Duodenal Neuro-immune Interactions and Effects of PPI in Functional Dyspepsia

S64807/64847

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

2021-03-31

2024-01-31

2024-01-31

Recruiting

Early phase I

60

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intervention with PPI (Pantoprazole 40mg twice daily) in 30 FD patients. Baseline procedures in 30 healthy controls.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

2023-11-29