GI Motility DisorderPhase 4NCT05071781
Effect of CRH on Duodenal Markers and Gastric Sensorimotor Function
A Phase 4 study testing Corticotropin-release hormone in people with GI Motility Disorder, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
In the present study, during Part 1, after a baseline gastroduodenoscopy, the investigators will perform a gastroduodenoscopy twice, to take duodenal biopsies before and 2 hours after administration of CRH/placebo. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- GI Motility Disorder
- What is being tested?
- Corticotropin-release hormone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 21 May 2021to 19 Dec 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntary written informed consent of the participant has been obtained prior to any screening procedures
- Women of child-bearing potential agree to apply a highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses.
- Healthy volunteers
- Subjects aged 18-55 years old (55y included).
- Male or female subjects.
- Subjects who are capable to understand the study and the questionnaires, and to comply with the study requirements.
Who cannot join
- Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
- Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive
- Presence of a history of gastrointestinal surgery other than appendectomy
- Presence of organic or functional gastrointestinal disease
- Presence of gastro-intestinal symptoms
Show all 22Show fewer
- Major psychiatric disorder such as major depression
- Presence of any disease affecting the gastrointestinal tract or hepatobiliary system.
- History of allergic reaction to CRH
- BMI equal to 30 mg/kg² or higher.
- Use of drugs included in this list:
- Opioids (unless short intake for acute pain and > 1month ago)
- Amitriptyline or mirtazapine; other antidepressants are allowed if the HV is on a stable dose and the drug is not combined with other antidepressants.
- Corticosteroids
- Antihistaminic drugs (last 2 weeks)
- Proton pump inhibitors (last 2 weeks)
- Disodiumchromoglycate or other mast cell stabilizers (last 2 weeks)
- Leukotriene receptor antagonists (last 2 weeks)
- NSAIDs (last 2 weeks)
- Antibiotics (last 2 months)
- Probiotics (last 2 weeks)
- Other medication: to be discussed with physician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Corticotropin Release Hormone on Duodenal Markers and Gastric Sensorimotor Function in Healthy Volunteers
In the present study, during Part 1, after a baseline gastroduodenoscopy, the investigators will perform a gastroduodenoscopy twice, to take duodenal biopsies before and 2 hours after administration of CRH/placebo. The investigators will measure mucosal integrity and markers of immune activation as outlined in Parts A and B, and will use transmission electron microscopy to evaluate mast cell and eosinophil degranulation. After an interval period of at least 1 week, CRH or placebo will be administrated again in a crossover fashion.
As a complementary study, the investigators will also test the effect of ex vivo mast cell blockade by lodoxamide to evaluate whether mast cells are involved in the hypothesized effect of CRH on duodenal permeability.
Read more
In a second part of this study, Part 2, the investigators will perform a gastric barostat, to measure the gastric accommodation and sensitivity to distension, and a carbon-13-octanoic acid breath test to measure the gastric emptying time after administration of CRH/placebo.
Healthy volunteers will have the option to choose to which part of the study (part 1 or 2) they wish to participate. They can also choose to cooperate to both study parts if preferred.
- Conditions
- GI Motility Disorder
- Being tested
- Corticotropin-release hormone
- Keywords
- cortisol releasing hormone, 3.1 Functional dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticotropin-release hormoneDrug
intravenous CRH (100 µg)
Corticotropin-release hormoneDrug
a bolus dose (CRH 100 µg or placebo) will be administered, followed by a continuous infusion (CRH 1 µg/kg/h or placebo)
| Study group | Role | What they receive |
|---|---|---|
| Cortisol releasing hormone group | Active comparator | HVs will start with CRH infusion. Receives: Drug: Corticotropin-release hormone |
| Placebo (sodium choride) group | Placebo comparator | HVs will start with NaCl 0.9% (placebo) infusion Receives: Drug: Corticotropin-release hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of corticotrophin release hormone (CRH) on duodenal mast cell count
Duodenal mast cells (c-kit) will be counted per mm2 via stained duodenal biopsy sections.
Measured: 2 hours after CRH/placebo
The effect of CRH on sensitivity to gastric distention (part 2)
Visceral sensitivity will be measured by barostat. Discomfort threshold will be defined as the first level of pressure and the corresponding volume that provokes discomfort. Pressure thresholds will be expressed both as pressures relative to minimal distending pressure and as absolute pressures.
Measured: 30 minutes after CRH/placebo
Secondary outcomes (6)
The effect of CRH on duodenal eosinophilia
Duodenal eosinophils (H\&E) will be counted per mm2 via stained duodenal biopsy sections.
Measured: 2 hours after CRH/placebo
The effect of CRH on duodenal mucosal permeability
Duodenal mucosa permeability on duodenal biopsies using adapted mini-Ussing chambers
Measured: 2 hours after CRH/placebo
The effect of CRH on gastric emptying time
Gastric emptying time in minutes t (1/2) will be measured by 13C-octanoic acid breath test.
Measured: 30 minutes after CRH/placebo
The effect of CRH on gastric accommodation
Gastric accommodation will be measured by barostat. Accommodation to a meal will be expressed as the average increase in intragastric volume during the first 4 postprandial hours.
Measured: 30 minutes after CRH/placebo
The effect of CRH on gastroduodenal symptoms.
Assessments using Visual Analog Score for GI symptoms which including pain, nausea, bloating, vomiting.
