Status:
COMPLETED
Immune Evidence to the Consumption of Lactobacillus GG and FOS Consumption in Patients With Herpes Labialis
Lead Sponsor:
Sprim Advanced Life Sciences
Conditions:
Herpes Labialis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Herpes labialis (HL) is the result of the presence of a virus called HSV-1 and is a common disease. Because of its visibility due to cold sores it has a serious impact on social life. Until now there ...
Detailed Description
Background: Herpes labialis is the result of the presence of HSV-1 and is a common disease. Because of its visibility it has a serious impact on social life. Until now there is no effective treatment ...
Eligibility Criteria
Inclusion
- Healthy free-living men and women aged 18 to 65 years-old.
- History of recurrent HL (2 - 4 episodes) after exposure to sunlight in the previous 12 months.
- Fitzpatrick skin type 1 to 4 (appendix 1 of the study protocol).
- No presence of HL lesions at time of recruitment, including baseline.
- Agreement to adhere to the prescribed list of dietary recommendations provided at the start of the study (appendix 3 of the study protocol).
- Women of child-bearing potential are required to use adequate birth protection during the study.
- Sign and date the ICF to and to comply with study procedures
Exclusion
- Presence of acute/terminal disease.
- Intolerance for milk protein or lactose.
- Treatment with acyclovir or other medication believed to interfere with immune responses at the time of the study.
- Participation in any herpes UV reactivation study within the previous three months.
- Pregnancy or lactation.
- Any condition (e.g. schizophrenia, psychosis, major depression or mental deficiency) or major co-morbidity that the study investigator thinks might compromise the person's ability to comply with the requirements of the study.
Key Trial Info
Start Date :
September 14 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT03310294
Start Date
September 14 2010
End Date
August 1 2011
Last Update
October 16 2017
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