Laxative Bowel Cleansing SolutionsNCT02642783
Sensory Properties of Bowel Cleansing Solutions
A study testing Descriptive analysis and acceptability test in people with Laxative Bowel Cleansing Solutions, run by American University of Beirut Medical Center.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Laxative Bowel Cleansing Solutions
- What is being tested?
- Descriptive analysis and acceptability test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between 18 and 50 years
Who cannot join
- allergies to polyethelene glycol (PEG), artificial sweeteners
About this study
Official title: Sensory Evaluation of Laxative Bowel Solutions Used Prior to Colonoscopy
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.
- Conditions
- Laxative Bowel Cleansing Solutions
- Being tested
- Descriptive analysis, acceptability test
- Keywords
- laxatives, sensory evaluation, acceptability, colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Descriptive analysisBehavioural
subjects were asked to assess the sensory profile by tasting the laxative bowel cleansing solutions, namely: Moviprep, picoprep, fortrans and isinova
acceptability testBehavioural
subjects were asked to assess the acceptability of the laxative bowel cleansing solutions, namely: Moviprep, picoprep, fortrans and isinova
| Study group | Role | What they receive |
|---|---|---|
| Descriptive analysis | Other | panelists were asked to rate different sensory attributes for different laxative bowel cleansing solutions on a 15 cm line scale. Receives: 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. Receives: Behavioral: acceptability test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
Secondary outcomes (2)
Acceptability Score
untrained participants evaluated the laxative samples for acceptability testing using the 9-point hedonic scale.
Measured: 1 week
Just about right score
Participants evaluated the laxative samples for the 4 basic tastes (saltiness, sourness, sweetness and bitterness) to determine their compatibility with optimum taste levels in the products.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laxative Bowel Cleansing SolutionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ammar Olabi, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02642783
- Sponsor's protocol ID
- NUT.AO.19
- Status last verified
- Dec 2015
- First submitted
- 22 Dec 2015
- Last updated
- 30 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Evaluation of Laxative Bowel Solutions Used Prior to Colonoscopy
- ClinicalTrials.gov ID
- NCT02642783
- Acronym / sponsor ID
- NUT.AO.19
- Conditions
- Laxative Bowel Cleansing Solutions
- Keywords
- laxatives, sensory evaluation, acceptability, colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Descriptive analysis | Other | Behavioral: Descriptive analysispanelists were asked to rate different sensory attributes for different laxative bowel cleansing solutions on a 15 cm line scale. |
| Acceptability test | Other | Behavioral: acceptability testpanelists were asked to rate the acceptability of different laxative bowel cleansing solutions using the 9-point hedonic scale. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- age between 18 and 50 years
Key exclusion criteria (1 listed)
- allergies to polyethelene glycol (PEG), artificial sweeteners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Descriptive analysissubjects were asked to assess the sensory profile by tasting the laxative bowel cleansing solutions, namely: Moviprep, picoprep, fortrans and isinova | Behavioural | Descriptive analysis |
| acceptability testsubjects were asked to assess the acceptability of the laxative bowel cleansing solutions, namely: Moviprep, picoprep, fortrans and isinova | Behavioural | Acceptability test |
Primary outcome
rating of sensory attributes
Time frame: 3 weeks
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.
2 secondary outcomes
Acceptability Score
Time frame: 1 week
Just about right score
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2015.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Descriptive analysis and acceptability test in people with Laxative Bowel Cleansing Solutions, run by American University of Beirut Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rating of sensory attributes (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2015; AzTrials last refreshed its copy on 6 Nov 2026.