Effects of Probiotics in Immune System of Healthy Adults (SETOPROB)
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| ClinicalTrials.gov Identifier: NCT01479543 |
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Recruitment Status :
Completed
First Posted : November 24, 2011
Results First Posted : September 5, 2014
Last Update Posted : September 5, 2014
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Conditions Influencing Health Status | Other: Probiotic CNCM I-4034 Other: Probiotic CNCM I-4035 Other: Probiotic CNCM I-4036 Other: Probiotics CNCM I-4035 and CNCM I-4036 Other: Placebo | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 103 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Official Title: | Colonization, Safety, Tolerance, and Effects of Three Probiotic Strains on the Immune System of Healthy Adults |
| Study Start Date : | November 2011 |
| Actual Primary Completion Date : | December 2011 |
| Actual Study Completion Date : | December 2012 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Group A
Volunteers received Probiotic CNCM I-4034.
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Other: Probiotic CNCM I-4034
Probiotic CNCM I-4034 in a concentration of 9x10E9 cfu (colony forming unit) per day during 28 days.
Other Name: CNCM I-4034 |
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Experimental: Group B
Volunteers receive Probiotic CNCM I-4035.
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Other: Probiotic CNCM I-4035
9x10E9 cfu (colony forming unit) per day during 28 days.
Other Name: CNCM I-4035 |
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Experimental: Group C
Volunteers are given Probiotic CNCM I-4036.
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Other: Probiotic CNCM I-4036
9x10E9 cfu (colony forming unit) per day during 28 days.
Other Name: CNCM I-4036 |
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Experimental: Group D
Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.
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Other: Probiotics CNCM I-4035 and CNCM I-4036
9x10E9 cfu (colony forming unit) per day during 28 days.
Other Name: CNCM I-4035+CNCM I-4036 |
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Placebo Comparator: Group E
Volunteers receive a Placebo.
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Other: Placebo
Placebo capsule for 28 days.
Other Name: Placebo, group E |
- 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.
- Gastrointestinal and Immune Effects of Probiotics Consumption. [ Time Frame: At Time zero, after 4 weeks, and 2 later. ]
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).
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| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01479543
| Spain | |
| Hero Institute of Infant Nutrition | |
| Alcantarilla, Murcia, Spain, 30820 | |
| Murcia University | |
| Espinardo, Murcia, Spain, 30071 | |
| Granada University | |
| Granada, Spain, 18100 | |
| Valencia University | |
| Valencia, Spain, 46010 | |
| Study Chair: | Pedro Abellán, PhD | Hero Institute of Infant Nutrition |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pedro Abellan, Project Manager, Hero Institute for Infant Nutrition |
| ClinicalTrials.gov Identifier: | NCT01479543 |
| Other Study ID Numbers: |
SETOPROB |
| First Posted: | November 24, 2011 Key Record Dates |
| Results First Posted: | September 5, 2014 |
| Last Update Posted: | September 5, 2014 |
| Last Verified: | September 2014 |
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Probiotic Immunity Gastrointestinal symptoms |