Table 1

Protocol schedule of forms and procedures.

Activity/assessmentPrestudy screeningVisit 1
Baseline
Weeks
1, 2 and 3
Visit 2
1 month
Visit 3
3 months
Visit 4
6 months
Patientsn = ?n=80n=alln=alln=alln=all
Screening logx
Inclusion/exclusion formx
Consent formx
Randomisationx
Study-composed questionnairexxxxx
Patient global (VAS 0– 100 mm)xxxxx
Patient fatigue (VAS 0–100 mm)xxxxx
Patient pain (VAS 0–100 mm)xxxxx
HAQxxxxx
BASDAIxxx
BASFAIxxx
DLQIxxxxx
Gastrointestinal symptom diaryxxxxx
Eating habits questionnairex
Clinical examination
 Height (m)x
 Weight (kg)xxx
 Blood pressure (mm Hg)xxx
 Psoriasis Area Severity Indexxxx
 SPARCC Enthesitis Scorexxx
 Swollen joint count (66)xxx
 Tender joint count (68)xxx
 Doctors global (VAS 0–100 mm)xxx
 BASMIxxx
 Tender point countxxx
Interview (AEs)xxx
Blood sample analysis
 C reactive protein (mg/L)xxxx
 Orosomucoid (g/L)xxxx
 Calprotectinxxxx
 1,25-Dihydroxyvitamin D (nmol/L)xxxx
 TSH (mIU/L)xx
 Hgb (mmol/L)xx
 Triglyceride (mmol/L)xx
 LDL-cholesterol (mmol/L)xx
 HDL-cholesterol (mmol/L)xx
 Total cholesterol (mmol/L)xx
 Haemoglobin A1c (mmol/mol)xx
 HLA-B27 status (±)x
 Serology tests for Yersinia, Campylobacter, Salmonella (±)x
Faecal calprotectinxxxx
Faecal microbiota analysisxxxx
Sigmoidoscopy and mucosa biopsyxx
Stool, blood and urine samples (biobank)xxxx
Intestinal permeability testxx
Intervention (±FMT)x
Serious AE formsx
  • 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.