DyspepsiaPhase 4NCT02664051
Mast Cells in Acid-induced Intestinal Permeability
A Phase 4 study testing Nalcrom in people with Dyspepsia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
This is a randomized, double-blind, cross-over study in healthy volunteers. In the first part, the duodenum of the participants will be perfused with acid or saline, during which intragastric pressure will be monitored to assess activation of the duodenogastric reflex. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyspepsia
- What is being tested?
- Nalcrom
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2013to 29 Jun 2021
- Phase
- Phase 4
- 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
- healthy
Who cannot join
- - refused informed consent
- pregnant women or women who are breastfeeding
- symptoms or history of gastrointestinal disease
- diabetes mellitus
- coagulation disorders/anticoagulant therapy
- first degree relatives with celiac disease, Crohn's disease or type I diabetes mellitus
- taking antihistamines, ketotifen, cromoglycate, acetylsalicylates, NSAIDs, anticholinergics, theophylline, β2-agonists, codeine or opioid derivatives 2 weeks prior to the study
- taking steroid or immunosuppressive drugs 6 months prior to the study
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Translational Research Center for Gastrointestinal Disorders (TARGID), KU Leuven Campus Gasthuisberg O&N1
Leuven, Vlaams Brabant, 3000
About this study
Official title: The Role of Mast Cells on Duodenal Permeability After Duodenal Acid Perfusion in Healthy Volunteers
This is a randomized, double-blind, cross-over study in healthy volunteers. In the first part, the duodenum of the participants will be perfused with acid or saline, during which intragastric pressure will be monitored to assess activation of the duodenogastric reflex. After perfusion, duodenal biopsies will be collected to evaluate mucosal integrity. In the second part, healthy volunteers are treated with the mast cell stabilizer disodium cromoglycate or with a placebo during 14 days. Subsequently, the duodenum will be perfused with acid and intragastric pressure and mucosal integrity will be evaluated.
Read the detailed description
Despite intensive research, the pathophysiology of functional dyspepsia remains unknown. The investigators recently demonstrated that functional dyspepsia patients display impaired duodenal mucosal integrity and low-grade mucosal inflammation. As studies have also shown that functional dyspepsia patients present with an increased spontaneous duodenal acid exposure, the hypothesis of this study is that increased duodenal acid exposure results in increased duodenal permeability via mast cell activation. This will also induce activation of the duodenogastric reflex, resulting in gastric relaxation, eventually leading to the generation of dyspeptic symptoms. The general aim of this project is to assess the effect of mast cell inhibition on duodenal mucosal integrity and intragastric pressure of healthy volunteers after acid infusion in the duodenum.
The study will be a randomized, double-blind, cross-over study in 20 healthy volunteers and consists of 2 parts. (1) In the first part, 10 healthy volunteers will be perfused with acid (0.1N HCl) or 0.9% saline during 30 minutes at a rate of 5 mL/min with an interval of at least one month. During acid/saline perfusion, intragastric pressure will be measured with a high resolution manometry system to evaluate activation of the duodenogastric reflex. Dyspeptic symptoms will be scored 1 minute before and every 5 minutes during the infusion. After perfusion, endoscopy will be performed and duodenal biopsies will be obtained to evaluate mucosal integrity using Ussing chambers and by assessing the expression of cell-to-cell adhesion proteins (real-time PCR, immunofluorescence and western blot). (2) In the second part, 10 healthy volunteers will be perfused with acid after a placebo treatment and after treatment with the mast cell stabilizer disodium cromoglycate 100mg 4x2/day (with an interval of at least one month). The rest of the study continues as described in part 1.
