Tuberculosis Clinical Trial
Official title:
Pilot Clinical Trial, Double-blind, Randomized, Placebo Controlled and Masked to Evaluate the Tolerability and Immunogenicity of Nyaditum Resae® Probiotic Administered to Adults With or Without Latent Tuberculosis Infection
NCT number | NCT02076139 |
Other study ID # | NYADATREG |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2014 |
Est. completion date | July 2015 |
Verified date | September 2017 |
Source | Manresana de Micobacteriologia, SL |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a double-blind, masked, compared with placebo clinical trial in healthy volunteers with or without tuberculosis infection. This trial aims to study the effect of the probiotic Nyaditum resae® at the level of specific Regulatory T cells (Treg) memory cells one week after the first administration and the global tolerability of the treatment. Nyaditum resae® is a preparation in the form of drinkable vials containing heat-killed environmental mycobacteria. The overall objective of the study is the effect of Nyaditum resae® on immunity, which could reduce the risk of developing active tuberculosis.
Status | Completed |
Enrollment | 47 |
Est. completion date | July 2015 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: 1. Informed consent before starting the selection process. 2. Women and men = 18 years. 3. Availability to meet the requirements of the protocol. Exclusion Criteria: 1. HIV positive. 2. Known immunodeficiencies. 3. Pregnancy and maternal lactation. 4. Active tuberculosis. 5. Enrollment in another clinical trial. 6. Chronic administration of: methotrexate, azathioprine, cyclophosphamide, oral corticosteroids and other immunosuppressive therapies / immunomodulatory . 7. Administration of blood products or blood derivatives during the 6 months prior to randomization. 8. Detection by the researcher lack of knowledge or willingness to participate and fulfill all the requirements of the protocol. 9. Any other finding that the investigator's opinion, could jeopardize the performance of the protocol or significantly influence the results or interpretation of the effects of probiotic. |
Country | Name | City | State |
---|---|---|---|
Spain | Germans Trias I Pujol Hospital | Badalona | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Manresana de Micobacteriologia, SL |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in Specific Treg memory cells at week 1 | Median increase of specific Treg memory cells at week 1. | From Baseline to Week 1 | |
Primary | Global tolerability of Nyaditum resae ®, proportion of participants with adverse events related to study treatment. | Proportion of patients presenting adverse events related to study treatment. | Baseline to week 6 | |
Secondary | Local tolerability (gastrointestinal duct), proportion of participants with gastrointestinal adverse events related to study treatment. | Proportion of participants presenting gastrointestinal adverse events related to study treatment. | Baseline to week 6 | |
Secondary | Systemic tolerability (vital signs, physical exam, laboratory tests), proportion of participants with systemic adverse events related to study treatment. | Proportion of participants presenting systemic adverse events related to study treatment. | Baseline to week 6 | |
Secondary | Change from Baseline in Specific Treg memory cells at week 2 | Median increase of specific Treg memory cells at week 2. | From Baseline to Week 2 | |
Secondary | Change from Baseline in Specific Treg memory cells at month 12 | Median increase of specific Treg memory cells at month 12 | From Baseline to Month 12 |
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