Sensitivity (Hyper); GastrointestinalPhase 4CRHNCT02674256

The Effect of Corticotrophin-releasing Hormone (CRH) on Esophageal Sensitivity in Healthy Volunteers

A Phase 4 study testing CRH in people with Sensitivity (Hyper); Gastrointestinal, run by Universitaire Ziekenhuizen KU Leuven.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Introduction and aim Stress is well known to affect visceral sensitivity in Human. The investigators speculate that visceral hypersensitivity plays an important role in symptom perception in gastro-esophageal reflux disease (GERD). Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Sensitivity (Hyper); Gastrointestinal
What is being tested?: CRH
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 15 participants
Where: No sites listed yet
Study dates: Mar 2014to May 2014
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 volunteers
age between 18 to 60 years

Who cannot join

no history of gastrointestinal symptoms or complaints
history of allergic reaction to CRH
pregnancy or lactation
concomitant administration of monoamine oxidase inhibitors (MAOI), verapamil or diltiazem or medication affecting esophageal motility
significant co-morbidities (neuromuscular, psychiatric, cardiovascular, pulmonary, endocrine, autoimmune, renal and hepatic)
prior history of esophageal, ENT or gastric surgery or endoscopic anti-reflux procedure
history of gastrointestinal disease and first degree relatives with Crohn's disease or celiac disease

About this study

Official title: The Effect of Corticotrophin-releasing Hormone (CRH) on Esophageal Sensitivity in Healthy Volunteers: A Randomized, Single-blind, Placebo-controlled Study

Introduction and aim

Stress is well known to affect visceral sensitivity in Human. The investigators speculate that visceral hypersensitivity plays an important role in symptom perception in gastro-esophageal reflux disease (GERD). The role of acute stress mimicked by corticotrophin releasing hormone (CRH) administration on esophageal sensitivity has not been studied. The investigators hypothesize that stress mediated through CRH-release increases esophageal sensitivity. A first step in the investigation of this hypothesis is to study whether administration of CRH has an influence on esophageal sensitivity in healthy volunteers (HV). Therefore, the aim of this study is to investigate the effect of CRH-administration on esophageal sensitivity in a group of HV.

Methods

The study will be performed in cross-over on 15 HV with no prior history of digestive disease. Esophageal sensitivity will be tested by multimodal stimulation on two sessions (placebo and CRH-administration), with an interval at least of one week. The two sessions will be scheduled by randomization for every subject. After blinded administration of CRH 100µg or placebo IV, esophageal sensitivity will be assessed using a multimodal esophageal stimulation probe which allows thermal, mechanical, electrical and chemical stimulations of the esophagus. Esophageal sensitivity will be assessed using Visual Analogue Scale (VAS), the mood with specific questionnaires (Manikin Self assessment SAM, Profile of Mood Schedule (POMS, State Trait Anxiety Inventory (STAI)) and the cortisol with salivary samples.

Statistical analysis

Esophageal sensitivity for the different stimuli (heat, mechanical, electrical and chemical) will be compared between CRH and placebo conditions. To determine the stress-inducing capability of CRH-administration, the POMS questionnaire, STAI, Manikin self assessment and cortisol levels after the stress-protocol will be compared with the basal measurements.

Perspectives

If CRH-administration increases esophageal sensitivity, a stress model could be applied to investigate the influence of a real life stressor on esophageal sensitivity in healthy subjects. In a third part, a mast-cell stabilizing drug could be tested after administration of a stressor in order to investigate its role on esophageal sensitivity. In the future, this might be proposed to refractory GERD in a controlled randomized trial.

