Condition category
Not Applicable
Date applied
07/03/2016
Date assigned
30/03/2016
Last edited
29/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The immune system is a network of cells, tissues and organs which work to protect the body from infection. It takes time for the immune system to fully develop, and so children under five are more vulnerable to infections such as diarrhea and the common cold. Beta glucans are sugars found in bacteria, fungi and plants. For many years, they have been used to help boost the immune system in people whose natural defenses have been weakened due to disease or aggressive treatment, such as chemotherapy. It has been suggested that adding beta glucans to food could help to strengthen the immune system of young children. The aim of this study is to find out whether enriching yogurt with beta glucans from Ganoderma lucidum (a type of fungus) can help to strengthen the immune system of two to five year olds.

Who can participate?
Healthy children aged between two and five who are attached to the Childcare Foundation in Medellin Columbia).

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are given a normal yogurt to eat five days a week (Monday-Friday) for 12 weeks. Those in the second group are given a yogurt which contains added beta-glucan to eat five days a week (Monday-Friday) for 12 weeks. At the start of the study and then after 12 weeks, participants in both groups have a blood test, so that the levels of different immune cells can be measured in order to see whether their immune system is stronger.

What are the possible benefits and risks of participating?
There is a possibility that the participants that eat yogurts containing beta glucans could have a beneficial immune response. There are no notable risks involved with taking part in the study.

Where is the study run from?
Child Care Center, Lucila Jaramillo (Chile)

When is the study starting and how long is it expected to run for?
September 2015 to December 2015

Who is funding the study?
Colombian Institute for the Development of Science and Technology, Colciencias (Columbia)

Who is the main contact?
1. Dr Sergio Urrego (public)
2. Dr Edwin Higutia (scientific)
3. Dr Sandra Duque (scientific)
4. Dr Andrea Cano (scientific)

Trial website

Contact information

Type

Public

Primary contact

Dr Sergio Urrego

ORCID ID

http://orcid.org/0000-0003-0737-6249

Contact details

Progal-BT S.A.S
Calle 25 #65D 53
Medellín
050024074
Colombia

Type

Scientific

Additional contact

Dr Edwin Higuita

ORCID ID

http://orcid.org/0000-0001-5302-6042

Contact details

Uniremington
Facultad de Ciencias de la Salud
Calle 51 #51-27
Medellín
050010374
Colombia

Type

Scientific

Additional contact

Dr Sandra Duque

ORCID ID

http://orcid.org/0000-0002-3563-1529

Contact details

Universidad de Antioquia
Facultad de Enfermería
Calle 64 # 53 - 09
Medellín
050010480
Colombia

Type

Scientific

Additional contact

Dr Andrea Cano

ORCID ID

Contact details

Fedsalud
Carrera 43A #1S-100 Piso 20
Medellín
050022144
Colombia
+57 4 444 32 18
liderasistencial@fedsalud.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

Study hypothesis

Consuming yogurt enriched with beta-glucans for 12 weeks increases the T lymphocytes sub-populations and NK cells in 2 to 5 year old children.

Ethics approval

Ethics and Research Board of IPS Universitaria, University of Antioquia (Universidad de Antioquia), 26/08/2015, ref: 086

Study design

Phase II double-blind randomized placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Immune function

Intervention

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 weeks.

Beta-glucan group: Children consume a yogurt enriched with beta-glucans extracted biotechnologically from Ganoderma lucidum once daily, five days a week (Monday-Friday) for 12 weeks.

Participants in both groups provide blood samples at baseline and 12 weeks for immunomodulation assessments.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

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 outcome measures

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

Overall trial start date

04/09/2015

Overall trial end date

11/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

160

Participant 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

Recruitment start date

09/09/2015

Recruitment end date

11/09/2015

Locations

Countries of recruitment

Colombia

Trial participating centre

Child Care Center, Lucila Jaramillo
Fundación de Atención a la niñez. Calle 104 #50A-11
Medellín
050001009
Colombia

Sponsor information

Organisation

EAFIT University

Sponsor details

Carrera 49 # 7 sur -50
Medellín
050022009
Colombia
+57 4 2619500 Ext 9643
contacto@eafit.edu.co

Sponsor type

University/education

Website

http://www.eafit.edu.co/

Organisation

Progal-BT S.A.S

Sponsor details

Calle 25 #65D 53
Medellín
050024074
Colombia
+57 4 4442068
progalbt@progal-bt.com

Sponsor type

Industry

Website

http://www.progal-bt.com/

Organisation

Colanta

Sponsor details

Calle 74 #64 A-51
Medellín
050034112
Colombia
+57 4 4455555
contacto@colanta.com.co

Sponsor type

Industry

Website

www.colanta.com.co

Funders

Funder type

Research organisation

Funder name

Colombian Institute for the Development of Science and Technology (Colciencias)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of results in a peer reviewed journal.

Intention to publish date

01/07/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes