OBJECTIVES: As with colonoscopy, adequate bowel cleansing is essential prior to colon capsule endoscopy (CCE). Because CCE requires that the capsule traverse the entire gastrointestinal tract during the examination, laxative 'boosters' are used. The objective of this prospective, single-center, single-arm study was to evaluate the safety of a bowel preparation consisting of @entity968 ( @entity970 ) plus an oral @entity597 solution. METHODS: Subjects were healthy volunteers aged 50-75 years old with normal baseline serum chemistry. The bowel preparation consisted of 4 Senna tablets, 4 liters of @entity970 (split dose), 10 mg @entity1769 , 2 oral @entity597 solution boosters (6 oz. and 3 oz.), and 10 mg @entity15021 . Serum chemistry was performed at baseline, following @entity970 intake, 24 hours after @entity15021 administration, and at 7 days post procedure (in subjects with abnormal 24 hour results). The primary endpoints were the percentage of subjects with a clinically significant change in serum chemistry at the last test and the adverse event (AE) rate. RESULTS: A total of 25 subjects were enrolled. The serum chemistry was normal in all subjects at the final evaluation. One subject showed a slight elevation in @entity1011 (1.08 mg/dl 7 days post procedure from 0.84 mg/dl at baseline), deemed not clinically significant. Another subject had a transient elevation in serum @entity1011 (from 1.01 mg/dl at baseline to 1.45 mg/dl at 24 hours after the bowel preparation); values returned to near baseline at 7 days post procedure (1.06 mg/dl). There were no serious AEs, three moderate AEs related to the bowel preparation ( @entity390 , @entity10 , elevated @entity1011 ) and two mild unrelated AEs (chills, abdominal cramping). CONCLUSIONS: A bowel cleansing regimen of @entity970 plus an oral @entity597 solution can be used in healthy volunteers. These data provide support for the continued study of this regimen in future CCE clinical trials and in medical practice.

XXXX plus an oral @entity597 solution as a bowel cleansing regimen for colon capsule endoscopy: a prospective, single-arm study in healthy volunteers.

@entity390 :: ('MESH:D009325', 'Disease') :: ['nausea'] @entity15021 :: ('MESH:D001726', 'Chemical') :: ['bisacodyl'] @entity1769 :: ('MESH:D008787', 'Chemical') :: ['metoclopramide'] @entity1011 :: ('MESH:D003404', 'Chemical') :: ['creatinine'] @entity10 :: ('MESH:D006261', 'Disease') :: ['headache'] @entity970 :: ('CHEBI:46793', 'Chemical') :: ['PEG'] @entity968 :: ('MESH:D011092', 'Chemical') :: ['polyethylene glycol'] @entity597 :: ('CHEBI:16189', 'Chemical') :: ['sulfate']
@entity968 :: (MESH:D011092,Chemical) :: ['Polyethylene glycol']
