EndomicroscopyNCT01692613
Endomicroscopy, IBS and Food Intolerance
An observational study of Endomicroscopy and Inflammatory Bowel Syndrome, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
Background: The immediate endoscopic identification and diagnosis of intraepithelial structures and immediate and delayed reactions to allergens in the mucosal surface of the gut are unmet goals in the diagnosis and management of subjects with food intolerances, who are negative to all available tests. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Endomicroscopy, Inflammatory Bowel Syndrome, Food Intolerance
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2012to Sep 2014
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * N=50 patients with unexplained bloating and diarrhoea with suspicion of food intolerance and negative testing with routine methods * N=10 patients with Lactose intolerance * N=10 patients with Fructose intolerance * N=10 volunteers with Barrett's esophagus who need evaluation for possible dysplasia in the Barrett's mucosa with confocal endomicrosopy but no symptoms of bloating and abdominal pain (n=10) to serve as healthy controls for allergy testing
Who may be able to join
- age > 18 years
- ongoing abdominal symptoms such as bloating and abdominal pain
- negative routine testing for food intolerance (or known lactose/fructose intolerance)
- written informed consent
Who cannot join
- no consent
- known reason for the abdominal pain and bloating other than lactose/fructose intolerance
- M. Whipple
- known infectious gastrointestinal disease
- stricture in the upper gastrointestinal tract
- age >18years
Show all 12Show fewer
- impaired renal function (Creatinine >1.2 mg/dL)
- pregnancy or breast feeding
- inability to obtain informed consent
- active GI Bleeding
- known allergy to Methylene blue or Fluorescein
- participation in other clinical trials within the last 4 weeks
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Schleswig Holstein, Campus Kiel, Unit Experimental Endoscopy
Kiel, 24105
About this study
Official title: Confocal Endomicrosopy for the Detection of Food Intolerance in Patients With Irritable Bowel Syndrome
Background:
The immediate endoscopic identification and diagnosis of intraepithelial structures and immediate and delayed reactions to allergens in the mucosal surface of the gut are unmet goals in the diagnosis and management of subjects with food intolerances, who are negative to all available tests. Endomicroscopy may be helpful to further visualize and characterize unmasked small bowel reactions to foods, which has not been described before.
Read more
Confocal laser endomicroscopy provides confocal microscopic imaging simultaneously to the macroscopic view ,which enables the examiner to see immediate reactions after exposure and it further allows capturing of fluid excreted by the gut for further analysis to understand the pathology behind this reaction further.
N=50 patients with unexplained bloating and diarrhoea with suspicion of food intolerance and negative testing with routine methods. Patients with Lactose intolerance n=10 patients to compare results. Patients with Fructose intolerance n=10 patients to compare results. Volunteers with Barrett's esophagus who need evaluation for possible dysplasia in the Barrett's mucosa with confocal endomicrosopy but no symptoms of bloating and abdominal pain (n=10) to serve as healthy controls for allergy testing.
Methods:
The primary objective is to investigate whether endomicroscopy will allow the detection of an allergic reaction of the gut after exposure of the 5 major allergens in the following way:
After standard gastroscopy with the endomicroscope including evaluation of the surface of the upper gastrointestinal tract, i.v. injection of Fluorescein, then initial visualisation of the duodenal surface including count of initial lymphocytes/mononuclear cells in the lamina propria: Allergen 1 (milk), allergen 2 (wheat), allergen 3 (soya),allergen 4 (apple), allergen 5 (yeast).
The primary endpoint is the visible marked increase of lymphocytes and mononuclear cells in the lamina propria of the duodenum, representing an acute reaction to one of the allergens sprayed to its surface through the endoscope channel.
Read the detailed description
The primary endpoint is the visible marked increase of lymphocytes and mononuclear cells in the lamina propria of the duodenum, representing an acute reaction to one of the allergens sprayed to its surface through the endoscope channel.
- Medical subject headings
- Food Intolerance
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of mucosal reaction
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2014
- Study completionSep 2014
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 EndomicroscopyStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Collaborators
- Great Ormond Street Hospital for Children NHS Foundation Trust, Johannes Gutenberg University Mainz
- Responsible party
- Principal investigator, Mark Ellrichmann, University Hospital Schleswig-Holstein
- Investigators
- Annette Fritscher-Ravens, Prof. Dr., Principal investigator, University Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692613
- Sponsor's protocol ID
- A139/12
- Status last verified
- Jun 2015
- First submitted
- 20 Sep 2012
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fritscher-Ravens A, Schuppan D, Ellrichmann M, Schoch S, Rocken C, Brasch J, Bethge J, Bottner M, Klose J, Milla PJ. Confocal endomicroscopy shows food-associated changes in the intestinal mucosa of patients with irritable bowel syndrome. Gastroenterology. 2014 Nov;147(5):1012-20.e4. doi: 10.1053/j.gastro.2014.07.046. Epub 2014 Jul 30.
