NCT02642783

Brief Summary

Samples of 4 commercially available bowel cleansing solutions, namely PEG-electrolyte + ascorbic acid (PEG-Asc, Moviprep®, Norgine, UK), PEG-electrolyte (PEG, Fortrans® Ibsen, France), sodium picosulfate/magnesium citrate (SPS, Picoprep®, Ferring, Switzerland), and oral sodium sulfate (OSS, Izinova®, Ibsen, France) were prepared according to the manufacturer's instructions. Descriptive analysis was conducted with trained panelists (N= 14) to create a sensory profile for the solutions and generated attributes were rated on an unstructured 15-cm line scale using the Compusense at-hand® (Guelph, Canada) sensory evaluation software. Acceptability testing was carried out with untrained participants (N=80) and samples were rated on the 9-point hedonic scale. Moreover, a Just-About-Right (JAR) scale was included for the four basic tastes to determine their compatibility with optimum taste/acceptability levels in the products.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 30, 2015

Completed
Last Updated

December 30, 2015

Status Verified

December 1, 2015

Enrollment Period

1 month

First QC Date

December 22, 2015

Last Update Submit

December 29, 2015

Conditions

Keywords

laxativessensory evaluationacceptabilitycolonoscopy

Outcome Measures

Primary Outcomes (1)

  • rating of sensory attributes

    participants attended 4 training sessions during which they generated sensory descriptive attributes specific for the tasted laxative solutions. In addition, they evaluated the laxative samples by rating generated attributes on a 15-cm unstructured line scale using compusense at-hand sensory evaluation software.

    3 weeks

Secondary Outcomes (2)

  • Acceptability Score

    1 week

  • Just about right score

    1 week

Study Arms (2)

Descriptive analysis

OTHER

panelists were asked to rate different sensory attributes for different laxative bowel cleansing solutions on a 15 cm line scale.

Behavioral: Descriptive analysis

Acceptability test

OTHER

panelists were asked to rate the acceptability of different laxative bowel cleansing solutions using the 9-point hedonic scale.

Behavioral: acceptability test

Interventions

subjects were asked to assess the sensory profile by tasting the laxative bowel cleansing solutions, namely: Moviprep, picoprep, fortrans and isinova

Descriptive analysis

subjects were asked to assess the acceptability of the laxative bowel cleansing solutions, namely: Moviprep, picoprep, fortrans and isinova

Acceptability test

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age between 18 and 50 years

You may not qualify if:

  • allergies to polyethelene glycol (PEG), artificial sweeteners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 22, 2015

First Posted

December 30, 2015

Study Start

November 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 30, 2015

Record last verified: 2015-12

Data Sharing

IPD Sharing
Will not share