- Conditions
- Dyspepsia
- Being tested
- Nalcrom, placebo
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NalcromDrug
Drug: disodium cromoglycate 100mg 4x2 daily
Other Names:
- Nalcrom
placeboDrug
100mg 4x2 daily mannitol
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | mannitol Receives: Drug: placebo |
| disodium cromoglycate | Active comparator | disodium cromoglycate Receives: Drug: Nalcrom |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of transepithelial resistance (mucosal integrity) of duodenal biopsies after duodenal saline or acid perfusion, after treatment with placebo or a mast cell stabilizer
Measured: 2 weeks
Secondary outcomes (1)
evaluation of intragastric pressure during duodenal saline or acid perfusion, after treatment with placebo or a mast cell stabilizer
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startAug 2013
- Primary completionDec 2016
- Study completion29 Jun 2021
Why it stopped: Inactive
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664051
- Sponsor's protocol ID
- S56881
- Other IDs
- 2015-000244-42, 2015
- Status last verified
- Nov 2015
- First submitted
- 24 Nov 2015
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Mast Cells on Duodenal Permeability After Duodenal Acid Perfusion in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02664051
- Acronym / sponsor ID
- S56881
- Conditions
- Dyspepsia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inactive
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- 29 Jun 2021 (actual)
- First posted
- 26 Jan 2016 (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.
This is a randomized, double-blind, cross-over study in healthy volunteers. In the first part, the duodenum of the participants will be perfused with acid or saline, during which intragastric pressure will be monitored to assess activation of the duodenogastric reflex. After perfusion, duodenal biopsies will be collected to evaluate mucosal integrity. In the second part, healthy volunteers are treated with the mast cell stabilizer disodium cromoglycate or with a placebo during 14 days. Subsequently, the duodenum will be perfused with acid and intragastric pressure and mucosal integrity will be evaluated.
Detailed description
Despite intensive research, the pathophysiology of functional dyspepsia remains unknown. The investigators recently demonstrated that functional dyspepsia patients display impaired duodenal mucosal integrity and low-grade mucosal inflammation. As studies have also shown that functional dyspepsia patients present with an increased spontaneous duodenal acid exposure, the hypothesis of this study is that increased duodenal acid exposure results in increased duodenal permeability via mast cell activation. This will also induce activation of the duodenogastric reflex, resulting in gastric relaxation, eventually leading to the generation of dyspeptic symptoms. The general aim of this project is to assess the effect of mast cell inhibition on duodenal mucosal integrity and intragastric pressure of healthy volunteers after acid infusion in the duodenum.
The study will be a randomized, double-blind, cross-over study in 20 healthy volunteers and consists of 2 parts. (1) In the first part, 10 healthy volunteers will be perfused with acid (0.1N HCl) or 0.9% saline during 30 minutes at a rate of 5 mL/min with an interval of at least one month. During acid/saline perfusion, intragastric pressure will be measured with a high resolution manometry system to evaluate activation of the duodenogastric reflex. Dyspeptic symptoms will be scored 1 minute before and every 5 minutes during the infusion. After perfusion, endoscopy will be performed and duodenal biopsies will be obtained to evaluate mucosal integrity using Ussing chambers and by assessing the expression of cell-to-cell adhesion proteins (real-time PCR, immunofluorescence and western blot). (2) In the second part, 10 healthy volunteers will be perfused with acid after a placebo treatment and after treatment with the mast cell stabilizer disodium cromoglycate 100mg 4x2/day (with an interval of at least one month). The rest of the study continues as described in part 1.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebomannitol |
| disodium cromoglycate | Active comparator | Drug: Nalcromdisodium cromoglycate |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy
Key exclusion criteria (8 listed)
- - refused informed consent
- pregnant women or women who are breastfeeding
- symptoms or history of gastrointestinal disease
- diabetes mellitus
- 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 |
|---|---|---|
| NalcromDrug: disodium cromoglycate 100mg 4x2 daily Other Names: • Nalcrom | Drug | disodium cromoglycate |
| placebo100mg 4x2 daily mannitol | Drug | placebo |
Primary outcome
evaluation of transepithelial resistance (mucosal integrity) of duodenal biopsies after duodenal saline or acid perfusion, after treatment with placebo or a mast cell stabilizer
Time frame: 2 weeks
1 secondary outcome
evaluation of intragastric pressure during duodenal saline or acid perfusion, after treatment with placebo or a mast cell stabilizer
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: Inactive). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nalcrom in people with 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 1 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: stopped early, as of the sponsor's last update on 10 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. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Inactive). 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?
evaluation of transepithelial resistance (mucosal integrity) of duodenal biopsies after duodenal saline or acid perfusion, after treatment with placebo or a mast cell stabilizer (time frame: 2 weeks). 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 10 Jul 2024.