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Effects of Probiotics in Immune System of Healthy Adults (SETOPROB)

This study has been completed.
Sponsor:
Collaborators:
Universidad de Granada
University of Valencia
Universidad de Murcia
Information provided by (Responsible Party):
Pedro Abellan, Hero Institute for Infant Nutrition
ClinicalTrials.gov Identifier:
NCT01479543
First received: November 18, 2011
Last updated: September 4, 2014
Last verified: September 2014
Results First Received: August 19, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Condition: Conditions Influencing Health Status
Interventions: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group A

Volunteers are given strain CNCM I-4034.

Probiotic CNCM I-4034: 9x10E9 cfu (colony forming unit) per day during 28 days.

Group B

Volunteers receive Probiotic CNCM I-4035.

Probiotic CNCM I-4035: 9x10E9 cfu (colony forming unit) per day during 28 days.

Group C

Volunteers are given Probiotic CNCM I-4036.

Probiotic CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days.

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.

Group E

Volunteers receive a placebo.

Placebo capsule: Placebo capsule for 28 days.


Participant Flow:   Overall Study
    Group A     Group B     Group C     Group D     Group E  
STARTED     21     20     21     20     21  
COMPLETED     20     20     20     20     20  
NOT COMPLETED     1     0     1     0     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Group A

Volunteers are given strain CNCM I-4034.

Probiotic CNCM I-4034: 9x10E9 cfu (colony forming unit) per day during 28 days.

Group B

Volunteers receive Probiotic CNCM I-4035.

Probiotic CNCM I-4035: 9x10E9 cfu (colony forming unit) per day during 28 days.

Group C

Volunteers are given Probiotic CNCM I-4036.

Probiotic CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days.

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.

Group E

Volunteers receive a placebo.

Placebo capsule: Placebo capsule for 28 days.

Total Total of all reporting groups

Baseline Measures
    Group A     Group B     Group C     Group D     Group E     Total  
Number of Participants  
[units: participants]
  20     20     20     20     20     100  
Age  
[units: years]
Mean ± Standard Deviation
  28.7  ± 5     27  ± 5.7     29.4  ± 7.1     30.3  ± 7.6     28.5  ± 7.6     28.78  ± 1.22  
Age  
[units: participants]
           
<=18 years     0     0     0     0     0     0  
Between 18 and 65 years     20     20     20     20     20     100  
>=65 years     0     0     0     0     0     0  
Gender  
[units: participants]
           
Female     11     10     11     11     11     54  
Male     9     10     9     9     9     46  
Region of Enrollment  
[units: participants]
           
Spain     20     20     20     20     20     100  



  Outcome Measures

1.  Primary:   Gastrointestinal Tolerance After Probiotic Consumption.   [ Time Frame: 4 weeks of the treatments. Daily recorded. ]

2.  Secondary:   Gastrointestinal and Immune Effects of Probiotics Consumption.   [ Time Frame: At Time zero, after 4 weeks, and 2 later. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Esther Matencio Hilla
Organization: Hero Institute for Infant Nutrition
phone: +0034 968 89 89 00
e-mail: esther.matencio@hero.es


Publications:

Publications automatically indexed to this study:

Responsible Party: Pedro Abellan, Hero Institute for Infant Nutrition
ClinicalTrials.gov Identifier: NCT01479543     History of Changes
Other Study ID Numbers: SETOPROB
Study First Received: November 18, 2011
Results First Received: August 19, 2014
Last Updated: September 4, 2014
Health Authority: Spain: Ethics Committee