Inflammatory Bowel DiseasesNCT01590043
Identifying Saliva Markers in Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Under normal conditions intestinal mucosa presents a baseline "physiological inflammation" caused by a controlled immune response that eliminates offending dietary and microbial antigens. This inflammation disappears once the cause is eradicated. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Salivary samples
- How many people
- 160 participants
- Where
- 1 siteIsrael
- Study dates
- May 2012to May 2013
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients identified with infalmmatory bowel disease
Who may be able to join
- Identified with inflammatory bowel disease
Who cannot join
- medically compromised children
- congenital syndromes
- children on medication chronically or on the day of the examination
- children treated with radiotherapy or chemotherapy.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization
Jerusalem
Hadas Lemberg, PhD, 0097226777572, lhadas@hadassah.org.il
Moti Moskovich
About this study
Under normal conditions intestinal mucosa presents a baseline "physiological inflammation" caused by a controlled immune response that eliminates offending dietary and microbial antigens. This inflammation disappears once the cause is eradicated. In case of inappropriate immunological response, the inflammation becomes chronic and harmful, resulting in anatomical and functional abnormalities, namely inflammatory bowel disease (IBD).
Although it is critical for the IBD patients to undergo early diagnosis and management before the development of severe complications, but as IBD has vague and non-pathognomonic clinical features, the clinician is usually mislead into late suspicion and detection of IBD.
Read more
Diagnosis traditionally depended on a combination of pathologic evaluation together with the histological, clinical, radiological, endoscopic, surgical, laboratory (serological) features. Recently, serological markers were identified and became of special interest as they do not only detect the occurrence of IBD but also the potential of its development and may be used as prognostic tools. More recently, stool markers were detected and used for diagnosis.
Up to now, the market is still lacking a definitive, simple and non-invasive diagnostic tool. Saliva can present an alternative form of body fluids that simplify diagnostic procedures.
Our hypothesis is that IBD patients have special salivary biomarkers that may be identified through salivary analysis, where later on a simple non-invasive test can be applied in the form of an easy-to-use kit, being available at the clinician's clinic for the establishment of an immediate and early diagnosis of the destructive inflammatory bowel disease.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Salivary samples
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salivary samplesOther
Also called Salivary Analysis
Each participant will give a sample of saliva through spitting for 5 minutes in a sterile tube.
| Study group | Role | What they receive |
|---|---|---|
| Control | Healthy 3-18 years old participants Receives: Other: Salivary samples | |
| Inflammatory bowel disease | 3-18 years old patients identified with inflammatory bowel disease Receives: Other: Salivary samples | |
| Abdominal pain | 3-18 years old patients suffering from abdominal pain not related to Inflammatory bowel disease Receives: Other: Salivary samples |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moti Moskovitz, DMD, PhD, Principal investigator, Hadassah Medical OrganizationEyal Shteyer, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590043
- Sponsor's protocol ID
- LSA002-HMO-CTIL
- Status last verified
- Jul 2012
- First submitted
- 30 Apr 2012
- Last updated
- 7 Sep 2012
- Results posted
- No
Publications
Palmon R, Brown SJ, Abreu MT. What is the role and significance of serum and stool biomarkers in the diagnosis of IBD? Inflamm Bowel Dis. 2008 Oct;14 Suppl 2:S187-9. doi: 10.1002/ibd.20714.
PubMed 18816678
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Saliva Markers in Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT01590043
- Acronym / sponsor ID
- LSA002-HMO-CTIL
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- May 2013 (estimated)
- First posted
- 2 May 2012 (estimated)
- 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.
Under normal conditions intestinal mucosa presents a baseline "physiological inflammation" caused by a controlled immune response that eliminates offending dietary and microbial antigens. This inflammation disappears once the cause is eradicated. In case of inappropriate immunological response, the inflammation becomes chronic and harmful, resulting in anatomical and functional abnormalities, namely inflammatory bowel disease (IBD).
Although it is critical for the IBD patients to undergo early diagnosis and management before the development of severe complications, but as IBD has vague and non-pathognomonic clinical features, the clinician is usually mislead into late suspicion and detection of IBD.
Diagnosis traditionally depended on a combination of pathologic evaluation together with the histological, clinical, radiological, endoscopic, surgical, laboratory (serological) features. Recently, serological markers were identified and became of special interest as they do not only detect the occurrence of IBD but also the potential of its development and may be used as prognostic tools. More recently, stool markers were detected and used for diagnosis.
Up to now, the market is still lacking a definitive, simple and non-invasive diagnostic tool. Saliva can present an alternative form of body fluids that simplify diagnostic procedures.
Our hypothesis is that IBD patients have special salivary biomarkers that may be identified through salivary analysis, where later on a simple non-invasive test can be applied in the form of an easy-to-use kit, being available at the clinician's clinic for the establishment of an immediate and early diagnosis of the destructive inflammatory bowel disease.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: Salivary samplesHealthy 3-18 years old participants |
| Inflammatory bowel disease | – | Other: Salivary samples3-18 years old patients identified with inflammatory bowel disease |
| Abdominal pain | – | Other: Salivary samples3-18 years old patients suffering from abdominal pain not related to Inflammatory bowel disease |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients identified with infalmmatory bowel disease
Key inclusion criteria (1 listed)
- Identified with inflammatory bowel disease
Key exclusion criteria (4 listed)
- medically compromised children
- congenital syndromes
- children on medication chronically or on the day of the examination
- children treated with radiotherapy or chemotherapy.
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 |
|---|---|---|
| Salivary samplesAlso: Salivary AnalysisEach participant will give a sample of saliva through spitting for 5 minutes in a sterile tube. | Other | Abdominal pain, Control, Inflammatory bowel disease |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2012.
- Background: PubMed 18816678Palmon R, Brown SJ, Abreu MT. What is the role and significance of serum and stool biomarkers in the diagnosis of IBD? Inflamm Bowel Dis. 2008 Oct;14 Suppl 2:S187-9. doi: 10.1002/ibd.20714.
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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.
Moti Moskovitz, DMD, PhD principal investigator
Hadassah Medical Organization
Eyal Shteyer, MD principal investigator
Hadassah Medical Organization
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 Inflammatory Bowel Diseases, run by Hadassah Medical Organization at 1 site in Israel.
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 4 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: status not confirmed, as of the sponsor's last update on 7 Sep 2012. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01590043, which also lists 1 linked publication.
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 7 Sep 2012.