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Effect of Sporebiotics in FD

U

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Conditions

Dysbiosis
Dyspepsia

Treatments

Other: Placebo
Dietary Supplement: spore-forming probiotic

Study type

Interventional

Funder types

Other

Identifiers

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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