Functional DyspepsiaNCT03296267
Influence of Bile Acids on Bacterial Uptake in Functional Dyspepsia
A study testing Gastroduodenoscopy in people with Functional Dyspepsia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
In up to half of patients seen by gastroenterologists, routine examinations fail to find an underlying organic, systemic, or metabolic disease that readily explains the symptoms. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Gastroduodenoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Jan 2017to 27 Aug 2018
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Three days before the measurement: no smoking and drinking alcohol
- 12 hours before the measurement: no drinking and eating
Who cannot join
- symptoms or history of gastrointestinal disease
- first degree relatives with celiac disease
- diabetes mellitus
- allergy/atopy (eczema, asthma, allergic rhinoconjunctivitis)
- coagulation disorders/anticoagulant therapy
- first degree relatives with Crohn's disease or type I diabetes mellitus.
- intake of antihistamines, ketotifen, cromoglycate, acetylsalicylates, NSAIDs, anticholinergics, theophylline, β2-agonists, codeine or opioid derivatives for at least 2 weeks prior to the gastroscopy
- Intake of steroid or immunosuppressive drugs in the last 6 months
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Translational Research center for Gastrointestinal Disorders (TARGID)
Leuven, Vlaams-Brabant, 3000
About this study
Official title: Translocation of Microorganisms in Duodenal Biopsies of Healthy Volunteers and Patients With Functional Dyspepsia
In up to half of patients seen by gastroenterologists, routine examinations fail to find an underlying organic, systemic, or metabolic disease that readily explains the symptoms. These patients are referred to as patients with disorders of gastrointestinal function, of which functional dyspepsia (FD) is one of the most common. Despite intensive research to investigate various pathophysiological mechanisms of this disease, the pathogenesis remains obscure. The investigators recently demonstrated increased duodenal permeability in FD patients, as assessed by mounting routine endoscopic duodenal biopsy specimens into Ussing chambers to measure transepithelial electrical resistance and passage of a paracellular fluorescent probe. Impaired intestinal barrier function can lead to increased uptake of luminal substances which can induce an immunological response in the mucosa. Interestingly, using transmission electron microscopy (TEM) in duodenal biopsies, the investigators recently observed the presence of a yet to be identified microorganism inside the epithelium and the lamina propria of a subset of FD patients (unpublished observations), suggesting increased translocation of microorganisms.
The aim of the project is to investigate whether FD patients display increased translocation of microorganisms in duodenal biopsies. The investigators will also test the effect of bile acid on translocation of microorganisms and therefore include 20 FD patients and 20 age- and gender-matched healthy volunteers in this study.
Read the detailed description
The participants will be expected on the department endoscopy of the University Hospital Gasthuisberg, Leuven, Belgium. They are asked to fill in a bundle of questionnaires concerning physical complaints, depression, anxiety (disturbances), pain/disease, body/interoceptive awareness, trauma/abuse and personality. Endoscopy will be performed and up to 8 biopsies will be obtained from the duodenum. All endoscopies will be performed by an experienced endoscopist. Biopsies will be mounted in Ussing chambers and the mucosal compartment will be exposed to commercially available fluorescein-conjugated microorganisms. Uptake of microorganisms will be evaluated by analyzing the serosal compartment and by confocal microscopy of the biopsies. These experiments will also be performed in combination with exposure to bile acids separately and jointly, to assess if bacterial translocation can be exacerbated by these endogenous luminal factors individually and synergistically.
- Conditions
- Functional Dyspepsia
- Being tested
- Gastroduodenoscopy
- Keywords
- bile acid, bacterial uptake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GastroduodenoscopyProcedure or surgery
Gastroduodenoscopy with duodenal biospies: A tube is placed via the mouth into the second part of the duodenum. Biopsy forceps is used to take duodenal biopsies.
| Study group | Role | What they receive |
|---|---|---|
| gastroduodenoscopy | Other | all participants undergo a gastroduodenoscopy to use the biopsies in an Ussing chamber experiment. Receives: Procedure: Gastroduodenoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial uptake in the duodenal biopsy measured by fluorescent intensity at the basolateral side of the ussing chamber setup.
duodenal uptake of fluorescein conjugated microorganisms
Measured: 120 minutes
Secondary outcomes (1)
duodenal permeability assessed by measuring transepithelial electrical resistance in the Ussing chamber setup
transepithelial electrical resistance
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start2 Jan 2017
- Primary completion27 Apr 2018
- Study completion27 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Tack, Professor, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296267
- Sponsor's protocol ID
- s56880
- Status last verified
- Jul 2024
- First submitted
- 18 Sep 2017
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translocation of Microorganisms in Duodenal Biopsies of Healthy Volunteers and Patients With Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT03296267
- Acronym / sponsor ID
- s56880
- Conditions
- Functional Dyspepsia
- Keywords
- bile acid, bacterial uptake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 27 Apr 2018 (actual)
- Study completion
- 27 Aug 2018 (actual)
- First posted
- 28 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.
