Irritable Bowel SyndromeNCT02316132
Confocal Laser Endomicroscopy, IBS and Stress
A study testing Stress in people with Irritable Bowel Syndrome, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
After standard endomicroscopy with fluorescein to investigate for dysplasia in Barrett's esophagus the endoscope will be forwarded into the 2nd part of the duodenum. Fluorescein is needed for CLE but is not part of the investigation. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Stress
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2014to Jul 2016
- Phase
- Interventional
- 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
Who may be able to join
- Age >18 years
- No abdominal symptoms such as bloating and abdominal pain
- Barrett's esophagus
- Independent indication for confocal laser endomicroscopy for evaluation of Barrett's dysplasia
- Written informed consent for participation in this study
Who cannot join
- Any known other gastrointestinal disease including infection such as helicobacter pylori, Morbus Whipple or others, celiac disease, or chronic inflammatory bowel disease
- Active or recent GI Bleeding
- Stricture in the upper gastrointestinal tract
- Impaired renal function (Creatinine >1.2 mg/dL)
- Pregnancy or breast feeding
- Inability to obtain informed consent
- 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
Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel
Kiel, 24105
About this study
Official title: Confocal Endomicroscopy for the Detection of Food Intolerances in Patients With IBS: Add on Control Group: Does Stress Cause Similar Mucosal Changes to Food Antigens?
After standard endomicroscopy with fluorescein to investigate for dysplasia in Barrett's esophagus the endoscope will be forwarded into the 2nd part of the duodenum. Fluorescein is needed for CLE but is not part of the investigation.
Initial CLE baseline images will be taken to assure intact mucosa and allow later detailed baseline counts of intraepithelial lymphocytes (IEL) and epithelial breaks in the duodenal mucosa.
Read more
Thereafter, either 10 ml NaCl 0.9% or 100µg CRF topped up to 10ml with NaCL 0.9% (according to randomisation) will be injected intravenously. Endoscopist and assistant staff will be blinded to the randomisation. Subsequently, the gut surface will be examined for at least 5 min with endomicroscopy for any change in IEL, epithelial breaks/gaps with extrusion of fluorescein into the gut lumen and widening of intervillous space.
Post procedure mucosal fluid will be aspirated for assessment of mast cell tryptase and eosin catatonic protein (ECP), and 8 duodenal biopsies will be taken for 1) electron microscopy to visualise mast cell degranulation and 2) paraffin embedding for subsequent staining for mast cell tryptase to identify mast cell activation and numbers.
The procedure will take around 15 minutes in addition to the routine investigation performed prior to the study. A study outline is presented in figure 1.
Samples taken are the same amount as done in the previous food associated study.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Stress, Control
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StressDrug
Also called CRH
Corticotropin-Releasing Hormone
ControlDrug
Also called Saline
Saline 0.9%
| Study group | Role | What they receive |
|---|---|---|
| Stress | Active comparator | Injection of corticotropin releasing factor Receives: Drug: Stress |
| Control | Placebo comparator | Injection of 0.9% saline 10 ml Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
visible marked increase of leaks/gaps with extrusion of fluorescein into the gut lumen.
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionJun 2016
- Study completionJul 2016
Why it stopped: No appropriate participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Ellrichmann, University Hospital Schleswig-Holstein
- Investigators
- Annette Fritscher-Ravens, MD, PhD, Principal investigator, University Hospital Schleswig-HolsteinMark Ellrichmann, MD, Principal investigator, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316132
- Sponsor's protocol ID
- IBS stress
- Status last verified
- Jun 2022
- First submitted
- 5 Dec 2014
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confocal Endomicroscopy for the Detection of Food Intolerances in Patients With IBS: Add on Control Group: Does Stress Cause Similar Mucosal Changes to Food Antigens?
- ClinicalTrials.gov ID
- NCT02316132
- Acronym / sponsor ID
- IBS stress
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No appropriate participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 12 Dec 2014 (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.
After standard endomicroscopy with fluorescein to investigate for dysplasia in Barrett's esophagus the endoscope will be forwarded into the 2nd part of the duodenum. Fluorescein is needed for CLE but is not part of the investigation.
Initial CLE baseline images will be taken to assure intact mucosa and allow later detailed baseline counts of intraepithelial lymphocytes (IEL) and epithelial breaks in the duodenal mucosa.
Thereafter, either 10 ml NaCl 0.9% or 100µg CRF topped up to 10ml with NaCL 0.9% (according to randomisation) will be injected intravenously. Endoscopist and assistant staff will be blinded to the randomisation. Subsequently, the gut surface will be examined for at least 5 min with endomicroscopy for any change in IEL, epithelial breaks/gaps with extrusion of fluorescein into the gut lumen and widening of intervillous space.
Post procedure mucosal fluid will be aspirated for assessment of mast cell tryptase and eosin catatonic protein (ECP), and 8 duodenal biopsies will be taken for 1) electron microscopy to visualise mast cell degranulation and 2) paraffin embedding for subsequent staining for mast cell tryptase to identify mast cell activation and numbers.
The procedure will take around 15 minutes in addition to the routine investigation performed prior to the study. A study outline is presented in figure 1.
Samples taken are the same amount as done in the previous food associated study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress | Active comparator | Drug: StressInjection of corticotropin releasing factor |
| Control | Placebo comparator | Drug: ControlInjection of 0.9% saline 10 ml |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >18 years
- No abdominal symptoms such as bloating and abdominal pain
- Barrett's esophagus
- Independent indication for confocal laser endomicroscopy for evaluation of Barrett's dysplasia
- Written informed consent for participation in this study
Key exclusion criteria (8 listed)
- Any known other gastrointestinal disease including infection such as helicobacter pylori, Morbus Whipple or others, celiac disease, or chronic inflammatory bowel disease
- Active or recent GI Bleeding
- Stricture in the upper gastrointestinal tract
- Impaired renal function (Creatinine >1.2 mg/dL)
- Pregnancy or breast feeding
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 |
|---|---|---|
| StressAlso: CRHCorticotropin-Releasing Hormone | Drug | Stress |
| ControlAlso: SalineSaline 0.9% | Drug | Control |
Primary outcome
visible marked increase of leaks/gaps with extrusion of fluorescein into the gut lumen.
Time frame: immediate
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
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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, MD, PhD principal investigator
University Hospital Schleswig-Holstein
Mark Ellrichmann, MD principal investigator
University Hospital Schleswig-Holstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress in people with Irritable 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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 6 Jul 2022. 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. Some participants in this study may receive a placebo. 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 withdrawn before enrolling participants, so there are no results.
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?
visible marked increase of leaks/gaps with extrusion of fluorescein into the gut lumen. (time frame: immediate). 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 6 Jul 2022.