HealthyNCT03297008
Biomarkers in Saliva and Stool
An observational study of Healthy, run by Danone Asia Pacific Holdings Pte, Ltd. at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- No internvetion
- How many people
- 86 participants
- Where
- 1 siteSingapore
- Study dates
- 11 Mar 2015to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Healthy Volunteers in Singapore between 0 and 60 years of age
Who may be able to join
- Healthy volunteers of age 0-60 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Understanding Innate and Adaptive Immunological Response in Stool and Saliva Samples in Healthy Donors
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.
Read the detailed description
Many soluble factors found in blood can be detected in saliva and stool. Often levels of these factors are found to correlate between body fluids, though the exact relationship between systemic (blood) and local (saliva and stool) immunity is not well established yet. Saliva- and stool-associated factors are produced in the oral cavity and in the gut, which represent mucosal sites that potentially come in direct contact with pathogens. Thus, the levels of mucosal-associated soluble factors can better represent the local immune response at these sites.
It is becoming clear now that saliva and stool can be used to analyze inflammatory responses as well. In a recent study, 20 possible salivary biomarkers related to obesity were surveyed and the authors found four biomarkers that exhibit significant change with increasing body weight in a pediatric population. Salivary C-reactive protein (CRP), salivary insulin, leptin and adiponectin were found to be different in obese children compared to healthy normal weight children. This data suggests that saliva could be a useful blood surrogate for the study of metabolic complications of obesity in children, where repeated blood sampling can be both traumatic and difficult. The results of this study also provide insight into the early development of metabolic disease in children. (Goodson, Kantarci et al. 2014). In another study, cytokines-chemokines-growth factors (CCGFs) were measured using multiplex bead assays and compared between plasma, saliva and urine collected from 20 male and female healthy volunteers. By analyzing more than one sample types from the same subject would increase the possibility of identifying biomarker(s) for any inflammatory disease. In this study, gender-specific CCGFs were also observed and concentrations of some CCGFs varied between genders. This information is also valuable for biomarker discovery that by combining male and female subjects in a clinical trial would eliminate false discovery of biomarkers (Khan 2012).
The mucosal immune system can be also understood by analyzing stool samples. In a recent study, it is shown that a particular bacterial predominance, such as Bifidobacterium sp., may enhance thymic development and immune responses to both oral and parenteral vaccines early in infancy, whereas a deviation from this pattern, resulting in greater bacterial diversity, may cause systemic inflammation (neutrophilia) and lower vaccine responses. Thus, vaccine responsiveness may be improved by promoting intestinal Bifidobacteria sp. and minimizing dysbiosis early in infancy (Huda, Lewis et al. 2014). Of note, the hallmark of adequate mucosal immune responses is the production of secretory immunoglobulin A (SIgA), which can prevent infection and remove antigen crossing the mucosal barrier.SIgAis also imperative to establish mutualism between host and the intestinal microbiota (Maynard, Elson et al. 2012). Hence measurement of SIgA can help to assess the mucosal immunity.
Despite saliva and stool samples are increasingly studied in order to assess mucosal immune response and/or clinical outcomes, there is still a lack of established methodology to be routinely used in diagnostic laboratories and clinical trials. Therefore our aim is to collect saliva and stool samples using the salimetrics swab and self-stool collection kit from a cohort of 60 volunteers, process and store samples in a standardized manner. Following this, we intend to 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. It is also easy to self-collect and it is cost efficient.
- Conditions
- Healthy
- Being tested
- No internvetion
- Keywords
- healthy, saliva, stool, biomarkers, Respiratory Syncytial Virus, Rotavirus, Immunoglobulin, Antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No internvetionOther
No intervention, this is an observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish methods to detect immune markers in non-invasive samples: Saliva and stool in healthy volunteers
ELISA RSV specific Immunoglobulin in saliva
Measured: 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
Measured: 1 year after completion of recruitment
Secondary outcomes (2)
Difference in RSV-specific Immunoglobulins between age groups.
Correlation between age and RSV-specific Immunoglobulins in saliva
Measured: 1 year after completion of primary outcome
Difference in RSV-specific Immunoglobulins between age groups.
