Once participants were randomised, the coordinating centre sent them sufficient treatment capsules for one year (and repeated yearly) in an appropriately labelled package.
This study was conducted according to the guidelines laid down in the Declaration of Helsinki and all procedures involving human subjects were approved by the King's College London (KCL) Research Ethics Committee and treatment capsules were approved by the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA).
In order to localize the point of inhibition and the molecular target of C7, we sought to determine the phenotypic consequences of C7 treatment on capsule biogenesis, and whether C7 treatment resulted in capsule release, intracellular accumulation of polymer, or inhibition of synthesis.
In limited HF treatment the capsule underwent chemical hydrolysis to generate oligosaccharide fragments, so unlike the fragments generated in MALDI-MS in the unprocessed capsule which were derived from gas-phase fragmentation, the HF-treated capsule produced peaks shifted up in mass by the addition of water (M = 792+18 = 810).
If the contracture is severe and is unresponsive to conventional treatments, joint capsule release surgery is an option [ 60].
The sample size was based on our estimation of the proportion of subjects that would be expected to exhibit mucosal breaks at post-treatment by capsule endoscopy.
The same starting dose of enzyme was used for both treatments: one capsule per day was administered to dogs <10 kg, divided over two meals, whilst 2 capsules/day (1 capsule per meal) was given to dogs >10 kg.
The number of mucosal breaks, reddened lesions and sites of bleeding in the small intestine found at baseline and post-treatment by capsule endoscopy was calculated for each subject and compared between Groups I and O.
During the first enrolment visit, patients from the 3 groups were given a 3-day treatment (two capsules every 6 h in the case of xyloglucan, three sachets/day in the case of diosmectite and 2 capsules/day in the case of S. bouliardii), with the first dose being administered at the time of recruitment (visit 1).
