Biomarkers in Saliva and Stool

NCT03297008 | Terminated

• 1 other identifier: BIO-MK-001
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

To collect saliva and stool samples using the salimetrics swab and self-stool collection kit, process and store samples in a standardized manner. Following this, perform immunological assays such as enzyme-linked immunosorbent assay, multiplex bead assay and Immunocap to correlate the salivary and fecal levels of biomarkers in healthy donors. As this method is non-invasive, we believe that more people will be willing to donate samples.

Conditions

Healthy

Keywords

healthy; saliva; stool; biomarkers; Respiratory Syncytial Virus; Rotavirus; Immunoglobulin; Antibody

Outcome Measures

Primary Outcomes (2)

• Establish methods to detect immune markers in non-invasive samples: Saliva and stool in healthy volunteers

  ELISA RSV specific Immunoglobulin in saliva

  1 year after completion of recruitment

• Establish methods to detect immune markers in non-invasive samples: Saliva and stool in healthy volunteers

  ELISA Rotavirus specific Immunoglobulin in stool

  1 year after completion of recruitment

Secondary Outcomes (2)

• Difference in RSV-specific Immunoglobulins between age groups.

  1 year after completion of primary outcome

• Difference in RSV-specific Immunoglobulins between age groups.

  1 year after completion of primary outcome

Other Outcomes (2)

• Establish methods to detect immune markers in non-invasive samples: Saliva and stool in healthy volunteers

  1 year after completion of primary outcome

• Establish methods to detect immune markers in non-invasive samples: Saliva and stool in healthy volunteers

  1 year after completion of primary outcome

Interventions

No internvetion OTHER

No intervention, this is an observational study

Eligibility Criteria

• Age: Up to 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Volunteers in Singapore between 0 and 60 years of age

You may qualify if:

• Healthy volunteers of age 0-60 years old

You may not qualify if:

• Volunteers with any known infectious diseases, such as HIV and Hepatitis B
• Volunteers with any acute or chronic illness, such as chronic inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis)
• Volunteers with oral diseases/ulcers

Sponsors & Collaborators

• Danone Asia Pacific Holdings Pte, Ltd.: lead

Study Sites (1)

Danone Nutricia Research

Singapore, 138671, Singapore

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva, Stool samples

Study Officials

• Elena Sandalova, PhD

  Nutricia Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: September 29, 2017
• Study Start: March 11, 2015
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: March 12, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)