Evaluation of the immune system in children aged 2 to 5 that receive yogurt enriched with beta glucans extracted from the fungus Ganoderma lucidum

Evaluation of changes on CD4+, CD8 T cells and NK, cells in children aged 2 to 5 during a 12 week intervention with a yogurt enriched with Ganoderma lucidum beta-glucans obtained biotechnologically: A double-blind ramdomized placebo controlled phase II trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN64202426

Enrollment

160

Registered

2016-03-30

Start date

2015-09-09

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Immune function Not Applicable Immune function

Interventions

Participants are randomly allocated to either intervention groups (Placebo or beta-glucans). Placebo group: Children consume a standard yogurt once daily, five days a week (Monday-Friday) for 12 wee

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Children aged 2-5 2. Children attached to the Childcare Foundation - Medellin (Fundación de Atención a la Niñez (FAN) - Medellin)

Exclusion criteria

Exclusion criteria: 1. Children whose parents refuse to sign and accept the informed consent 2. Children outside of the General and Social Health Care System of Colombia 3. Use of corticosteroids or any other medical or pharmaceutical intervention 4. Diabetes

Design outcomes

Primary

Measure	Time frame
1. CD4+ and CD8+ T lymphocytes counts are measured using flow cytometry from blood samples at baseline and 12 weeks 2. NK cell counts are measured using flow cytometry (CD16+/CD56+) from blood samples at baseline and 12 weeks	—

Secondary

Measure	Time frame
1. Hemoleucogram is measured using flow cytometry at baseline and 12 weeks 2. Serum IgA is measured by immunoturbidimetry at baseline and 12 weeks 3. Nutritional and anthropometric measurements evaluated according to WHO guidelines and using WHO AnthroPlus software at baseline and 12 weeks 3.1. Weight/Height index 3.2. Height/Age index 3.3. Weight/Age index 4. Th1/Th2 citokines profile in serum is measured using Cytometric Bead Array (CBA) at baseline and 12 weeks	—

Measure

Time frame

1. Hemoleucogram is measured using flow cytometry at baseline and 12 weeks 2. Serum IgA is measured by immunoturbidimetry at baseline and 12 weeks 3. Nutritional and anthropometric measurements evaluated according to WHO guidelines and using WHO AnthroPlus software at baseline and 12 weeks 3.1. Weight/Height index 3.2. Height/Age index 3.3. Weight/Age index 4. Th1/Th2 citokines profile in serum is measured using Cytometric Bead Array (CBA) at baseline and 12 weeks

—

Countries

Colombia

Contacts

Public ContactSergio Urrego

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026