Neuro-immune Interactions and PPI

• Status: Recruiting
• Trial end date: 2024-01-31
• Target enrollment: 0
• Participant gender: All

Summary

Prospective interventional study on duodenal neuro-immune interactions in healthy volunteers and functional dyspepsia patients and the effects of PPI

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universitaire Ziekenhuizen Leuven
• Treatments: Pantoprazole

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.