Read the detailed description

INTRODUCTION Gastro-esophageal reflux disease (GERD) is the presence of symptoms (heartburn, regurgitation) or lesions that can be attributed to the reflux of gastric contents into the esophagus. In humans, pain is a multimodal experience composted of sensory, physiological and psychological aspects. In order to mimic the clinical situation, experimental models should be based on multimodal testing regimens in which different receptors and central nervous system mechanisms are activated. Typical and atypical symptoms may not only arise from acid reflux, but also from reflux with less acidic pH (pH 4-7). In GERD patients with persisting symptoms on proton pump inhibitor (PPI) therapy, ongoing weakly acidic reflux is well established as an important underlying factor. The basis for symptom generation during weakly acidic reflux remains to be determined, but acid sensitivity in the pH range 4-7, mechanical distension, sensitivity to other chemical factors and esophageal hypersensitivity to physiological levels of reflux have been proposed. The investigators speculate that visceral hypersensitivity plays an important role in symptom perception. This is suggested by the reflux parameters that are usual within the physiological number during PPI therapy. Also, the investigators previously demonstrated that refractory GERD patients have increased visceral hypersensitivity for thermal, chemical and mechanical esophageal stimulation compared to HV. Stress is well known to affect visceral sensitivity in humans. A majority of patients with GERD report stress as an important factor triggering symptom exacerbation. A real-life stressor could exacerbate heartburn in GERD patients by enhancing perceptual response to esophageal acid exposure. The interaction between psychological state and GI function is a complex and developing field. The brain-gut axis, mediating the effects of stress on the Gastrointestinal (GI) tract, has been considered a pivotal player in the pathogenesis of functional GI disorders like irritable bowel syndrome (IBS) and functional dyspepsia (FD). A possible mechanism of stress-induced visceral sensitivity could be the barrier dysfunction. A study performed in humans, showed that an acute psychological stressor induces hyperpermeability in a mast cell dependent fashion and exogenous peripheral CRH recapitulated its effects on barrier function. This increase in intestinal permeability is a phenomenon which appears as a prerequisite for visceral hypersensitivity. The acute role of CRH on esophageal sensitivity has not been studied.
OBJECTIVE Stress increases permeability via CRH-mediated mast cell activation. The investigators hypothesize that stress mediated through CRH-release increases esophageal sensitivity. Therefore, the aim of our study is to investigate the effect of CRH-administration on esophageal sensitivity in a group of HV.
GENERAL DESCRIPTION Studies will be performed in HV. All participants will receive and sign a copy of the informed consent before initiation of the study. Esophageal sensitivity will be tested by multimodal stimulation on two sessions (placebo and CRH-administration).
MATERIALS AND METHODS Studies will be performed using a multimodal esophageal stimulation probe which allows esophageal thermal, mechanical, electrical and chemical stimulations. During each stimulation, HV will record symptom perception using VAS. First perception (VAS=1), pain perception threshold (VAS=5) and pain tolerance threshold (VAS=7) will be recorded. All stimulations will be immediately terminated when the VAS 7 is reached. At the time of VAS 7, subjects will be asked to draw the referred pain area, to identify pain location. Thermal stimulation will be performed by re-circulating a saline solution, heated by a water bath, through the balloon mounted on the probe. Stimulation temperature will be steadily increased by increasing the flow rate from the water bath to the balloon. The volume in the balloon will be kept constant (5ml) to avoid mechanical stimulation. A temperature sensor in the balloon will continuously monitor the stimulation temperature, which is displayed online on a computer throughout the study. Mechanical stimulation will be performed by distension of the balloon. The flow of saline into the balloon, inducing the distension, is regulated by a computer controlled pump. The volume in the balloon is displayed on the computer screen throughout the stimulation. Mechanical stimulations will be performed with water of 37 degrees Celsius, to avoid thermal stimulation. Electrical stimulation will be performed by 2 electrodes mounted on the probe. Single burst pulses will be given with duration of 1ms at 200Hz. The amplitude of the pulses will increase with steps of 0.5mA. The maximum intensity is limited to 50 mA, as previous studies have shown atrial capturing with higher intensities. Electrocardiogram (ECG) monitoring will be performed as a safety measure during the electrical stimulations. Chemical stimulation will be performed by infusing an acidic solution (HCl 0.1N) in the distal esophagus, with a flow rate of 2ml/min. The stimulation will last for a maximum of 30 min. After an overnight fast subjects will come to the endoscopy unit of the Universitary Hospital of Leuven,Gasthuisberg, where the study will be performed. Two sessions will be scheduled for every subject: one placebo and one CRH session, with one week interval at least between each of them. Sessions will run in a single-blind way, as far as the placebo or drugs are concerned. The order of placebo and CRH-administration will be randomized by drawing cards from a box of cards determining the sequence. At the beginning of the session, the multimodal stimulation probe will be positioned through the mouth. After the probe is positioned in the esophagus, it will be fixed to the chin and the subject will remain in semi-recumbent position for the entire study. Before the actual stimulations start, there will be an adaptation period of 15 min, to get used to the feeling of the probe and to provide instructions for the correct use of the VAS meter. Fifteen minutes after the ingestion of the multimodal esophageal stimulation probe, 100µg CRH powder for injection (CRH ferring®, Ferring, Aalst, Belgium) and 1mL of NaCl 0.9% will be put together, then the solution will be injected intravenously over the course of 1 minute. With this dose, side-effects are limited to transient facial flushing that lasts from 5 to 45 min in 75% of patients. During placebo sessions, 1mL of NaCl 0.9% will be put in an identical syringe as the one used for CRH administration, and then injected intravenously (IV). In this way the HV will be blinded for the administration of CRH or placebo. Over time, each HV will receive placebo or CRH in the first session in a random sequence. In the second session, the subject will receive the other product that he/she didn't receive the first time. Salivary samples will be obtained at each session to determine salivary cortisol immediately before placebo or CRH-administration, at 30, 60, 90 and 120 min after administration. Salivary cortisol will be determined by ELISA. On every session, an assessment of general mood will be performed by the POMS and the STAI state questionnaires before and after the stimulation tests. The POMS consists of words describing different feelings and emotions at the present moment. The STAI state is validated, and widely used measuring transitory anxiety states.
DATA ANALYSIS The main objective is to show a difference for thermal stimulation with or without injection of CRH. The number of HV to be included is calculated with a medium comparison test. For a first species of risk α of 5% and a unilateral formulation, the investigators need to include 15 HV in total in order to highlight the expected differences and ensure a power of 80%. Temperature, volume, cross-section area of the balloon, pressure and electrical current will be measured at first perception, pain perception threshold and pain tolerance threshold and will be used to determine esophageal sensitivity. Esophageal sensitivity for the different stimuli (heat, mechanical, electrical and chemical) will be compared between CRH and placebo conditions. To determine the stress-inducing capability of CRH-administration, the POMS, STAI and cortisol levels after the stress-protocol will be compared with the basal measurements of the first study day.
PERSPECTIVES If CRH-administration increases esophageal sensitivity, a stress model could be applied to investigate the influence of a real life stressor on esophageal sensitivity in HV. In a third part, a mast-cell stabilizing drug could be tested after administration of a stressor in order to investigate its role on esophageal sensitivity. In the future, this might be proposed to refractory GERD in a controlled randomized trial.

