiotic CNCM I-4036. Probiotic CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days. | 0 | 20 | 0 | 20 |
| EG003 | 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. | 0 | 20 | 0 | 20 |
| EG004 | Group E | Volunteers receive a placebo. Placebo capsule: Placebo capsule for 28 days. | 0 | 20 | 0 | 20 |
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release.