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

ABSTRACT: 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 polyethylene glycol (PEG) plus an oral sulfate 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 PEG (split dose), 10 mg metoclopramide, 2 oral sulfate solution boosters (6 oz. and 3 oz.), and 10 mg bisacodyl. Serum chemistry was performed at baseline, following PEG intake, 24 hours after bisacodyl 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 creatinine (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 creatinine (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 (nausea, headache, elevated creatinine) and two mild unrelated AEs (chills, abdominal cramping). CONCLUSIONS:A bowel cleansing regimen of PEG plus an oral sulfate 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.

SUBMITTER: Kashyap PK

PROVIDER: S-EPMC4530431 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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

Kashyap Pankaj K PK Peled Ravit R

Therapeutic advances in gastroenterology 20150901 5

<h4>Objectives</h4>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 polyethylene glycol (PEG) plus an oral sulfate solution.<h4>Methods</h4>Subjects were healthy volunteers aged 50-75 ...[more]

PMID: 26327914

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Project description:BackgroundSodium picosulfate⁄magnesium oxide⁄citric acid (Pico-Salax, Ferring Inc, Canada) is used widely in Canada and other countries for colon cleansing before colonoscopy. It is a low-volume osmotic⁄stimulant agent with the potential to deplete intravascular volume and alter electrolyte balance, yet there are little data regarding its effects on these clinically important end points.ObjectiveTo serially measure parameters of intravascular volume and electrolyte status in healthy volunteers over a 24 h period using the standard two-sachet dosing.MethodsTwenty volunteers were given one sachet of Pico-Salax at time 0 h and another sachet 5 h later, as per usual bowel cleansing protocol. Subjects were continually monitored during the first 12 h of the study with postural vital signs, serum electrolytes and electrocardiograms obtained at intervals throughout this initial period and again at 24 h postingestion.ResultsNo adverse events were reported nor were there any signs of intravascular volume depletion observed. There were decreases in potassium and calcium levels from baseline to 12 h, but these appeared minor and were corrected by 24 h. The proportions of patients with hypermagnesmia at 0 h, 5 h, 12 h and 24 h were 5%, 35%, 35% and 20%, respectively (P<0.05). However, the maximal values were only minimally elevated. Mean serum sodium, phosphate and creatinine levels remained within their respective reference ranges. There was a trend toward an increase in maximum corrected QT intervals from time 0 h (418 ms) to 5 h (430 ms) (P=0.06), but no significant change was seen subsequently at 12 h (419 ms). The subjects tolerated the medication well. The mean number of bowel movements per subject was 8.15 (range four to 15). Subjects consumed a mean (± SD) of 3.49±1.53 L of fluids during the observation period.ConclusionsThe proportion of individuals with hypokalemia, hypocalcemia and hypermagnesemia following two sachets of Pico-Salax is significant, but the magnitude of the changes was not clinically relevant in this relatively small group, and both calcium and potassium levels normalized at 24 h. Nonetheless, this could have implications in patients with pre-existing electrolyte abnormalities and the safety of dosing with more than two sachets.

Project description:BackgroundEfficient bowel cleansing is essential for a successful colonoscopy, but the ideal cleansing agent, volume, and pharmaceutical dosage form have yet to be determined. Small-volume cleansers enhance patient compliance.AimTo compare the bowel cleansing efficacy of 32-tablet sodium phosphate (Quiklean®) with 2-L polyethylene glycol (PEG)/bisacodyl (Klean-Prep/ Dulcolax®) under identical dietary recommendations.MethodsThis multicenter, randomized, parallel-group, noninferiority clinical trial enrolled 472 outpatients, randomized 456 subjects, and scheduled 442 subjects to undergo colonoscopy (Quiklean® = 222 and Klean-Prep/Dulcolax® = 220). After bowel preparation, a colonoscopist performed the colonoscopy with video recorded for rating. The primary efficacy endpoint was the bowel cleansing quality using the Aronchick Scale. The secondary endpoints were the bowel cleansing efficacy of three colon segments, tolerability and acceptability, safety using the Ottawa bowel preparation scale, questionnaires by subjects, and monitoring of adverse events.ResultsSuccess rates (Excellent + Good) of the bowel cleansing quality by Aronchick Scale were 98.6% (n = 205) and 97.6% (n = 204) in the Quiklean® and Klean-Prep/Dulcolax® groups, respectively. Quiklean® demonstrated noninferiority over Klean-Prep/Dulcolax® in colon cleansing efficacy. Quicken showed better tolerability and acceptability in the overall experience (was rated as excellent; 24.0% vs 17.2%; P = 0.0016) and the taste of the study preparation (was rated as excellent, 23.1% vs 13.4%; P < 0.0001) than Klean-Prep/Dulcolax®. Safety profiles did not differ between the two groups. Our data indicate that Quiklean® is an adequate, well-tolerated bowel cleansing preparation compared with the standard comparator Klean-Prep/Dulcolax®.ConclusionQuiklean® is sodium phosphate tablets available on Taiwan's market for bowel preparation; it potentially offers patients an alternative to standard large-volume bowel preparation regimens and may, therefore, increase positive attitudes toward colonoscopies and participation rates.

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

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

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