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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04588623
Other study ID # 32-347 ex 19/20
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 25, 2020
Est. completion date March 14, 2023

Study information

Verified date March 2023
Source Medical University of Graz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main purpose of this study is to validate the positive effect of "Omnibiotic Stress Repair" on patients with active psoriatic Arthritis.


Description:

This is a single center, double blind (patients and investigators), Placebo controlled randomized trial. Consecutive patients with Psoriatic Arthritis (PsA) in moderate disease activity (Psoriatic Arthritis Disease Activity Score: PASDAS >3.2 - <5.4) on a stable treatment (no immunomodulatory treatment change in the last 3 months) with biological (bDMARDs) and/or synthetic disease modifying anti-rheumatic drugs (sDMARDs) and/or glucocorticoids will be included in the study. Clinical assessment will be scheduled at baseline, 12 weeks and 24 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date March 14, 2023
Est. primary completion date January 12, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 89 Years
Eligibility Inclusion Criteria: 1. Male or female patient =18 years and <90 years of age 2. PsA according to CASPAR criteria 3. MoDA defined by a PASDAS >3.2 - <5.4 4. Stable immunomodulatory therapy for the last 12 weeks before baseline (no change in bDMARD/sDMARD/glucocorticoid treatment) 5. Written informed consent Exclusion Criteria: 1. History of bariatric surgery 2. Prior use of probiotics in the last 24 weeks 3. Use of probiotics, other than the study product, during the study period. 4. Antibiotic therapy within the last 4 weeks before inclusion 5. Inflammatory bowel disease 6. Recent (less than 12 weeks) acute myocardial infarction or decompensated heart failure 7. Recent (less than 12 weeks) stroke 8. Known malignancy 9. Inability of the patient to follow the treatment protocol 10. Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Omnibiotic Stress Repair (OBSR)
OBSR is given orally once daily (3g) for 3 months
Other:
Placebo
Placebo is given orally once daily (3g) for 3 months