PubMed 25083606
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confocal Endomicrosopy for the Detection of Food Intolerance in Patients With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT01692613
- Acronym / sponsor ID
- A139/12
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Collaborators
- Great Ormond Street Hospital for Children NHS Foundation Trust, Johannes Gutenberg University Mainz
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 25 Sep 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.
Background:
The immediate endoscopic identification and diagnosis of intraepithelial structures and immediate and delayed reactions to allergens in the mucosal surface of the gut are unmet goals in the diagnosis and management of subjects with food intolerances, who are negative to all available tests. Endomicroscopy may be helpful to further visualize and characterize unmasked small bowel reactions to foods, which has not been described before.
Confocal laser endomicroscopy provides confocal microscopic imaging simultaneously to the macroscopic view ,which enables the examiner to see immediate reactions after exposure and it further allows capturing of fluid excreted by the gut for further analysis to understand the pathology behind this reaction further.
N=50 patients with unexplained bloating and diarrhoea with suspicion of food intolerance and negative testing with routine methods. Patients with Lactose intolerance n=10 patients to compare results. Patients with Fructose intolerance n=10 patients to compare results. Volunteers with Barrett's esophagus who need evaluation for possible dysplasia in the Barrett's mucosa with confocal endomicrosopy but no symptoms of bloating and abdominal pain (n=10) to serve as healthy controls for allergy testing.
Methods:
The primary objective is to investigate whether endomicroscopy will allow the detection of an allergic reaction of the gut after exposure of the 5 major allergens in the following way:
After standard gastroscopy with the endomicroscope including evaluation of the surface of the upper gastrointestinal tract, i.v. injection of Fluorescein, then initial visualisation of the duodenal surface including count of initial lymphocytes/mononuclear cells in the lamina propria: Allergen 1 (milk), allergen 2 (wheat), allergen 3 (soya),allergen 4 (apple), allergen 5 (yeast).
The primary endpoint is the visible marked increase of lymphocytes and mononuclear cells in the lamina propria of the duodenum, representing an acute reaction to one of the allergens sprayed to its surface through the endoscope channel.
Detailed description
The primary endpoint is the visible marked increase of lymphocytes and mononuclear cells in the lamina propria of the duodenum, representing an acute reaction to one of the allergens sprayed to its surface through the endoscope channel.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * N=50 patients with unexplained bloating and diarrhoea with suspicion of food intolerance and negative testing with routine methods * N=10 patients with Lactose intolerance * N=10 patients with Fructose intolerance * N=10 volunteers with Barrett's esophagus who need evaluation for possible dysplasia in the Barrett's mucosa with confocal endomicrosopy but no symptoms of bloating and abdominal pain (n=10) to serve as healthy controls for allergy testing
Key inclusion criteria (4 listed)
- age > 18 years
- ongoing abdominal symptoms such as bloating and abdominal pain
- negative routine testing for food intolerance (or known lactose/fructose intolerance)
- written informed consent
Key exclusion criteria (12 listed)
- no consent
- known reason for the abdominal pain and bloating other than lactose/fructose intolerance
- M. Whipple
- known infectious gastrointestinal disease
- stricture in the upper gastrointestinal tract
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of mucosal reaction
Time frame: immediate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
- Derived from this study: PubMed 25083606Fritscher-Ravens A, Schuppan D, Ellrichmann M, Schoch S, Rocken C, Brasch J, Bethge J, Bottner M, Klose J, Milla PJ. Confocal endomicroscopy shows food-associated changes in the intestinal mucosa of patients with irritable bowel syndrome. Gastroenterology. 2014 Nov;147(5):1012-20.e4. doi: 10.1053/j.gastro.2014.07.046. Epub 2014 Jul 30.
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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.
Annette Fritscher-Ravens, Prof. Dr. principal investigator
University Schleswig-Holstein
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 Endomicroscopy and Inflammatory Bowel Syndrome, run by University Hospital Schleswig-Holstein at 1 site in Germany.
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 4 inclusion and 12 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: finished, as of the sponsor's last update on 3 Jun 2015. 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 Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of mucosal reaction (time frame: immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01692613, 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 3 Jun 2015; AzTrials last refreshed its copy on 1 Nov 2026.