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Trial record 17 of 41 for:    Recruiting, Not yet recruiting, Available Studies | Dyspepsia

Effect of Sporebiotics in FD

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ClinicalTrials.gov Identifier: NCT04030780
Recruitment Status : Recruiting
First Posted : July 24, 2019
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
MY HEALTH
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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.

Condition or disease Intervention/treatment Phase
Dyspepsia Dysbiosis Dietary Supplement: spore-forming probiotic Other: Placebo Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized placebo-controlled study in 2 parallel FD cohorts
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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)
Primary Purpose: Treatment
Official Title: Effect of Spore-forming Probiotics in Functional Dyspepsia Patients: a Randomized Placebo-controlled Trial
Actual Study Start Date : June 3, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arm Intervention/treatment
Active Comparator: Cohort 1FD (on-PPI+sporebiotics)
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
spore-forming probiotic administered as 1 capsule twice daily (2,5 x 109 CFU per capsule) during 8 weeks

Placebo Comparator: Cohort 1FD (on-PPI+placebo)
study procedures at inclusion (1) and after 8 weeks on-PPI+ placebo (2) followed by 8 weeks on-PPI+ sporebiotics (open label)
Other: Placebo
similar capsules administered twice daily

Active Comparator: Cohort 2FD (off-PPI+sporebiotics)
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
spore-forming probiotic administered as 1 capsule twice daily (2,5 x 109 CFU per capsule) during 8 weeks

Placebo Comparator: Cohort 2FD (off-PPI+placebo)
study procedures at inclusion (1) and after 8 weeks of placebo (2) followed by 8 weeks of sporebiotics (open label)
Other: Placebo
similar capsules administered twice daily




Primary Outcome Measures :
  1. Clinical symptoms on sporebiotics vs. placebo and changes within-groups [ Time Frame: 8 weeks ]

    Change in Leuven Postprandial Distress Scale (LPDS) on sporebiotics vs. placebo and within-groups.

    LPDS is a daily diary assessing the severity of 11 upper gastrointestinal symptoms scored from 0 (none) to 4 (very severe) of which the total value is calculated (ranging from 0 to 44) with higher scores representing worse outcomes.

    A minimum clinically important difference of 0.7 for the cardinal FD symptoms (average of first 3 questions) will be used as a cut-off to determine clinical response to sporebiotics by comparing pretreatment scores with the average score during the last week on treatment.



Secondary Outcome Measures :
  1. Change in symptoms on sporebiotics vs. placebo and changes within-groups [ Time Frame: 8 weeks ]

    Change in Leuven Postprandial Distress Scale (LPDS) on sporebiotics vs. placebo and within-groups.

    LPDS is a daily diary assessing the severity of 11 upper gastrointestinal symptoms scored from 0 (none) to 4 (very severe) of which the total value is calculated (ranging from 0 to 44) with higher scores representing worse outcomes.

    A minimum clinically important difference of 0.5 for the cardinal FD (average of first 3 questions) and all symptoms by comparing pretreatment scores with the average score during the last week on treatment.


  2. Change in high-sensitivity C-reactive protein (hs-CRP) on sporebiotics vs. placebo and changes within-groups [ Time Frame: 8 weeks ]
    Change in hs-CRP (mg/L) sporebiotics vs. placebo and within-group by comparing pre- with post-treatment values.

  3. Change in proportion of gut homing-lymphocytes on sporebiotics vs. placebo and changes within-groups [ Time Frame: 8 weeks ]
    Change in proportion of gut homing-lymphocytes (measured by flow-cytometry) on sporebiotics vs. placebo and changes within-groups by comparing pre- with post-treatment values.

  4. Change in lipopolysaccharide-binding protein (LBP) on sporebiotics vs. placebo and changes within-groups [ Time Frame: 8 weeks ]
    Change in LBP (ng/mL) on sporebiotics vs. placebo and changes within-groups by comparing pre- with post-treatment values.

  5. Change in blood cholesterol on sporebiotics vs. placebo and changes within-groups [ Time Frame: 8 weeks ]
    Change in cholesterol (mg/dl) on sporebiotics vs. placebo and changes within-groups by comparing pre- with post-treatment values.

  6. Change in blood triglycerides on sporebiotics vs. placebo and changes within-groups [ Time Frame: 8 weeks ]
    Change in triglycerides (mg/dl) on sporebiotics vs. placebo and changes within-groups by comparing pre- with post-treatment values.

  7. Change in blood glucose on sporebiotics vs. placebo and changes within-groups [ Time Frame: 8 weeks ]
    Change in glucose (mg/dl) on sporebiotics vs. placebo and changes within-groups by comparing pre- with post-treatment values.

  8. Change in blood insulin on sporebiotics vs. placebo and changes within-groups [ Time Frame: 8 weeks ]
    Change in insulin (pmol/l) on sporebiotics vs. placebo and changes within-groups by comparing pre- with post-treatment values.

  9. Change in salivary cortisol on sporebiotics vs. placebo and changes within-groups [ Time Frame: 8 weeks ]
    Change in salivary cortisol (ng/ml) on sporebiotics vs. placebo and changes within-groups by comparing pre- with post-treatment values.

  10. Change in salivary secretory immunoglobulin A on sporebiotics vs. placebo and changes within-groups [ Time Frame: 8 weeks ]
    Change in salivary secretory immunoglobulin A (µg/ml) on sporebiotics vs. placebo and changes within-groups by comparing pre- with post-treatment values.

  11. Change in stool microbiota on sporebiotics vs. placebo and changes within-groups [ Time Frame: 8 weeks ]
    Change in stool microbiota (quantitative microbiota profiles) on sporebiotics vs. placebo and changes within-groups by comparing pre- with post-treatment values.

  12. Change in fecal short-chain fatty acids on sporebiotics vs. placebo and changes within-groups [ Time Frame: 8 weeks ]
    Change in fecal short-chain fatty acids (SCFA) on sporebiotics vs. placebo and changes within-groups by comparing pre- with post-treatment values.

  13. Change in fecal secretory immunoglobulin A on sporebiotics vs. placebo and changes within-groups [ Time Frame: 8 weeks ]
    Change in fecal secretory immunoglobulin A (sIgA) on sporebiotics vs. placebo and changes within-groups by comparing pre- with post-treatment values.

  14. Change in 14C-glycocholic acid breath test on sporebiotics vs. placebo and within-groups in patients with concomitant proton-pump inhibitors (PPI) [ Time Frame: 8 weeks ]
    Change in 14C-glycocholic acid breath test on sporebiotics vs. placebo and within-groups by comparing pre- with post-treatment values in patients with concomitant PPI



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04030780


Contacts
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Contact: Lucas Wauters, BSc +3216345238 lucas.wauters@kuleuven.be
Contact: Tim Vanuytsel +3216341973 Tim.vanuytsel@kuleuven.be

Locations
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Belgium
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Lucas Wauters, MD    003216342538    lucas.wauters@kuleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
MY HEALTH
Investigators
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Principal Investigator: Tim Vanuytsel Universitaire Ziekenhuizen Leuven

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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT04030780     History of Changes
Other Study ID Numbers: S62043
First Posted: July 24, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitaire Ziekenhuizen Leuven:
spore-forming probiotic
sporebiotic
proton pump inhibitor
dyspepsia
Additional relevant MeSH terms:
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Dyspepsia
Dysbiosis
Signs and Symptoms, Digestive
Signs and Symptoms
Pathologic Processes