Evaluation of Biomodulin T sublingual Vs intramuscular in the elderly.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000194

Enrollment

Registered

2015-04-13

Start date

2015-04-30

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent respiratory diseases

Interventions

Group I (Experimental): 3 mg daily Biomodulina T be administered sublingually (divided by 2 times daily) for 25 days Group II (Control): 3 mg daily Biomodulina T be administered intramuscularly (1 tim

Eligibility

Sex/Gender

All

Age

60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Background of viral infections and / or recurrent bacterial (more than 2) during the last twelve months. 2. Reduction of some parameters of Cellular Immunity (populations of T and B lymphocytes, subpopulations CD4, CD8 or cytokines, and / or populations of immune complexes). 3. Altered skin tests. 4. People over 60 years of age, of both sexes regardless of skin color. 5. Willingness to participate in the trial.

Exclusion criteria

Exclusion criteria: 1. Patients with collagen diseases. 2. Liver chronic carriers. 3. Carriers Tuberculosis and Hansen. 4. Carriers of diagnosed malignancies. 5. Patients who have previously received some form of treatment effects on the immune system, whether modulators or suppressors in the previous six months. 6. Patients in convalescence period (up to two weeks) of an acute infectious disease that could alter the immune response. 7. Patients with diseases that alter gastrointestinal drug absorption.

Design outcomes

Primary

Measure	Time frame
Immunologic: Subpopulations CD3, CD4, CD8 and CD19 (by flow cytometry). Measurement time: every 2 months after the first administration and up to 6 months after treatment.	—

Secondary

Measure	Time frame
- Clinics Influenza (yes/no). Measurement time: every 2 months after the first administration and up to 6 months after treatment. Bronchopneumonia (yes/no). Measurement time: every 2 months after the first administration and up to 6 months after treatment. Number of Income (yes/no, if yes, how many in one year). Measurement time: every 2 months after the first administration and up to 6 months after treatment. - Adverse events (AEs). Measurement time: every 2 months after the first administration and up to 6 months after treatment. It is measured as follows: Occurrence of an EA in the patient (yes / no). Description EA (Name of adverse event). According to the preliminary information available (unexpected and expected) According to the intensity of EA (Mild, Moderate) Severity EA (Grave / serious, not serious / not serious) Attitude regarding the treatment under study (unchanged, temporary interruption or definitive treatment under study) Outcome of EA (recovered, improved persists or sequels) Causality relationship (1. Very Likely, 2.Probable, 3.Posible, 4.Improbable, 5.No related, 6.No evaluable)	—

Measure

Time frame

- Clinics Influenza (yes/no). Measurement time: every 2 months after the first administration and up to 6 months after treatment. Bronchopneumonia (yes/no). Measurement time: every 2 months after the first administration and up to 6 months after treatment. Number of Income (yes/no, if yes, how many in one year). Measurement time: every 2 months after the first administration and up to 6 months after treatment. - Adverse events (AEs). Measurement time: every 2 months after the first administration and up to 6 months after treatment. It is measured as follows: Occurrence of an EA in the patient (yes / no). Description EA (Name of adverse event). According to the preliminary information available (unexpected and expected) According to the intensity of EA (Mild, Moderate) Severity EA (Grave / serious, not serious / not serious) Attitude regarding the treatment under study (unchanged, temporary interruption or definitive treatment under study) Outcome of EA (recovered, improved persists or sequels) Causality relationship (1. Very Likely, 2.Probable, 3.Posible, 4.Improbable, 5.No related, 6.No evaluable)

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Countries

Cuba

Contacts

Public ContactBarbara Leyva Salermo

Longevity Research Center, Aging and Health. CITED

babyl@infomed.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026