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Trial · Interventional

CompletedPhase 4Registry data

Effect of CRH on Duodenal Markers and Gastric Sensorimotor Function

Overview

Status
Completed
Phase
Phase 4
Enrollment
20 participants (actual)
Sponsor
Universitaire Ziekenhuizen KU Leuven · Other
Design
Randomized · Double masking
Countries
1 country

Belgium

Start
21 May 2021
Primary completion
19 Dec 2022
Completion
19 Dec 2022
First posted
8 Oct 2021
Last update posted
3 Jul 2024
Conditions
GI Motility Disorder

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202120222023
  1. Ph 4

    Effect of CRH on Duodenal Markers and Gastric Sensorimotor Function

    NCT05071781

    21 May 2021 to 19 Dec 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Corticotropin-release hormoneDrug
  • Corticotropin-release hormoneDrug

Arms2

  • Active comparator

    Cortisol releasing hormone group

    HVs will start with CRH infusion.

  • Placebo comparator

    Placebo (sodium choride) group

    HVs will start with NaCl 0.9% (placebo) infusion

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. The effect of corticotrophin release hormone (CRH) on duodenal mast cell count

    Time frame · 2 hours after CRH/placebo

    Registry description

    Duodenal mast cells (c-kit) will be counted per mm2 via stained duodenal biopsy sections.

  2. The effect of CRH on sensitivity to gastric distention (part 2)

    Time frame · 30 minutes after CRH/placebo

    Registry description

    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.

Secondary outcomes(6)
  1. The effect of CRH on duodenal eosinophilia

    Time frame · 2 hours after CRH/placebo

    Registry description

    Duodenal eosinophils (H\&E) will be counted per mm2 via stained duodenal biopsy sections.

  2. The effect of CRH on duodenal mucosal permeability

    Time frame · 2 hours after CRH/placebo

    Registry description

    Duodenal mucosa permeability on duodenal biopsies using adapted mini-Ussing chambers

  3. The effect of CRH on gastric emptying time

    Time frame · 30 minutes after CRH/placebo

    Registry description

    Gastric emptying time in minutes t (1/2) will be measured by 13C-octanoic acid breath test.

  4. The effect of CRH on gastric accommodation

    Time frame · 30 minutes after CRH/placebo

    Registry description

    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.

  5. The effect of CRH on gastroduodenal symptoms.

    Time frame · Every 15 minutes during CRH/placebo infusion for 4 hours

    Registry description

    Assessments using Visual Analog Score for GI symptoms which including pain, nausea, bloating, vomiting.

  6. The effect of CRH on salivary cortisol level

    Time frame · Right before CRH/placebo injection, 15, 30, 60, 120 minutes after injection

    Registry description

    Salivary cortisol level in nmol/L during placebo or CRH infusion

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 55 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Voluntary written informed consent of the participant has been obtained prior to any screening procedures 2. 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. 3. Healthy volunteers 4. Subjects aged 18-55 years old (55y included). 5. Male or female subjects. 6. Subjects who are capable to understand the study and the questionnaires, and to comply with the study requirements. Exclusion Criteria: 1. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol 2. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial 3. 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 4. Presence of a history of gastrointestinal surgery other than appendectomy 5. Presence of organic or functional gastrointestinal disease 6. Presence of gastro-intestinal symptoms 7. Major psychiatric disorder such as major depression 8. Presence of any disease affecting the gastrointestinal tract or hepatobiliary system. 9. History of allergic reaction to CRH 10. BMI equal to 30 mg/kg² or higher. 11. Use of drugs included in this list: 1. Opioids (unless short intake for acute pain and \> 1month ago) 2. Amitriptyline or mirtazapine; other antidepressants are allowed if the HV is on a stable dose and the drug is not combined with other antidepressants. 3. Corticosteroids 4. Antihistaminic drugs (last 2 weeks) 5. Proton pump inhibitors (last 2 weeks) 6. Disodiumchromoglycate or other mast cell stabilizers (last 2 weeks) 7. Leukotriene receptor antagonists (last 2 weeks) 8. NSAIDs (last 2 weeks) 9. Antibiotics (last 2 months) 10. Probiotics (last 2 weeks) 11. Other medication: to be discussed with physician

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