Table 1.
Activity/assessment | Prestudy screening | Visit 1 Baseline |
Weeks 1, 2 and 3 |
Visit 2 1 month |
Visit 3 3 months |
Visit 4 6 months |
Patients | n = ? | n=80 | n=all | n=all | n=all | n=all |
Screening log | x | |||||
Inclusion/exclusion form | x | |||||
Consent form | x | |||||
Randomisation | x | |||||
Study-composed questionnaire | x | x | x | x | x | |
Patient global (VAS 0– 100 mm) | x | x | x | x | x | |
Patient fatigue (VAS 0–100 mm) | x | x | x | x | x | |
Patient pain (VAS 0–100 mm) | x | x | x | x | x | |
HAQ | x | x | x | x | x | |
BASDAI | x | x | x | |||
BASFAI | x | x | x | |||
DLQI | x | x | x | x | x | |
Gastrointestinal symptom diary | x | x | x | x | x | |
Eating habits questionnaire | x | |||||
Clinical examination | ||||||
Height (m) | x | |||||
Weight (kg) | x | x | x | |||
Blood pressure (mm Hg) | x | x | x | |||
Psoriasis Area Severity Index | x | x | x | |||
SPARCC Enthesitis Score | x | x | x | |||
Swollen joint count (66) | x | x | x | |||
Tender joint count (68) | x | x | x | |||
Doctors global (VAS 0–100 mm) | x | x | x | |||
BASMI | x | x | x | |||
Tender point count | x | x | x | |||
Interview (AEs) | x | x | x | |||
Blood sample analysis | ||||||
C reactive protein (mg/L) | x | x | x | x | ||
Orosomucoid (g/L) | x | x | x | x | ||
Calprotectin | x | x | x | x | ||
1,25-Dihydroxyvitamin D (nmol/L) | x | x | x | x | ||
TSH (mIU/L) | x | x | ||||
Hgb (mmol/L) | x | x | ||||
Triglyceride (mmol/L) | x | x | ||||
LDL-cholesterol (mmol/L) | x | x | ||||
HDL-cholesterol (mmol/L) | x | x | ||||
Total cholesterol (mmol/L) | x | x | ||||
Haemoglobin A1c (mmol/mol) | x | x | ||||
HLA-B27 status (±) | x | |||||
Serology tests for Yersinia, Campylobacter, Salmonella (±) | x | |||||
Faecal calprotectin | x | x | x | x | ||
Faecal microbiota analysis | x | x | x | x | ||
Sigmoidoscopy and mucosa biopsy | x | x | ||||
Stool, blood and urine samples (biobank) | x | x | x | x | ||
Intestinal permeability test | x | x | ||||
Intervention (±FMT) | x | |||||
Serious AE forms | x |
AE, adverse event; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI; Bath Ankylosing Spondylitis Functional Index; BASMI, Bath Ankylosing Spondylitis Metrology index; DLQI, Dermatology Quality of Life Index; HAQ, Health Assessment Questionnaire; HDL, high-density lipoprotein; Hgb, haemoglobin; LDL, low-density lipoprotein; SPARCC, Spondyloarthritis Research Consortium of Canada; TSH, thyroid-stimulating hormone; VAS, visual analogue scale.