- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05071781
Effect of CRH on Duodenal Markers and Gastric Sensorimotor Function
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.
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
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Leuven, Belgique, 3000
- Recrutement
- I-Hsuan Huang
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Contact:
- I-Hsuan Huang
- Numéro de téléphone: 016194938
- E-mail: ihsuan.huang@kuleuven.be
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Cortisol releasing hormone group
HVs will start with CRH infusion.
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intravenous CRH (100 µg)
a bolus dose (CRH 100 µg or placebo) will be administered, followed by a continuous infusion (CRH 1 µg/kg/h or placebo)
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Comparateur placebo: Placebo (sodium choride) group
HVs will start with NaCl 0.9% (placebo) infusion
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intravenous CRH (100 µg)
a bolus dose (CRH 100 µg or placebo) will be administered, followed by a continuous infusion (CRH 1 µg/kg/h or placebo)
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
The effect of corticotrophin release hormone (CRH) on duodenal mast cell count
Délai: 2 hours after CRH/placebo
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Duodenal mast cells (c-kit) will be counted per mm2 via stained duodenal biopsy sections.
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2 hours after CRH/placebo
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The effect of CRH on sensitivity to gastric distention (part 2)
Délai: 30 minutes after CRH/placebo
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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.
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30 minutes after CRH/placebo
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
The effect of CRH on duodenal eosinophilia
Délai: 2 hours after CRH/placebo
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Duodenal eosinophils (H&E) will be counted per mm2 via stained duodenal biopsy sections.
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2 hours after CRH/placebo
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The effect of CRH on duodenal mucosal permeability
Délai: 2 hours after CRH/placebo
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Duodenal mucosa permeability on duodenal biopsies using adapted mini-Ussing chambers
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2 hours after CRH/placebo
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The effect of CRH on gastric emptying time
Délai: 30 minutes after CRH/placebo
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Gastric emptying time in minutes t (1/2) will be measured by 13C-octanoic acid breath test.
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30 minutes after CRH/placebo
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The effect of CRH on gastric accommodation
Délai: 30 minutes after CRH/placebo
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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.
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30 minutes after CRH/placebo
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The effect of CRH on gastroduodenal symptoms.
Délai: Every 15 minutes during CRH/placebo infusion for 4 hours
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Assessments using Visual Analog Score for GI symptoms which including pain, nausea, bloating, vomiting.
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Every 15 minutes during CRH/placebo infusion for 4 hours
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The effect of CRH on salivary cortisol level
Délai: Right before CRH/placebo injection, 15, 30, 60, 120 minutes after injection
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Salivary cortisol level in nmol/L during placebo or CRH infusion
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Right before CRH/placebo injection, 15, 30, 60, 120 minutes after injection
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- S65020
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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produit fabriqué et exporté des États-Unis.
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