PPI and Microbiome in Healthy Volunteers and Functional Dyspepsia

NCT03545243 | Completed Phase 4

• 1 other identifier: S60984/60953
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective interventional study of the effect of PPI on the duodenal microbiome in healthy volunteers and functional dyspepsia patients

Conditions

Dysbiosis

Keywords

duodenum; microbiome; proton pump inhibitor

Outcome Measures

Primary Outcomes (1)

• Change in microbiota composition

  Change in microbiota composition in the duodenum (lumen and mucosa) and feces

  4 weeks

Secondary Outcomes (3)

• Change in mucosal inflammation

  4 weeks

• Change in mucosal permeability

  4 weeks

• Change in bile acid composition

  4 weeks

Study Arms (3)

Pantoprazole 40mg in healthy volunteers

OTHER

Peroral Pantoprazole 40mg once daily for 4 weeks

Drug: Pantoprazole 40mg

Pantoprazole 40mg in functional dyspepsia

OTHER

Peroral Pantoprazole 40mg once daily for 4 weeks

Drug: Pantoprazole 40mg

PPI-withdrawal in functional dyspepsia

OTHER

no PPI for 8 weeks

Other: PPI withdrawal

Interventions

Pantoprazole 40mg DRUG

Peroral Pantoprazole 40mg once daily during 28 days

Also known as: Pantomed

Pantoprazole 40mg in functional dyspepsia; Pantoprazole 40mg in healthy volunteers

PPI withdrawal OTHER

PPI withdrawal for 8 weeks

PPI-withdrawal in functional dyspepsia

Eligibility Criteria

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

You may qualify if:

• Subjects aged between 18 and 64 years inclusive
• Male or female (not pregnant or lactating and using contraception or postmenopausal)
• Normal bowel habits (defecation once every 3 days up to 3 times a day)
• Witnessed written informed consent
• Access to home freezer (-18 to -20°C)
• Capable to understand and comply with the study requirements

You may not qualify if:

• Active psychiatric symptoms (stable dose of single antidepressant allowed)
• Use of acid suppressive drugs (before starting Pantomed), immunosuppressants or antibiotics \<3 months before sampling
• Use of drugs influencing stool consistency, NSAIDs, anti-allergy drugs, bile acid sequestrants or ursodeoxycholic acid \<2 weeks before sampling
• Use of prokinetics \<2 weeks before sampling (unless if ≤3/week)
• History of major abdominal surgery, including cholecystectomy but not appendectomy or splenectomy
• Personal or family (first-degree relative) history of diabetes mellitus type 1, celiac disease, inflammatory bowel disease, psoriasis, rheumatic or other auto-immune diseases (including therapy)
• Allergy or atopy (eczema, asthma and/or allergic rhinoconjunctivitis) (including therapy)
• Kidney, liver or coagulation disorders
• Active coronary or peripheral artery disease
• Diabetes mellitus type 2 (including therapy)
• Active malignancy (including therapy)
• Known HIV, HBV or HCV infection (including therapy)
• Magnetizable objects (e.g. cochlear implants, neural stimulator, pacemaker, metal fragments or implants) or claustrophobia (MRI safety criteria with additional consent form, other procedures can still take place)
• Significant alcohol use (\>10 units/weeks)
• Any use of alcohol or smoking ≤2 days before sampling

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

• Wauters L, Ceulemans M, Frings D, Lambaerts M, Accarie A, Toth J, Mols R, Augustijns P, De Hertogh G, Van Oudenhove L, Tack J, Vanuytsel T. Proton Pump Inhibitors Reduce Duodenal Eosinophilia, Mast Cells, and Permeability in Patients With Functional Dyspepsia. Gastroenterology. 2021 Apr;160(5):1521-1531.e9. doi: 10.1053/j.gastro.2020.12.016. Epub 2020 Dec 18.

  PMID: 33346007 DERIVED

MeSH Terms

Conditions

Dysbiosis

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

  UZ 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: Prospective interventional study with study procedures at inclusion, after a baseline period of 4 weeks and Pantoprazole therapy for 4 weeks

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: June 4, 2018
• Study Start: April 23, 2018
• Primary Completion: March 8, 2020
• Study Completion: September 22, 2020
• Last Updated: September 28, 2020

Record last verified: 2020-09

Locations

BE (1)