Conditions: Sensitivity (Hyper); Gastrointestinal
Being tested: CRH, Placebo
Keywords: health, age between 18 to 60 years old, no history of gastrointestinal symptoms or complaints
Medical subject headings: Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CRHDrug
Also called CRH ferring®, Ferring, Aalst, Belgium
100µg CRH powder for injection (CRH ferring®, Ferring, Aalst, Belgium) and 1 mL of NaCl 0.9% will be put together, then the solution will be injected intravenously over the course of 1 minute
PlaceboOther
Also called Saline solution
1 mL of NaCl 0.9% will be injected intravenously over the course of one minute

Study groups in NCT02674256
Study group	Role	What they receive
CRH injection	Active comparator	Intervention: intravenous injection of CRH 100µg CRH powder for injection (CRH ferring®, Ferring, Aalst, Belgium) and 1 mL of NaCl 0.9% will be put together then the solution will be injected IV over the course of 1 minute Receives: Drug: CRH
placebo injection	Placebo comparator	Intervention: intravenous saline injection 1mL of saline will be injected intravenously over the course of 1 minute Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Measurement of changes in esophageal sensitivity after IV CRH administration
Investigation of the effect of CRH-administration on esophageal sensitivity to multimodal stimulation in a group of healthy volunteers. This will be assessed by comparing the Temperature values (°C) of the stimulation tests between the placebo and CRH condition to see if CRH affects the sensitivity to increasing temperature.
Measured: 2 sessions per HV with at least one week interval, duration of each session: approximately 2 hours and 30 minutes. Temperature stimulation: 30 minutes
Measurement of changes in esophageal sensitivity after IV CRH administration
Investigation of the effect of CRH-administration on esophageal sensitivity to multimodal stimulation in a group of healthy volunteers. This will be assessed by comparing the balloon volumes (volume in ml) of the stimulation tests between the placebo and CRH condition to see if CRH affects the sensitivity to increasing balloon volume.
Measured: 2 sessions per HV with at least one week interval, duration of each session: approximately 2 hours and 30 minutes. Mechanical stimulation: 30 minutes
Measurement of changes in esophageal sensitivity after IV CRH administration
Investigation of the effect of CRH-administration on esophageal sensitivity to multimodal stimulation in a group of healthy volunteers. This will be assessed by comparing the tolerated intensity of the electrical pulses (mA) of the stimulation tests between the placebo and CRH condition to see if CRH affects the sensitivity to increasing electrical pulses.
Measured: 2 sessions per HV with at least one week interval, duration of each session: approximately 2 hours and 30 minutes. Electrical stimulation: 30 minutes
Measurement of changes in esophageal sensitivity after IV CRH administration
Investigation of the effect of CRH-administration on esophageal sensitivity to multimodal stimulation in a group of healthy volunteers. This will be assessed by comparing the volume of infused acid (ml) of the stimulation tests between the placebo and CRH condition to see if CRH affects the sensitivity to acid infusion.
Measured: 2 sessions per HV with at least one week interval, duration of each session: approximately 2 hours and 30 minutes. Chemical stimulation: 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2014May 2014

