Effect of Sporebiotics in FD

NCT04030780 | Completed

• 1 other identifier: S62043
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspepsia; Dysbiosis

Keywords

spore-forming probiotic; sporebiotic; proton pump inhibitor; dyspepsia

Outcome Measures

Primary Outcomes (1)

• Proportion of clinical responders (first 8 weeks) in sporebiotics vs. placebo

  The Leuven Postprandial Distress Scale (LPDS) is a daily diary assessing the severity of 11 upper gastrointestinal symptoms scored from 0 (none) to 4 (very severe). A difference of 0.7 from baseline for the cardinal PDS symptoms (average of first 3 questions) will be used as a cut-off to determine clinical response by comparing averaged pre-treatment scores with the average score during the last week on treatment with sporebiotics vs. placebo. Only subjects with baseline score \>1 (mild) will be included in the intention-to-treat and per-protocol analysis.

  8 weeks

Secondary Outcomes (14)

• Proportion of minimal clinical responders (first 8 weeks) in sporebiotics vs. placebo

  8 weeks

• Change in weekly PDS symptoms from baseline (first 8 weeks) on sporebiotics vs. placebo and changes within-groups

  8 weeks

• Change in weekly EPS symptoms from baseline (first 8 weeks) on sporebiotics vs. placebo and changes within-groups

  8 weeks

• Change in weekly individual symptoms from baseline (first 8 weeks) on sporebiotics vs. placebo and changes within-groups

  8 weeks

• Proportion of (minimal) clinical responders (3 of the last 4 weeks of treatment) in sporebiotics vs. placebo

  8 weeks

Study Arms (4)

Cohort 1FD (on-PPI+sporebiotics)

ACTIVE COMPARATOR

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

Dietary Supplement: spore-forming probiotic

Cohort 1FD (on-PPI+placebo)

PLACEBO COMPARATOR

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

Other: Placebo

Cohort 2FD (off-PPI+sporebiotics)

ACTIVE COMPARATOR

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

Dietary Supplement: spore-forming probiotic

Cohort 2FD (off-PPI+placebo)

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

spore-forming probiotic DIETARY_SUPPLEMENT

spore-forming probiotic administered as 1 capsule twice daily (2,5 x 109 CFU per capsule) during 8 weeks

Cohort 1FD (on-PPI+sporebiotics); Cohort 2FD (off-PPI+sporebiotics)

Placebo OTHER

similar capsules administered twice daily

Cohort 1FD (on-PPI+placebo); Cohort 2FD (off-PPI+placebo)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• MY HEALTH: collaborator

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 34358486 DERIVED

MeSH Terms

Conditions

Dyspepsia; Dysbiosis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Tim Vanuytsel, MD PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: participants, care providers, investigators and outcomes assessor are blinded during the randomized placebo-controlled phase (8 weeks) but not during the open-label extension phase (8 weeks)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized placebo-controlled study in 2 parallel FD cohorts

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: July 24, 2019
• Study Start: June 3, 2019
• Primary Completion: July 7, 2020
• Study Completion: December 31, 2020
• Last Updated: February 16, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)