Status:
COMPLETED
Effect of Sporebiotics in FD
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
MY HEALTH
Conditions:
Dyspepsia
Dysbiosis
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
Single-site prospective interventional study aiming to demonstrate the effect of spore-forming probiotics on dyspeptic symptoms and blood, saliva and stool parameters in FD patients with and without a...
Detailed Description
Prospective randomized placebo-controlled study in 2 parallel FD cohorts (8 weeks) with open-label extension phase (8 weeks): * cohort 1FD (on-PPI): study procedures at inclusion (1) and after 8 week...
Eligibility Criteria
Inclusion
- Patients \>18 years with FD diagnosis (Rome IV criteria)
- 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
- Any active somatic or psychiatric condition that may explain dyspeptic symptoms (stable dose of single antidepressant allowed for psychiatric indication, no limitation for other indications)
- Predominant symptoms of gastro-esophageal reflux disease (GERD) or irritable bowel syndrome (IBS)
- Use of immunosuppressants or antibiotics \<3 months
- History of major abdominal surgery (except for appendectomy, cholecystectomy or splenectomy)
- Personal history of diabetes mellitus type 1, celiac disease or inflammatory bowel disease
- Diabetes mellitus type 2 (including therapy)
- Active malignancy (including therapy)
- Known HIV, HBV or HCV infection (including therapy)
- Significant alcohol use (\>10 units/weeks)
Key Trial Info
Start Date :
June 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04030780
Start Date
June 3 2019
End Date
December 31 2020
Last Update
February 16 2021
Active Locations (1)
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1
UZ Leuven
Leuven, Belgium, 3000