Effect of Sporebiotics in FD

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Dysbiosis; Dyspepsia

Treatments: Other: Placebo; Dietary Supplement: spore-forming probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT04030780

S62043

Details and patient eligibility

About

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.

Full 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 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).

Enrollment: 60 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 4 patient groups, including a placebo group

Cohort 1FD (on-PPI+sporebiotics)

Active Comparator group

Description:

study procedures at inclusion (1) and after 8 weeks on-PPI+ sporebiotics (2) followed by 8 weeks on-PPI+ sporebiotics (open label)

Treatment:

Dietary Supplement: spore-forming probiotic

Cohort 1FD (on-PPI+placebo)

Placebo Comparator group

Description:

study procedures at inclusion (1) and after 8 weeks on-PPI+ placebo (2) followed by 8 weeks on-PPI+ sporebiotics (open label)

Treatment:

Other: Placebo

Cohort 2FD (off-PPI+sporebiotics)

Active Comparator group

Description:

study procedures at inclusion (1) and after 8 weeks of sporebiotics (2) followed by 8 weeks of sporebiotics (open label)

Treatment:

Dietary Supplement: spore-forming probiotic

Cohort 2FD (off-PPI+placebo)

Placebo Comparator group

Description:

study procedures at inclusion (1) and after 8 weeks of placebo (2) followed by 8 weeks of sporebiotics (open label)

Treatment:

Other: Placebo