Measured: Every 15 minutes during CRH/placebo infusion for 4 hours
The effect of CRH on salivary cortisol level
Salivary cortisol level in nmol/L during placebo or CRH infusion
Measured: Right before CRH/placebo injection, 15, 30, 60, 120 minutes after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start21 May 2021
- Primary completion19 Dec 2022
- Study completion19 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GI Motility DisorderStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- To assess the effect of the CRH on on duodenal mast cell count, eosinophil count, immune activation and mucosal permeability, gastric accommodation, gastric sensitivity to distension and gastric emptying time, an interventional study will be conducted in 20 healthy subjects. The study is designed as a double-blind randomized crossover study with at least 7 days between the different study days.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- 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
- NCT05071781
- Sponsor's protocol ID
- S65020
- Status last verified
- Jul 2024
- First submitted
- 16 Aug 2021
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Trial will be conducted in compliance with the requirements of the EU General Data Protection Regulation 2016/679 (GDPR), the relevant Belgian laws implementing the GDPR including the Belgian Privacy Act of 30 July 2018 on the protection of privacy in relation to the processing of personal data. Any collection, processing and disclosure of personal data, such as participant health and medical information is subject to compliance with the aforementioned personal data protection laws.
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
- The Effect of Corticotropin Release Hormone on Duodenal Markers and Gastric Sensorimotor Function in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05071781
- Acronym / sponsor ID
- S65020
- Conditions
- GI Motility Disorder
- Keywords
- cortisol releasing hormone, 3.1 Functional dyspepsia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 21 May 2021 (actual)
- Primary completion
- 19 Dec 2022 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 8 Oct 2021 (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 the present study, during Part 1, after a baseline gastroduodenoscopy, the investigators will perform a gastroduodenoscopy twice, to take duodenal biopsies before and 2 hours after administration of CRH/placebo. The investigators will measure mucosal integrity and markers of immune activation as outlined in Parts A and B, and will use transmission electron microscopy to evaluate mast cell and eosinophil degranulation. After an interval period of at least 1 week, CRH or placebo will be administrated again in a crossover fashion.
As a complementary study, the investigators will also test the effect of ex vivo mast cell blockade by lodoxamide to evaluate whether mast cells are involved in the hypothesized effect of CRH on duodenal permeability.
In a second part of this study, Part 2, the investigators will perform a gastric barostat, to measure the gastric accommodation and sensitivity to distension, and a carbon-13-octanoic acid breath test to measure the gastric emptying time after administration of CRH/placebo.
Healthy volunteers will have the option to choose to which part of the study (part 1 or 2) they wish to participate. They can also choose to cooperate to both study parts if preferred.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- To assess the effect of the CRH on on duodenal mast cell count, eosinophil count, immune activation and mucosal permeability, gastric accommodation, gastric sensitivity to distension and gastric emptying time, an interventional study will be conducted in 20 healthy subjects. The study is designed as a double-blind randomized crossover study with at least 7 days between the different study days.
| Arm | Type | Receives |
|---|---|---|
| Cortisol releasing hormone group | Active comparator | Drug: Corticotropin-release hormoneHVs will start with CRH infusion. |
| Placebo (sodium choride) group | Placebo comparator | Drug: Corticotropin-release hormoneHVs will start with NaCl 0.9% (placebo) infusion |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Voluntary written informed consent of the participant has been obtained prior to any screening procedures
- Women of child-bearing potential agree to apply a highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses.
- Healthy volunteers
- Subjects aged 18-55 years old (55y included).
- Male or female subjects.
Key exclusion criteria (22 listed)
- Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
- Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive
- Presence of a history of gastrointestinal surgery other than appendectomy
- Presence of organic or functional gastrointestinal disease
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 |
|---|---|---|
| Corticotropin-release hormoneintravenous CRH (100 µg) | Drug | Cortisol releasing hormone group, Placebo (sodium choride) group |
| Corticotropin-release hormonea bolus dose (CRH 100 µg or placebo) will be administered, followed by a continuous infusion (CRH 1 µg/kg/h or placebo) | Drug | Cortisol releasing hormone group, Placebo (sodium choride) group |
Primary outcome
The effect of corticotrophin release hormone (CRH) on duodenal mast cell count
Time frame: 2 hours after CRH/placebo
Duodenal mast cells (c-kit) will be counted per mm2 via stained duodenal biopsy sections.
The effect of CRH on sensitivity to gastric distention (part 2)
Time frame: 30 minutes after CRH/placebo
Visceral sensitivity will be measured by barostat. Discomfort threshold will be defined as the first level of pressure and the corresponding volume that provokes discomfort. Pressure thresholds will be expressed both as pressures relative to minimal distending pressure and as absolute pressures.
6 secondary outcomes
The effect of CRH on duodenal eosinophilia
Time frame: 2 hours after CRH/placebo
The effect of CRH on duodenal mucosal permeability
Time frame: 2 hours after CRH/placebo
The effect of CRH on gastric emptying time
Time frame: 30 minutes after CRH/placebo
The effect of CRH on gastric accommodation
Time frame: 30 minutes after CRH/placebo
The effect of CRH on gastroduodenal symptoms.
Time frame: Every 15 minutes during CRH/placebo infusion for 4 hours
The effect of CRH on salivary cortisol level
Time frame: Right before CRH/placebo injection, 15, 30, 60, 120 minutes after injection
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. The Trial will be conducted in compliance with the requirements of the EU General Data Protection Regulation 2016/679 (GDPR), the relevant Belgian laws implementing the GDPR including the Belgian Privacy Act of 30 July 2018 on the protection of privacy in relation to the processing of personal data. Any collection, processing and disclosure of personal data, such as participant health and medical information is subject to compliance with the aforementioned personal data protection laws.
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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 Corticotropin-release hormone in people with GI Motility Disorder, 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 6 inclusion and 22 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. 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 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?
The effect of corticotrophin release hormone (CRH) on duodenal mast cell count (time frame: 2 hours after CRH/placebo). The study lists 2 primary outcomes in all. 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.