First posted4 Feb 2016 (estimated)
Study startMar 2014
Primary completionMay 2014
Study completionMay 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Sensitivity (Hyper); GastrointestinalStudies 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
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02674256
Sponsor's protocol ID: S56177
Acronym: CRH
Status last verified: Jan 2016
First submitted: 25 Mar 2014
Last updated: 4 Feb 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Corticotrophin-releasing Hormone (CRH) on Esophageal Sensitivity in Healthy Volunteers: A Randomized, Single-blind, Placebo-controlled Study
ClinicalTrials.gov ID: NCT02674256
Acronym / sponsor ID: CRH / S56177
Conditions: Sensitivity (Hyper); Gastrointestinal
Keywords: health, age between 18 to 60 years old, no history of gastrointestinal symptoms or complaints
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
Study start: Mar 2014
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 4 Feb 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.

Introduction and aim

Methods

Statistical analysis

Perspectives

Detailed description

INTRODUCTION Gastro-esophageal reflux disease (GERD) is the presence of symptoms (heartburn, regurgitation) or lesions that can be attributed to the reflux of gastric contents into the esophagus. In humans, pain is a multimodal experience composted of sensory, physiological and psychological aspects. In order to mimic the clinical situation, experimental models should be based on multimodal testing regimens in which different receptors and central nervous system mechanisms are activated. Typical and atypical symptoms may not only arise from acid reflux, but also from reflux with less acidic pH (pH 4-7). In GERD patients with persisting symptoms on proton pump inhibitor (PPI) therapy, ongoing weakly acidic reflux is well established as an important underlying factor. The basis for symptom generation during weakly acidic reflux remains to be determined, but acid sensitivity in the pH range 4-7, mechanical distension, sensitivity to other chemical factors and esophageal hypersensitivity to physiological levels of reflux have been proposed. The investigators speculate that visceral hypersensitivity plays an important role in symptom perception. This is suggested by the reflux parameters that are usual within the physiological number during PPI therapy. Also, the investigators previously demonstrated that refractory GERD patients have increased visceral hypersensitivity for thermal, chemical and mechanical esophageal stimulation compared to HV. Stress is well known to affect visceral sensitivity in humans. A majority of patients with GERD report stress as an important factor triggering symptom exacerbation. A real-life stressor could exacerbate heartburn in GERD patients by enhancing perceptual response to esophageal acid exposure. The interaction between psychological state and GI function is a complex and developing field. The brain-gut axis, mediating the effects of stress on the Gastrointestinal (GI) tract, has been considered a pivotal player in the pathogenesis of functional GI disorders like irritable bowel syndrome (IBS) and functional dyspepsia (FD). A possible mechanism of stress-induced visceral sensitivity could be the barrier dysfunction. A study performed in humans, showed that an acute psychological stressor induces hyperpermeability in a mast cell dependent fashion and exogenous peripheral CRH recapitulated its effects on barrier function. This increase in intestinal permeability is a phenomenon which appears as a prerequisite for visceral hypersensitivity. The acute role of CRH on esophageal sensitivity has not been studied.
OBJECTIVE Stress increases permeability via CRH-mediated mast cell activation. The investigators hypothesize that stress mediated through CRH-release increases esophageal sensitivity. Therefore, the aim of our study is to investigate the effect of CRH-administration on esophageal sensitivity in a group of HV.
GENERAL DESCRIPTION Studies will be performed in HV. All participants will receive and sign a copy of the informed consent before initiation of the study. Esophageal sensitivity will be tested by multimodal stimulation on two sessions (placebo and CRH-administration).
MATERIALS AND METHODS Studies will be performed using a multimodal esophageal stimulation probe which allows esophageal thermal, mechanical, electrical and chemical stimulations. During each stimulation, HV will record symptom perception using VAS. First perception (VAS=1), pain perception threshold (VAS=5) and pain tolerance threshold (VAS=7) will be recorded. All stimulations will be immediately terminated when the VAS 7 is reached. At the time of VAS 7, subjects will be asked to draw the referred pain area, to identify pain location. Thermal stimulation will be performed by re-circulating a saline solution, heated by a water bath, through the balloon mounted on the probe. Stimulation temperature will be steadily increased by increasing the flow rate from the water bath to the balloon. The volume in the balloon will be kept constant (5ml) to avoid mechanical stimulation. A temperature sensor in the balloon will continuously monitor the stimulation