Effect of Sporebiotics in FD

Effect of Spore-forming Probiotics in Functional Dyspepsia Patients: a Randomized Placebo-controlled Trial

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 acid suppression, compared to placebo.

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 weeks on-PPI+ sporebiotics or placebo (2) followed by 8 weeks on-PPI+ sporebiotics (open label)
• cohort 2FD (off-PPI): study procedures at inclusion (1) and after 8 weeks of sporebiotics or placebo (2) followed by 8 weeks of sporebiotics (open label)

Clinical outcomes and blood, saliva and stool parameters will be assessed at the beginning and end of each treatment period (week 0, 8 and 16) with additional questionnaires after 1 month (week 4 and 12).

Inclusion Criteria:

• 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 Criteria:

• 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)