Clinical trial NCT04030780: Effect of Sporebiotics in FD
Official title: Effect of Spore-forming Probiotics in Functional Dyspepsia Patients: a Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyspepsia
Dysbiosis
Keywords: spore-forming probiotic
sporebiotic
proton pump inhibitor
dyspepsia
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: MY HEALTH
First posted: 2019-07-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized placebo-controlled study in 2 parallel FD cohorts
Primary purpose: TREATMENT

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 acid suppression, compared to placebo.

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 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).

Eligibility criteria: 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)

Primary outcomes:
measure: Proportion of clinical responders (first 8 weeks) in sporebiotics vs. placebo
timeFrame: 8 weeks
Secondary outcomes:
measure: Proportion of minimal clinical responders (first 8 weeks) in sporebiotics vs. placebo
timeFrame: 8 weeks
measure: Change in weekly PDS symptoms from baseline (first 8 weeks) on sporebiotics vs. placebo and changes within-groups
timeFrame: 8 weeks
measure: Change in weekly EPS symptoms from baseline (first 8 weeks) on sporebiotics vs. placebo and changes within-groups
timeFrame: 8 weeks
measure: Change in weekly individual symptoms from baseline (first 8 weeks) on sporebiotics vs. placebo and changes within-groups
timeFrame: 8 weeks
measure: Proportion of (minimal) clinical responders (3 of the last 4 weeks of treatment) in sporebiotics vs. placebo
timeFrame: 8 weeks
measure: Weekly (minimal) clinical responder rates in sporebiotics vs. placebo
timeFrame: 8 weeks
measure: Change in monthly PAGI-SYM score from baseline (first 8 weeks) on sporebiotics vs. placebo and changes within-groups
timeFrame: 8 weeks
measure: Change in monthly PAGI-QOL score from baseline (first 8 weeks) on sporebiotics vs. placebo and changes within-groups
timeFrame: 8 weeks
measure: Change in high-sensitivity C-reactive protein (hs-CRP) on sporebiotics vs. placebo and changes within-groups
timeFrame: 8 weeks
measure: Change in peripheral blood mononuclear cells on sporebiotics vs. placebo and changes within-groups
timeFrame: 8 weeks
measure: Change in plasma cytokines on sporebiotics vs. placebo and changes within-groups
timeFrame: 8 weeks
measure: Change in lipopolysaccharide-binding protein (LBP) on sporebiotics vs. placebo and changes within-groups
timeFrame: 8 weeks
measure: Change in stool microbiota on sporebiotics vs. placebo and changes within-groups
timeFrame: 8 weeks
measure: Safety of sporebiotics vs. placebo
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Tim Vanuytsel, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wauters L, Slaets H, De Paepe K, Ceulemans M, Wetzels S, Geboers K, Toth J, Thys W, Dybajlo R, Walgraeve D, Biessen E, Verbeke K, Tack J, Van de Wiele T, Hellings N, Vanuytsel T. Efficacy and safety of spore-forming probiotics in the treatment of functional dyspepsia: a pilot randomised, double-blind, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2021 Oct;6(10):784-792. doi: 10.1016/S2468-1253(21)00226-0. Epub 2021 Aug 3.