Neuro-immune Interactions and PPI

NCT04713969 | Completed Phase 4

• 1 other identifier: S64807/64847
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Functional Dyspepsia

Keywords

inflammation; imaging

Outcome Measures

Primary Outcomes (1)

• The effect of PPI on duodenal mucosal inflammation (assessed by flow cytometry on lamina propria leukocytes) in FD

  Duodenal mucosal inflammation as assessed by flow cytometric quantification of immune cell populations in isolated lamina propria leukocytes before and after PPI

  4 weeks

Secondary Outcomes (4)

• The effect of PPI on symptoms (Patient Assessment of Upper Gastrointestinal Disorders - Symptom severity index [PAGI-SYM]) in FD

  4 weeks

• The effect of PPI on quality of life (Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life [PAGI-QOL]) in FD

  4 weeks

• The effect of PPI on salivary cortisol in FD

  4 weeks

• The effect of PPI on systemic inflammation (assessed by flow cytometry) in FD

  4 weeks

Other Outcomes (2)

• The effect of PPI on calcium transient amplitudes after electrical stimulation of submucosal neurons in FD

  4 weeks

• The effect of PPI on urine metabolites in FD

  4 weeks

Study Arms (2)

Functional dyspepsia patients before and after PPI

EXPERIMENTAL

Pantoprazole 40mg twice daily in functional dyspepsia patients for 4 weeks

Drug: Pantoprazole 40mg

Healthy controls without PPI

NO INTERVENTION

Baseline investigations

Interventions

Pantoprazole 40mg DRUG

Pantoprazole 40mg twice daily

Also known as: Pantomed

Functional dyspepsia patients before and after PPI

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

KU Leuven

Leuven, Belgie, 3000, Belgium

Location

MeSH Terms

Conditions

Inflammation

Interventions

Pantoprazole

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Tim Vanuytsel, MD PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention with PPI (Pantoprazole 40mg twice daily) in 30 FD patients. Baseline procedures in 30 healthy controls.

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: January 19, 2021
• Study Start: March 31, 2021
• Primary Completion: January 10, 2024
• Study Completion: September 23, 2024
• Last Updated: January 28, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)