A CCEPTED MANUSCRIPT
and stenosis in order to quantify small bowel inflammatory change in one score 20 . This scoring
system uses specific definitions for each of the recorded parameters to reduce inter-reviewer
variability. In addition, we also counted red spots as observed during VCE.
For all VCE analyses (visit 2-7), data were recorded using the SB3 TM Pillcam video recording
capsule (Medtronic, Ireland). For all visits, subjects met fasting in the morning and the Pillcam
capsule was swallowed with water. Video images were recorded for a total of 8 hours during each
visit, after which the capsule was verified in the video to have passed the small intestine.
Four experienced gastroenterologists, blinded to intervention and not allowed to communicate
internally regarding obtained VCE data, reviewed the video material retrieved from the capsules
using the Pillcam TM Reader Software Version 9.0 from Medtronic. The VCE video material from all
6 VCE visits for each of the subjects were evaluated by two randomized reviewers, and mean
values for each subject visit were calculated. In cases where the data from a specific visit differed
MANUSCRIPT
with 4 or more number of ulcers, a third reviewer would review the VCE dataset. A mean value of
all 3 datasets was then calculated and used as the final data point for that specific visit. All VCE
reviews were performed prior to database lock and unmasking of the randomization key.
Representative pictures of the VCE material obtained are shown in Supplementary Figure 4.
Fecal samples and blood samples were obtained during all visits from visit 2 to visit 7 for secondary
and exploratory analyses.
At all visits, subjects completed the GI symptoms rating score (GSRS) questionnaire to assess GI
symptoms 21 .
Intestinal fatty acid binding protein (I-FABP) was measured by Nordic Biosite, Finland, in triplicate
heparin plasma samples using the HK406 human I-FABP ELISA kit from Hycult Biotech under
GLP conditions.
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