temperature, which is displayed online on a computer throughout the study. Mechanical stimulation will be performed by distension of the balloon. The flow of saline into the balloon, inducing the distension, is regulated by a computer controlled pump. The volume in the balloon is displayed on the computer screen throughout the stimulation. Mechanical stimulations will be performed with water of 37 degrees Celsius, to avoid thermal stimulation. Electrical stimulation will be performed by 2 electrodes mounted on the probe. Single burst pulses will be given with duration of 1ms at 200Hz. The amplitude of the pulses will increase with steps of 0.5mA. The maximum intensity is limited to 50 mA, as previous studies have shown atrial capturing with higher intensities. Electrocardiogram (ECG) monitoring will be performed as a safety measure during the electrical stimulations. Chemical stimulation will be performed by infusing an acidic solution (HCl 0.1N) in the distal esophagus, with a flow rate of 2ml/min. The stimulation will last for a maximum of 30 min. After an overnight fast subjects will come to the endoscopy unit of the Universitary Hospital of Leuven,Gasthuisberg, where the study will be performed. Two sessions will be scheduled for every subject: one placebo and one CRH session, with one week interval at least between each of them. Sessions will run in a single-blind way, as far as the placebo or drugs are concerned. The order of placebo and CRH-administration will be randomized by drawing cards from a box of cards determining the sequence. At the beginning of the session, the multimodal stimulation probe will be positioned through the mouth. After the probe is positioned in the esophagus, it will be fixed to the chin and the subject will remain in semi-recumbent position for the entire study. Before the actual stimulations start, there will be an adaptation period of 15 min, to get used to the feeling of the probe and to provide instructions for the correct use of the VAS meter. Fifteen minutes after the ingestion of the multimodal esophageal stimulation probe, 100µg CRH powder for injection (CRH ferring®, Ferring, Aalst, Belgium) and 1mL of NaCl 0.9% will be put together, then the solution will be injected intravenously over the course of 1 minute. With this dose, side-effects are limited to transient facial flushing that lasts from 5 to 45 min in 75% of patients. During placebo sessions, 1mL of NaCl 0.9% will be put in an identical syringe as the one used for CRH administration, and then injected intravenously (IV). In this way the HV will be blinded for the administration of CRH or placebo. Over time, each HV will receive placebo or CRH in the first session in a random sequence. In the second session, the subject will receive the other product that he/she didn't receive the first time. Salivary samples will be obtained at each session to determine salivary cortisol immediately before placebo or CRH-administration, at 30, 60, 90 and 120 min after administration. Salivary cortisol will be determined by ELISA. On every session, an assessment of general mood will be performed by the POMS and the STAI state questionnaires before and after the stimulation tests. The POMS consists of words describing different feelings and emotions at the present moment. The STAI state is validated, and widely used measuring transitory anxiety states.
DATA ANALYSIS The main objective is to show a difference for thermal stimulation with or without injection of CRH. The number of HV to be included is calculated with a medium comparison test. For a first species of risk α of 5% and a unilateral formulation, the investigators need to include 15 HV in total in order to highlight the expected differences and ensure a power of 80%. Temperature, volume, cross-section area of the balloon, pressure and electrical current will be measured at first perception, pain perception threshold and pain tolerance threshold and will be used to determine esophageal sensitivity. Esophageal sensitivity for the different stimuli (heat, mechanical, electrical and chemical) will be compared between CRH and placebo conditions. To determine the stress-inducing capability of CRH-administration, the POMS, STAI and cortisol levels after the stress-protocol will be compared with the basal measurements of the first study day.
PERSPECTIVES If CRH-administration increases esophageal sensitivity, a stress model could be applied to investigate the influence of a real life stressor on esophageal sensitivity in HV. In a third part, a mast-cell stabilizing drug could be tested after administration of a stressor in order to investigate its role on esophageal sensitivity. In the future, this might be proposed to refractory GERD in a controlled randomized trial.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
CRH injection	Active comparator	Drug: CRHIntervention: intravenous injection of CRH 100µg CRH powder for injection (CRH ferring®, Ferring, Aalst, Belgium) and 1 mL of NaCl 0.9% will be put together then the solution will be injected IV over the course of 1 minute
placebo injection	Placebo comparator	Other: PlaceboIntervention: intravenous saline injection 1mL of saline will be injected intravenously over the course of 1 minute

