Status:
COMPLETED
Neuro-immune Interactions and PPI
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Functional Dyspepsia
Eligibility:
All Genders
18-64 years
Phase:
PHASE4
Brief Summary
Prospective interventional study on duodenal neuro-immune interactions in healthy volunteers and functional dyspepsia patients and the effects of PPI
Detailed Description
Duodenal low-grade inflammation is frequently reported in functional dyspepsia (FD), while also neuronal and structural changes in duodenal submucosal ganglia have been described in FD patients. Proto...
Eligibility Criteria
Inclusion
- Patients with FD diagnosis as per Rome IV criteria (EPS or PDS).
- Normal investigation including upper GI endoscopy.
- Patients have confirmed duodenal mucosal eosinophilia.
- Patients witnessed written informed consent.
- Patients aged between 18 and 64 years inclusive.
- Male or female (not pregnant or lactating and using contraception or postmenopausal).
- Subjects are capable to understand the study and the questionnaires, and to comply with the study requirements.
Exclusion
- Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study.
- Patients with any major psychiatric disorders (stable dose of single antidepressant allowed for psychiatric indication, no limitation for other indications).
- Patients presenting with predominant symptoms of irritable bowel syndrome (IBS) or of gastro-esophageal reflux disease (GERD).
- Patients with personal or family (first-degree relative) of diabetes mellitus, celiac disease, inflammatory bowel disease, psoriasis, lupus, scleroderma, rheumatic or other systemic auto-immune disease.
- Patients with eosinophilic esophagitis or eosinophilic gastroenteritis.
- Active H. pylori infection (or \<6 months after eradication).
- Allergy or atopy, including therapy.
- Organic gastro-intestinal disease or history of gastrointestinal surgery other than appendectomy or splenectomy.
- Known impaired liver or kidney dysfunction, or coagulation disorders.
- Known HIV, HBV or HCV infection, including therapy.
- Active coronary or peripheral artery disease.
- Use of anti-inflammatory drugs or anti-allergy drugs \<2 weeks before sampling.
- Use of immunosuppressants, antibiotics or acid-suppressive drugs \<3 months before sampling.
- Use of prokinetics \<2 weeks before sampling (unless if ≤3/week).
- Significant alcohol use (\>10 units/week).
- Any use of alcohol or smoking \<2 days before sampling.
- Active malignancy, including therapy.
- Females who are pregnant or lactating.
- Patients not capable to understand or be compliant with the study.
Key Trial Info
Start Date :
March 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04713969
Start Date
March 31 2021
End Date
September 23 2024
Last Update
January 28 2025
Active Locations (1)
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1
KU Leuven
Leuven, Belgie, Belgium, 3000