Effects of Probiotics in Immune System of Healthy Adults (SETOPROB)
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Purpose
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 | Intervention | 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 capsule |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) |
| Official Title: | Colonization, Safety, Tolerance, and Effects of Three Probiotic Strains on the Immune System of Healthy Adults |
- Colonization after probiotic consumption. [ Time Frame: Changes from baseline in microbiota at 30 days and 45 days ] [ Designated as safety issue: Yes ]The colonization of these probiotic strains in the intestinal microbiota will be measured in feces by means of Real Time Polimerase Chain Reaction.Tolerance will be measured by means of number of adverse events and safety by means of physical examination, blood biochemistry and haemogram and tolerance will be tested reporting of any symptoms of gastrointestinal discomfort and frecuency and aspects of stools daily recorded.
- Gastrointestinal and Immune Effects of Probiotics consumption. [ Time Frame: At Time zero, after 4 weeks, and 2 later. ] [ Designated as safety issue: Yes ]
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).
| Estimated Enrollment: | 105 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group A
Volunteers are given strain CNCM I-4034.
|
Other: Probiotic CNCM I-4034
9x10E9 cfu (colony forming unit) per day during 28 days.
Other Name: CNCM I-4034
|
|
Experimental: Group B
Volunteers receive Probiotic CNCM I-4035.
|
Other: Probiotic CNCM I-4035
9x10E9 cfu (colony forming unit) per day during 28 days.
Other Name: CNCM I-4035
|
|
Experimental: Group C
Volunteers are given Probiotic CNCM I-4036.
|
Other: Probiotic CNCM I-4036
9x10E9 cfu (colony forming unit) per day during 28 days.
Other Name: CNCM I-4036
|
|
Experimental: Group D
Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.
|
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
|
|
Placebo Comparator: Group E
Volunteers receive a placebo.
|
Other: Placebo capsule
Placebo capsule for 28 days.
Other Name: Placebo
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Contact: Esther Matencio, Bachelor | 34.968.89.89.00 ext 1166 | esther.matencio@hero.es |
| Spain | |
| Hero Institute of Infant Nutrition | Recruiting |
| Alcantarilla, Murcia, Spain, 30820 | |
| Contact: Esther Matencio, Bachelor 34.968.89.89.00 ext 1166 esther.matencio@hero.es | |
| Contact: Fernando Romero, PhD 34.968.89.89.00 ext 1220 fernando.romero@hero.es | |
| Sub-Investigator: Fernando Romero, PhD | |
| Sub-Investigator: Francisco Sáez, PhD | |
| Sub-Investigator: María José Bernal, PhD | |
| Sub-Investigator: Esther Matencio, Bachelor | |
| Sub-Investigator: Rosario Martínez, Bachelor | |
| Sub-Investigator: Inmaculada Ortuño, Bachelor | |
| Sub-Investigator: Luis Manuel Sánchez, Bachelor | |
| Principal Investigator: Pedro Abellán, PhD | |
| Murcia University | Recruiting |
| Espinardo, Murcia, Spain, 30071 | |
| Contact: Gaspar Ros, PhD 34.868.88.47.94 gros@um.es | |
| Contact: María Jesús Periago, PhD 34.868.88.47.94 mjperi@um.es | |
| Principal Investigator: Gaspar Ros, PhD | |
| Sub-Investigator: María Jesús Periago, PhD | |
| Sub-Investigator: Carlos Gómez, Bachelor | |
| Granada University | Recruiting |
| Granada, Spain, 18100 | |
| Contact: Angel Gil, PhD 34.958.24.10.00 agil@ugr.es | |
| Contact: Carolina Gómez, PhD 34.958.24.10.00 gomezll@ugr.es | |
| Principal Investigator: Angel Gil, PhD | |
| Sub-Investigator: Julio Plaza, Bachelor | |
| Sub-Investigator: Carolina Gómez, PhD | |
| Sub-Investigator: Miriam Bermúdez, Bachelor | |
| Valencia University | Recruiting |
| Valencia, Spain, 46010 | |
| Contact: Dolores Corella, PhD 34.963.86.44.17 dolores.corella@uv.es | |
| Contact: Olga Portolés, PhD 34.963.86.44.17 olga.portoles@uv.es | |
| Principal Investigator: Dolores Corella, PhD | |
| Sub-Investigator: Olga Portolés, PhD | |
| Sub-Investigator: Salvador Genovés, Bachelor | |
| Sub-Investigator: Empar Chernoll, PhD | |
| Sub-Investigator: Daniel Ramón, PhD | |
| Study Chair: | Pedro Abellán, PhD | Hero Institute of Infant Nutrition |
More Information
Additional Information:
Publications:
| Responsible Party: | Pedro Abellan, Project Manager, Hero Institute for Infant Nutrition |
| ClinicalTrials.gov Identifier: | NCT01479543 History of Changes |
| Other Study ID Numbers: | SETOPROB |
| Study First Received: | November 18, 2011 |
| Last Updated: | November 23, 2011 |
| Health Authority: | Spain: Ethics Committee |
Keywords provided by Hero Institute for Infant Nutrition:
|
Probiotic Immunity Gastrointestinal symptoms |
ClinicalTrials.gov processed this record on May 16, 2013