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

healthy volunteers
age between 18 to 60 years

Key exclusion criteria (7 listed)

no history of gastrointestinal symptoms or complaints
history of allergic reaction to CRH
pregnancy or lactation
concomitant administration of monoamine oxidase inhibitors (MAOI), verapamil or diltiazem or medication affecting esophageal motility
significant co-morbidities (neuromuscular, psychiatric, cardiovascular, pulmonary, endocrine, autoimmune, renal and hepatic)

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
CRHAlso: CRH ferring®, Ferring, Aalst, Belgium100µg CRH powder for injection (CRH ferring®, Ferring, Aalst, Belgium) and 1 mL of NaCl 0.9% will be put together, then the solution will be injected intravenously over the course of 1 minute	Drug	CRH injection
PlaceboAlso: Saline solution1 mL of NaCl 0.9% will be injected intravenously over the course of one minute	Other	placebo injection

Primary outcome

Measurement of changes in esophageal sensitivity after IV CRH administration
Time frame: 2 sessions per HV with at least one week interval, duration of each session: approximately 2 hours and 30 minutes. Temperature stimulation: 30 minutes
Investigation of the effect of CRH-administration on esophageal sensitivity to multimodal stimulation in a group of healthy volunteers. This will be assessed by comparing the Temperature values (°C) of the stimulation tests between the placebo and CRH condition to see if CRH affects the sensitivity to increasing temperature.
Measurement of changes in esophageal sensitivity after IV CRH administration
Time frame: 2 sessions per HV with at least one week interval, duration of each session: approximately 2 hours and 30 minutes. Mechanical stimulation: 30 minutes
Investigation of the effect of CRH-administration on esophageal sensitivity to multimodal stimulation in a group of healthy volunteers. This will be assessed by comparing the balloon volumes (volume in ml) of the stimulation tests between the placebo and CRH condition to see if CRH affects the sensitivity to increasing balloon volume.
Measurement of changes in esophageal sensitivity after IV CRH administration
Time frame: 2 sessions per HV with at least one week interval, duration of each session: approximately 2 hours and 30 minutes. Electrical stimulation: 30 minutes
Investigation of the effect of CRH-administration on esophageal sensitivity to multimodal stimulation in a group of healthy volunteers. This will be assessed by comparing the tolerated intensity of the electrical pulses (mA) of the stimulation tests between the placebo and CRH condition to see if CRH affects the sensitivity to increasing electrical pulses.
Measurement of changes in esophageal sensitivity after IV CRH administration
Time frame: 2 sessions per HV with at least one week interval, duration of each session: approximately 2 hours and 30 minutes. Chemical stimulation: 30 minutes
Investigation of the effect of CRH-administration on esophageal sensitivity to multimodal stimulation in a group of healthy volunteers. This will be assessed by comparing the volume of infused acid (ml) of the stimulation tests between the placebo and CRH condition to see if CRH affects the sensitivity to acid infusion.

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 4 Feb 2016.
Individual participant dataSharing planned: No

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 F Tack, MD, PhD principal investigator

KU Leuven

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing CRH in people with Sensitivity (Hyper); Gastrointestinal, run by Universitaire Ziekenhuizen KU Leuven.

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 7 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 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

Measurement of changes in esophageal sensitivity after IV CRH administration (time frame: 2 sessions per HV with at least one week interval, duration of each session: approximately 2 hours and 30 minutes. Temperature stimulation: 30 minutes). The study lists 4 primary outcomes in all. 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 NCT02674256.

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 4 Feb 2016.