Status:
COMPLETED
Effects of Probiotics in Immune System of Healthy Adults
Lead Sponsor:
Hero Institute for Infant Nutrition
Collaborating Sponsors:
Universidad de Granada
University of Valencia
Conditions:
Conditions Influencing Health Status
Eligibility:
All Genders
18-50 years
Phase:
NA
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, unde...
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 strai...
Eligibility Criteria
Inclusion
- Healthy adult
- Age: 18-50 years
- Normal defecation
- Normal blood parameters
- Body Mass Index: 18-30
Exclusion
- Pregnancy
- Lactation
- Antibiotic treatment
- Gastrointestinal disease
- Diarrhoea
- Constipation
- Diabetes
- Abnormal blood pressure
- Allergy
- Smoker
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT01479543
Start Date
November 1 2011
End Date
December 1 2012
Last Update
September 5 2014
Active Locations (4)
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1
Granada University
Granada, Granada, Spain, 18100
2
Hero Institute of Infant Nutrition
Alcantarilla, Murcia, Spain, 30820
3
Murcia University
Espinardo, Murcia, Spain, 30071
4
Valencia University
Valencia, Valencia, Spain, 46010