In up to half of patients seen by gastroenterologists, routine examinations fail to find an underlying organic, systemic, or metabolic disease that readily explains the symptoms. These patients are referred to as patients with disorders of gastrointestinal function, of which functional dyspepsia (FD) is one of the most common. Despite intensive research to investigate various pathophysiological mechanisms of this disease, the pathogenesis remains obscure. The investigators recently demonstrated increased duodenal permeability in FD patients, as assessed by mounting routine endoscopic duodenal biopsy specimens into Ussing chambers to measure transepithelial electrical resistance and passage of a paracellular fluorescent probe. Impaired intestinal barrier function can lead to increased uptake of luminal substances which can induce an immunological response in the mucosa. Interestingly, using transmission electron microscopy (TEM) in duodenal biopsies, the investigators recently observed the presence of a yet to be identified microorganism inside the epithelium and the lamina propria of a subset of FD patients (unpublished observations), suggesting increased translocation of microorganisms.
The aim of the project is to investigate whether FD patients display increased translocation of microorganisms in duodenal biopsies. The investigators will also test the effect of bile acid on translocation of microorganisms and therefore include 20 FD patients and 20 age- and gender-matched healthy volunteers in this study.
Detailed description
The participants will be expected on the department endoscopy of the University Hospital Gasthuisberg, Leuven, Belgium. They are asked to fill in a bundle of questionnaires concerning physical complaints, depression, anxiety (disturbances), pain/disease, body/interoceptive awareness, trauma/abuse and personality. Endoscopy will be performed and up to 8 biopsies will be obtained from the duodenum. All endoscopies will be performed by an experienced endoscopist. Biopsies will be mounted in Ussing chambers and the mucosal compartment will be exposed to commercially available fluorescein-conjugated microorganisms. Uptake of microorganisms will be evaluated by analyzing the serosal compartment and by confocal microscopy of the biopsies. These experiments will also be performed in combination with exposure to bile acids separately and jointly, to assess if bacterial translocation can be exacerbated by these endogenous luminal factors individually and synergistically.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gastroduodenoscopy | Other | Procedure: Gastroduodenoscopyall participants undergo a gastroduodenoscopy to use the biopsies in an Ussing chamber experiment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Three days before the measurement: no smoking and drinking alcohol
- 12 hours before the measurement: no drinking and eating
Key exclusion criteria (8 listed)
- symptoms or history of gastrointestinal disease
- first degree relatives with celiac disease
- diabetes mellitus
- allergy/atopy (eczema, asthma, allergic rhinoconjunctivitis)
- coagulation disorders/anticoagulant therapy
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 |
|---|---|---|
| GastroduodenoscopyGastroduodenoscopy with duodenal biospies: A tube is placed via the mouth into the second part of the duodenum. Biopsy forceps is used to take duodenal biopsies. | Procedure or surgery | gastroduodenoscopy |
Primary outcome
Bacterial uptake in the duodenal biopsy measured by fluorescent intensity at the basolateral side of the ussing chamber setup.
Time frame: 120 minutes
duodenal uptake of fluorescein conjugated microorganisms
1 secondary outcome
duodenal permeability assessed by measuring transepithelial electrical resistance in the Ussing chamber setup
Time frame: 120 minutes
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 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Functional Dyspepsia
Active, not recruitingPhase 1
AutoSTEA for Adults With Functional Dyspepsia
Functional Dyspepsia
Recruiting
Probiotic and Ginger Supplement for Symptoms and Quality of Life in Functional Dyspepsia (SUBTILE)
Functional Dyspepsia
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
RecruitingPhase 4
Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia
Functional Dyspepsia, Probiotics
RecruitingPhase 2
Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction-H1/H2
Functional Gastrointestinal Disorders
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.
Jan Tack, Professor principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastroduodenoscopy in people with Functional Dyspepsia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 2 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: finished, as of the sponsor's last update on 3 Jul 2024. 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 Belgium. 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?
Bacterial uptake in the duodenal biopsy measured by fluorescent intensity at the basolateral side of the ussing chamber setup. (time frame: 120 minutes). 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 3 Jul 2024.