Ozone-Therapy-Immunoglobulin A deficiency-adults and childrens-Phase II

Systemic ozone therapy by means rectal insuflaction applied of the patiens with inmunoglobulin A deficency. (OTIGAD-2) - OTIGAD-2

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000236

Enrollment

Unknown

Registered

2017-02-16

Start date

2010-01-18

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Immunoglobulin A Deficiency

Interventions

Group 1 (experimental): Ozone Therapy + Covencional treatment ( antibiotics if infectious illnesses bacterial + especific meidication to control illnnesses associated to IgAD) . the ozone therapy is a

Ozone

Complementary Therapies

Transfer Factor

Anti-Bacterial Agents

Insufflation

Administration, Rectal

Injections, Subcutaneous

Hebertrans, Ozonotherapy

Eligibility

Sex/Gender

All

Age

4 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1- IgA deficiency complete or partial, selective IgA deficiency or with deficient specific antibody response, IgAD isolated or associated to allergic , autoimmune and neoplasic illness. 2- Informed Consent of the parents for the participation of childrens in the study or Signed informed consent of the adults .

Exclusion criteria

Exclusion criteria: 1- Having received blood transfusions three previous months or during the study 2- Having recived immunomodulator treatment 6 previous months to study. 3- Any specific conditions that advise against any one of the treatments.

Design outcomes

Primary

Measure	Time frame
Objective Response (Complete response, Partial response, Stable disease, Progressive disease). Measurement time: 2, 4 and 6 months.	—

Secondary

Measure	Time frame
Immunoglobulin's levels-IgA, IgG, IgM (Normal, Enlarged, Diminished). Measurement time: at baseline, 4 and 6 months. Clinical State (Satisfactory, Acceptable, Equal). Measurement time: at baseline, 4 and 6 months. Oxidative-damage scoreboards (Normal, Enlarged, Diminished). Measurement time: at baseline and, 6 months. Antirust- defense scoreboards: at baseline and, 6 months. Adverse Events-AE (Occurrence of AE (Yes, No), Description of AE (name of the adverse event), Intensity of AE (Light, Moderated, Severe)). Measurement time: 2, 4 and 6 months. Illnesses associated (Occurrence of illnesses associated (Yes, No), Description of illness (Allergic, Autoimmune, Infectious)). Measurement time: at baseline.	—

Measure

Time frame

Immunoglobulin's levels-IgA, IgG, IgM (Normal, Enlarged, Diminished). Measurement time: at baseline, 4 and 6 months. Clinical State (Satisfactory, Acceptable, Equal). Measurement time: at baseline, 4 and 6 months. Oxidative-damage scoreboards (Normal, Enlarged, Diminished). Measurement time: at baseline and, 6 months. Antirust- defense scoreboards: at baseline and, 6 months. Adverse Events-AE (Occurrence of AE (Yes, No), Description of AE (name of the adverse event), Intensity of AE (Light, Moderated, Severe)). Measurement time: 2, 4 and 6 months. Illnesses associated (Occurrence of illnesses associated (Yes, No), Description of illness (Allergic, Autoimmune, Infectious)). Measurement time: at baseline.

—

Countries

Cuba

Contacts

Public ContactJacqueline Diaz luis

Roberto Rodriguez Fernandez general hospital

jdiaz@hgm.cav.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Apr 4, 2026