Correlation between age and rotavirus-specific Immunoglobulins in stool
Measured: 1 year after completion of primary outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start11 Mar 2015
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elena Sandalova, PhD, Principal investigator, Nutricia Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297008
- Sponsor's protocol ID
- BIO-MK-001
- Status last verified
- Dec 2017
- First submitted
- 26 Sep 2017
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IDP is not going to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Innate and Adaptive Immunological Response in Stool and Saliva Samples in Healthy Donors
- ClinicalTrials.gov ID
- NCT03297008
- Acronym / sponsor ID
- BIO-MK-001
- Conditions
- Healthy
- Keywords
- healthy, saliva, stool, biomarkers, Respiratory Syncytial Virus, Rotavirus, Immunoglobulin, Antibody
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Mar 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 29 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Many soluble factors found in blood can be detected in saliva and stool. Often levels of these factors are found to correlate between body fluids, though the exact relationship between systemic (blood) and local (saliva and stool) immunity is not well established yet. Saliva- and stool-associated factors are produced in the oral cavity and in the gut, which represent mucosal sites that potentially come in direct contact with pathogens. Thus, the levels of mucosal-associated soluble factors can better represent the local immune response at these sites.
It is becoming clear now that saliva and stool can be used to analyze inflammatory responses as well. In a recent study, 20 possible salivary biomarkers related to obesity were surveyed and the authors found four biomarkers that exhibit significant change with increasing body weight in a pediatric population. Salivary C-reactive protein (CRP), salivary insulin, leptin and adiponectin were found to be different in obese children compared to healthy normal weight children. This data suggests that saliva could be a useful blood surrogate for the study of metabolic complications of obesity in children, where repeated blood sampling can be both traumatic and difficult. The results of this study also provide insight into the early development of metabolic disease in children. (Goodson, Kantarci et al. 2014). In another study, cytokines-chemokines-growth factors (CCGFs) were measured using multiplex bead assays and compared between plasma, saliva and urine collected from 20 male and female healthy volunteers. By analyzing more than one sample types from the same subject would increase the possibility of identifying biomarker(s) for any inflammatory disease. In this study, gender-specific CCGFs were also observed and concentrations of some CCGFs varied between genders. This information is also valuable for biomarker discovery that by combining male and female subjects in a clinical trial would eliminate false discovery of biomarkers (Khan 2012).
The mucosal immune system can be also understood by analyzing stool samples. In a recent study, it is shown that a particular bacterial predominance, such as Bifidobacterium sp., may enhance thymic development and immune responses to both oral and parenteral vaccines early in infancy, whereas a deviation from this pattern, resulting in greater bacterial diversity, may cause systemic inflammation (neutrophilia) and lower vaccine responses. Thus, vaccine responsiveness may be improved by promoting intestinal Bifidobacteria sp. and minimizing dysbiosis early in infancy (Huda, Lewis et al. 2014). Of note, the hallmark of adequate mucosal immune responses is the production of secretory immunoglobulin A (SIgA), which can prevent infection and remove antigen crossing the mucosal barrier.SIgAis also imperative to establish mutualism between host and the intestinal microbiota (Maynard, Elson et al. 2012). Hence measurement of SIgA can help to assess the mucosal immunity.
Despite saliva and stool samples are increasingly studied in order to assess mucosal immune response and/or clinical outcomes, there is still a lack of established methodology to be routinely used in diagnostic laboratories and clinical trials. Therefore our aim is to collect saliva and stool samples using the salimetrics swab and self-stool collection kit from a cohort of 60 volunteers, process and store samples in a standardized manner. Following this, we intend to 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. It is also easy to self-collect and it is cost efficient.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Healthy Volunteers in Singapore between 0 and 60 years of age
Key inclusion criteria (1 listed)
- Healthy volunteers of age 0-60 years old
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No internvetionNo intervention, this is an observational study | Other | – |
Primary outcome
Establish methods to detect immune markers in non-invasive samples: Saliva and stool in healthy volunteers
Time frame: 1 year after completion of recruitment
ELISA RSV specific Immunoglobulin in saliva
Establish methods to detect immune markers in non-invasive samples: Saliva and stool in healthy volunteers
Time frame: 1 year after completion of recruitment
ELISA Rotavirus specific Immunoglobulin in stool
2 secondary outcomes
Difference in RSV-specific Immunoglobulins between age groups.
Time frame: 1 year after completion of primary outcome
Difference in RSV-specific Immunoglobulins between age groups.
Time frame: 1 year after completion of primary outcome
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
- Individual participant dataSharing planned: No. IDP is not going to be shared.
Related trials for Healthy
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Sandalova, PhD principal investigator
Nutricia Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Danone Asia Pacific Holdings Pte, Ltd. at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish methods to detect immune markers in non-invasive samples: Saliva and stool in healthy volunteers (time frame: 1 year after completion of recruitment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2018.