Patients on Long-term Proton Pump Inhibitor Therapy Clinical Trial
Official title:
Probiotic Modulation of Intestinal Microbiota in Long-term Intake of Proton Pump Inhibitors: Influence on Intestinal Inflammation and Digestion
Verified date | September 2022 |
Source | Medical University of Graz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Long-term proton pump inhibitor use has been linked to intestinal dysbiosis, inflammation and gastrointestinal symptoms. Probiotics has been shown to correct dysbiosis, reduce inflammation and strengthen the gut barrier. The aim of this study is to evaluate the influence of a three months intervention with a probiotic on intestinal inflammation, bowel symptoms, dysbiosis and gut permeability.
Status | Completed |
Enrollment | 57 |
Est. completion date | September 30, 2020 |
Est. primary completion date | July 17, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age >18 - willing to give written Informed Consent - PPI intake for at least 6 months Exclusion Criteria: - Active infections at time of inclusion - Antibiotic therapy within the last 14 days (includes prophylactic use) - Inflammatory bowel diseases - Consumption of pre/synbiotics other than the product provided during the trial - Concomitant diseases or other circumstances that suggest that the patients are not eligible for participation in the study |
Country | Name | City | State |
---|---|---|---|
Austria | Department of Internal Medicine, Medical University of Graz | Graz |
Lead Sponsor | Collaborator |
---|---|
Medical University of Graz |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in faecal calprotectin levels due to the intervention | Calprotectin levels are measured in ng/mg stool using enzyme linked immunosorbent assay (ELISA) at baseline, after 3 months of intervention and after further 3 months of follow up | 6 months | |
Secondary | changes in PPI associated Veillonella/Streptococcus dysbiosis index due to the intervention | relative abundance of bacteria in the gut microbiome will be assessed using 16S DNA sequencing, bacteria from the oral cavity will be especially investigated at baseline, after 3 months of intervention and after further 3 months of follow up | 6 months | |
Secondary | Changes in faecal zonulin levels due to the intervention | Zonulin levels are measured in ng/mg stool using enzyme linked immunosorbent assay (ELISA) at baseline, after 3 months of intervention and after further 3 months of follow up | 6 months | |
Secondary | Changes in serum endotoxin levels due to the intervention | endotoxin levels are measured in endotoxin units/ml serum using a cell based detection method at baseline, after 3 months of intervention and after further 3 months of follow up | 6 months | |
Secondary | Changes in serum lipopolysaccharide binding protein (LBP) levels due to the intervention | LBP levels are measured in µg/ml serum using ELISA at baseline, after 3 months of intervention and after further 3 months of follow up | 6 months | |
Secondary | Changes in serum sCD14 levels due to the intervention | sCD14 levels are measured in µg/ml serum using ELISA at baseline, after 3 months of intervention and after further 3 months of follow up | 6 months | |
Secondary | Changes in serum VitB12 levels due to the intervention | VitB12 levels are measured as part of the routine laboratory report at baseline, after 3 months of intervention and after further 3 months of follow up | 6 months | |
Secondary | Changes in health related quality of life due to the intervention | Quality of life will be described using the Short Form 36 Questionnaire at baseline, after 3 months of intervention and after further 3 months of follow up | 6 months | |
Secondary | Changes in gastrointestinal quality of life due to the intervention | gastrointestinal quality of life will be described using the GIQLI questionnaire according to Eyparsch at baseline, after 3 months of intervention and after further 3 months of follow up | 6 months | |
Secondary | Changes in nutritional behaviour due to the intervention | Changes in nutritional behaviour due to the intervention will be determined by a food frequency questionnaire at baseline, after 3 months of intervention and after further 3 months of follow up | 6 months |