Table 1.
Protocol schedule of forms and procedures.
| 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.