Locations

Country Name City State
Austria Medical University of Graz Graz Styria

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effect on disease activity according to PASDAS categories To test differences in response according to the Psoriatic Disease Activity Score (PASDAS, range 0-10, higher values indicate higher disease activity) after 3 months of intake of OBSR compared to placebo in PsA patients.
Difference in response is defined by the different amount of patients shifting from moderate disease activity (PASDAS > 3.2 - < 5.4) to low disease activity or remission (PASDAS = 3.2) in the two groups.
3 months
Secondary Effect on disease activity according to PASDAS score To test differences in disease activity according to the Psoriatic Disease Activity Score (PASDAS, range 0-10, higher values indicate higher disease activity) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months. 3 and 6 months
Secondary Effect on disease activity according to PASDAS categories independent of concomitant medication To test differences in response according to the Psoriatic Disease Activity Score (PASDAS, range 0-10, higher values indicate higher disease activity) after 3 months of intake of OBSR compared to placebo in PsA patients independent of the concomitant medication. For this analysis a logistic regression analysis will be performed using response as dependent and concomitant medication and OBSR/Placebo as indipendent variables. 3 months
Secondary Longterm effect on disease activity according to PASDAS categories To test differences in response according to the Psoriatic Disease Activity Score (PASDAS, range 0-10, higher values indicate higher disease activity) before and after probiotic intake at 3 and 6 months.
Difference in response is defined by the different amount of patients shifting from moderate disease activity (PASDAS > 3.2 - < 5.4) to low disease activity or remission (PASDAS = 3.2) in the two groups.
3 and 6 months
Secondary Impact of disease according to the PSAID-12 To assess differences in disease impact according to the Psoriatic Arthritis Impact of Disease Score - 12 (PSAID-12, range 0-10, higher values indicating worse status) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months. 3 and 6 months
Secondary Impact of disease according to the TJC To assess differences in disease impact according to the Tender joint count (TJC, range 0-68, higher values indicating worse status) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months. 3 and 6 months
Secondary Impact of disease according to the SJC To assess differences in disease impact according to the Tender joint count (SJC, range 0-66, higher values indicating worse status) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months. 3 and 6 months
Secondary Pain assessed by PtPain VAS To assess differences in pain measured by the patient pain visual analogue scale (Pt-VAS, range 0-10, higher values indicating worse status) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months. 3 and 6 months
Secondary Enthesitis assessed by the LEI To assess differences in enthesitis according to the leeds enthesitis index (LEI, range 0-6, higher values indicating worse status) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months. 3 and 6 months
Secondary Dactylitis assessed by the DS To assess differences in dactylitis according to the dactylitis score (DS, range 0-20, higher values indicating worse status) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months. 3 and 6 months
Secondary Impact of disease according to the PGA To assess differences in disease impact according to the Patient global assessment (PGA, range 0-10, higher values indicating worse status) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months. 3 and 6 months
Secondary Impact of disease according to the EGA To assess differences in physician's disease assessment according to the Evaluator global assessment (EGA, range 0-10, higher values indicating worse status) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months. 3 and 6 months
Secondary Impact of disease according to the SF-36 To assess differences in disease impact according to the Short form health survey 36 (SF-36, Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months. 3 and 6 months
Secondary Dietary assessment according to the Diet-Questionnaire To assess differences in diet according to the Diet-Questionnaire (15 questions on the type of diet and amount of food intake. Results will be depicted in a descriptive manner) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months. 3 and 6 months
Secondary Skin involvement according to the PASI To assess differences in skin involvement according to the Psoriasis Area and Severity Index (PASI, range 0-72, higher values indicating worse skin involvement) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months. 3 and 6 months
Secondary Impact of skin involvement according to the DLQI To assess differences in quality of life due to skin involvement according to the Dermatology Life Quality Index (DLQI, range 0-30, higher values indicating worse quality of life) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months. 3 and 6 months
Secondary Impact of disease according to the HAQ To assess differences in disease impact according to the Health Assessment Questionnaire (HAQ, range 0-3, higher values indicating worse status) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months. 3 and 6 months
Secondary Fatigue assessment accoring to the FACIT To assess differences in fatigue according to the functional assessment of chronic illness therapy for fatigue (FACIT, range 0-52, higher values indicating worse fatigue) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months. 3 and 6 months
Secondary Hospital anxietey and depression assessment according to the HADS To assess differences in hospital anxietey and depression according to the Hospital Anxiety and Depression Scale (HADS, range 0-21, higher values indicating worse status) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months. 3 and 6 months
Secondary Laboratory inflammation assessment according to ESR To assess differences in disease impact according to the Erythrocyte sedimentation rate (ESR, mm, higher values indicating worse status) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months. 3 and 6 months
Secondary Laboratory inflammation assessment according to CRP To assess differences in laboratory inflammation according to the C-reactive protein (CRP, mg/L. Higher values indicating worse status) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months. 3 and 6 months
Secondary Change in gut microbiota To assess differences in gut microbiota composition (according to 16S rRNA targeted Amplicon Sequencing (%), displayed descriptively) before and after probiotic intake and between the OBSR and placebo control before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months. 3 and 6 months
Secondary Gut permeability according to Zonulin To assess differences in gut permeability according to stool Zonulin (ELISA, ng/ml, values above 55 indicate higher permeability) before and after probiotic intake and between the OBSR and placebo control before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months. 3 and 6 months
Secondary Gut inflammation according to Calprotectin To assess differences in gut inflammation according to stool Calprotectin (ELISA, mg/l, values above 50 indicate inflammation) before and after probiotic intake and between the OBSR and placebo control before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months. 3 and 6 months
Secondary Neutrophile function according to Phagocytosis assessment To assess differences in neutrophile function according to Phagocytosis assessment (Phagotest, normal values 95-99%, lower values indicate less function, Phagoburst, normal values 97-100% (E.coli stimulus), 1-10% (fMLP stimulus), 98-100% (PMA stimulus) before and after probiotic intake and between the OBSR and placebo control before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months. 3 and 6 months
Secondary Inflammation assessment according to cytokine Level To assess differences in cytokine levels in blood and synovial fluid (Interleukin (IL) pg/ml with normal ranges: IL-1 (<238), IL-5 (<19.27), IL-6 (<7.0), IL-8 (<10.59), IL-10 (<10.05), IL-17A (<11.14), IL-18 (37.43), IFN Alpha (<1.80), IFN Gamma (<6.82), TNF Alpha (<18.88)) before and after probiotic intake and between the OBSR and placebo control before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months. 3 and 6 months
Secondary Lymphocyte subtypes according to FACS To assess differences in lymphocyte subtypes according to fluorescence activated cell sorting (FACS, %) before and after probiotic intake and between the OBSR and placebo control before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months. 3 and 6 months
Secondary Metabolic assessment using NMR To assess metabolomic differences in stool, serum and synovial fluid using nuclear magnetic resonance (NMR metabolic profiling, results are shown in a descriptive manner) before and after probiotic intake and between the OBSR and placebo control before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months. 3 and 6 months
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