Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03545243
Other study ID # S60984/60953
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 23, 2018
Est. completion date September 22, 2020

Study information

Verified date September 2020
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

PPIs are the first-line therapy in functional dyspepsia (FD) but frequently (over-)prescribed with potential adverse events, especially in the long term. As C. difficile and CAP are important causes of morbidity, mortality and healthcare costs, it is important to study the underlying mechanisms of PPI-induced dysbiosis.

In this prospective interventional study, study procedures will be performed at inclusion (1), after a baseline period of 4 weeks (2) and after treatment with Pantoprazole (Pantomed®) 40mg once daily during 4 weeks (3) in healthy volunteers and FD patients. In addition, study procedures will be performed at inclusion (1) and after PPI-withdrawal for 8 weeks in refractory FD patients.

The investigators aim to assess alterations of the duodenal (mucosa-associated and luminal) microbiome with PPI therapy and to correlate changes in the duodenal microbiota with oral and fecal microbiota, bile acids, intestinal permeability and histology and biochemical variables.

The results from this study will help to unravel the onset and extent of dysbiosis and provide additional arguments not to prescribe or continue PPI without clear clinical indications, especially in cases where alternative regimens may be available or the benefits of PPI are uncertain.


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date September 22, 2020
Est. primary completion date March 8, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- Females who are pregnant or lactating, who are not using contraception and premenopausal

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Pantoprazole 40mg
Peroral Pantoprazole 40mg once daily during 28 days
Other:
PPI withdrawal
PPI withdrawal for 8 weeks

Locations

Country Name City State
Belgium UZ Leuven Leuven

Sponsors (1)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in microbiota composition Change in microbiota composition in the duodenum (lumen and mucosa) and feces 4 weeks
Secondary Change in mucosal inflammation Change in mucosal inflammation (using immunohistochemistry) of the duodenum 4 weeks
Secondary Change in mucosal permeability Change in mucosal permeability (using ussing chambers) of the duodenum 4 weeks
Secondary Change in bile acid composition Change in bile acid composition in the duodenum 4 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05560087 - Association of PeRiODontal Disease and gUt Microbiome With Coronary artEry Disease (PRODUCE Study)
Recruiting NCT05288790 - Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT Phase 2
Completed NCT05575050 - Impact of Teeth Brushing in Ventilated COVID-19 Patients. N/A
Completed NCT06423586 - Effect of Lecithin-based Curcuma and Boswellia on Post-acute COVID-19 IBS N/A
Completed NCT04079218 - Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial Phase 4
Active, not recruiting NCT03554278 - Alteration of Stool Microbiota in Preterm Infants With Anemia
Completed NCT03659240 - Prebiotic Effects of a Polyphenol-rich Food Product N/A
Completed NCT04118049 - Vaginal Probiotics and Pessaries and Their Impact on the Vaginal Microenvironment N/A
Enrolling by invitation NCT06122636 - Efficacy of a Probiotic and Microbiological Analysis on Oral Complications Induced by Antineoplastic Therapies in Patients With HNC N/A
Recruiting NCT04200521 - The Effect of Bariatric Procedures on Gut Microbiota in Obese Individuals in United Arab Emirates and Lebanon
Completed NCT03523403 - Obesity-related Health Benefits of Apples N/A
Recruiting NCT05176535 - Determination of Vaginal Colonization and the Effect of an Oral Probiotic (PROSALVAG) N/A
Recruiting NCT06005298 - Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum: Application and Efficacy of SBIRT Intervention N/A
Completed NCT03675048 - Lactobacillus Reuteri DSM 17938 in Gut Microbiota Development in Infant Born by Caesarean Section N/A
Completed NCT03043300 - A Pilot Study Assessing Intestinal Microbiota Diversification and Changes After Travel to South(East) Asia From the US
Recruiting NCT05790564 - Almonds to Improve Gut Health and Decrease Inflammation N/A
Completed NCT04561284 - Carbohydrate-induced Resilience of the Gut Microbiome After Antibiotics Use N/A
Enrolling by invitation NCT04527055 - The Efficacy of 10-day and 14-day Bismuth-based Quadruple Therapy in First-line H. Pylori Eradication Phase 4
Recruiting NCT05622721 - REMBRANDT: REcovery of the MicroBiome fRom Antibiotics for Dental implanTs
Recruiting NCT05632497 - Alteration of Symbiosis Intestinal Microbiota on Patients With Anorexia Nervosa