Conditions Influencing Health StatusSETOPROBNCT01479543
Effects of Probiotics in Immune System of Healthy Adults
A study testing Probiotic CNCM I-4034, Probiotic CNCM I-4035 and Probiotic CNCM I-4036 in people with Conditions Influencing Health Status, run by Hero Institute for Infant Nutrition at 4 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Conditions Influencing Health Status
- What is being tested?
- Probiotic CNCM I-4034, Probiotic CNCM I-4035 and Probiotic CNCM I-4036
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 4 sitesSpain
- Study dates
- Nov 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult
- Age: 18-50 years
- Normal defecation
- Normal blood parameters
- Body Mass Index: 18-30
Who cannot join
- Pregnancy
- Lactation
- Antibiotic treatment
- Gastrointestinal disease
- Diarrhoea
- Constipation
Show all 10Show fewer
- Diabetes
- Abnormal blood pressure
- Allergy
- Smoker
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hero Institute of Infant Nutrition
Alcantarilla, Murcia, 30820
Murcia University
Espinardo, Murcia, 30071
Granada University
Granada, Granada, 18100
Valencia University
Valencia, Valencia, 46010
About this study
Official title: Colonization, Safety, Tolerance, and Effects of Three Probiotic Strains on the Immune System of Healthy Adults
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.
Read the detailed 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.
- Conditions
- Conditions Influencing Health Status
- Being tested
- Probiotic CNCM I-4034, Probiotic CNCM I-4035, Probiotic CNCM I-4036, Probiotics CNCM I-4035 and CNCM I-4036, Placebo
- Keywords
- Probiotic, Immunity, Gastrointestinal symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic CNCM I-4034Other
Also called CNCM I-4034
Probiotic CNCM I-4034 in a concentration of 9x10E9 cfu (colony forming unit) per day during 28 days.
Probiotic CNCM I-4035Other
Also called CNCM I-4035
9x10E9 cfu (colony forming unit) per day during 28 days.
Probiotic CNCM I-4036Other
Also called CNCM I-4036
9x10E9 cfu (colony forming unit) per day during 28 days.
Probiotics CNCM I-4035 and CNCM I-4036Other
Also called CNCM I-4035+CNCM I-4036
9x10E9 cfu (colony forming unit) per day during 28 days.
PlaceboOther
Also called Placebo, group E
Placebo capsule for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Volunteers received Probiotic CNCM I-4034. Receives: Other: Probiotic CNCM I-4034 |
| Group B | Experimental | Volunteers receive Probiotic CNCM I-4035. Receives: Other: Probiotic CNCM I-4035 |
| Group C | Experimental | Volunteers are given Probiotic CNCM I-4036. Receives: Other: Probiotic CNCM I-4036 |
| Group D | Experimental | Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036. Receives: Other: Probiotics CNCM I-4035 and CNCM I-4036 |
| Group E | Placebo comparator | Volunteers receive a Placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks of the treatments. Daily recorded.
Secondary outcomes (1)
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).
Measured: At Time zero, after 4 weeks, and 2 later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Conditions Influencing Health StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hero Institute for Infant Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universidad de Granada, University of Valencia, Universidad de Murcia
- Responsible party
- Principal investigator, Pedro Abellan, Hero Institute for Infant Nutrition
- Investigators
- Pedro Abellán, PhD, Study chair, Hero Institute of Infant Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01479543
- Sponsor's protocol ID
- SETOPROB
- Acronym
- SETOPROB
- Status last verified
- Sep 2014
- First submitted
- 18 Nov 2011
- Last updated
- 5 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 20159049Wind 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.
PubMed 20691131de 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.
PubMed 16054520Kekkonen 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.
PubMed 18395902Ouwehand 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.
PubMed 18336547Klein 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.
PubMed 17440520Plaza-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.
PubMed 26016655Plaza-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.
PubMed 24205115
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colonization, Safety, Tolerance, and Effects of Three Probiotic Strains on the Immune System of Healthy Adults
- ClinicalTrials.gov ID
- NCT01479543
- Acronym / sponsor ID
- SETOPROB / SETOPROB
- Conditions
- Conditions Influencing Health Status
- Keywords
- Probiotic, Immunity, Gastrointestinal symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Hero Institute for Infant NutritionIndustry (pharma, biotech, devices)
- Collaborators
- Universidad de Granada, University of Valencia, Universidad de Murcia
- Study start
- Nov 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 24 Nov 2011 (estimated)
- Results
- Posted 5 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Probiotic CNCM I-4034Volunteers received Probiotic CNCM I-4034. |
| Group B | Experimental | Other: Probiotic CNCM I-4035Volunteers receive Probiotic CNCM I-4035. |
| Group C | Experimental | Other: Probiotic CNCM I-4036Volunteers are given Probiotic CNCM I-4036. |
| Group D | Experimental | Other: Probiotics CNCM I-4035 and CNCM I-4036Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036. |
| Group E | Placebo comparator | Other: PlaceboVolunteers receive a Placebo. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adult
- Age: 18-50 years
- Normal defecation
- Normal blood parameters
- Body Mass Index: 18-30
Key exclusion criteria (10 listed)
- Pregnancy
- Lactation
- Antibiotic treatment
- Gastrointestinal disease
- Diarrhoea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic CNCM I-4034Also: CNCM I-4034Probiotic CNCM I-4034 in a concentration of 9x10E9 cfu (colony forming unit) per day during 28 days. | Other | Group A |
| Probiotic CNCM I-4035Also: CNCM I-40359x10E9 cfu (colony forming unit) per day during 28 days. | Other | Group B |
| Probiotic CNCM I-4036Also: CNCM I-40369x10E9 cfu (colony forming unit) per day during 28 days. | Other | Group C |
| Probiotics CNCM I-4035 and CNCM I-4036Also: CNCM I-4035+CNCM I-40369x10E9 cfu (colony forming unit) per day during 28 days. | Other | Group D |
| PlaceboAlso: Placebo, group EPlacebo capsule for 28 days. | Other | Group E |
Primary outcome
Gastrointestinal Tolerance After Probiotic Consumption.
Time frame: 4 weeks of the treatments. Daily recorded.
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.
1 secondary outcome
Gastrointestinal and Immune Effects of Probiotics Consumption.
Time frame: At Time zero, after 4 weeks, and 2 later.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20159049Sierra 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.
- Background: PubMed 20691131Wind 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.
- Background: PubMed 16054520de 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.
- Background: PubMed 18395902Kekkonen 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.
- Background: PubMed 18336547Ouwehand 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.
- Background: PubMed 17440520Klein 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.
- Derived from this study: PubMed 26016655Plaza-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.
- Derived from this study: PubMed 24205115Plaza-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.
- Hero Institute of Infant NutritionLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Abellán, PhD study chair
Hero Institute of Infant Nutrition
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic CNCM I-4034, Probiotic CNCM I-4035 and Probiotic CNCM I-4036 in people with Conditions Influencing Health Status, run by Hero Institute for Infant Nutrition at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal Tolerance After Probiotic Consumption. (time frame: 4 weeks of the treatments. Daily recorded.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01479543, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2014.