ColonoscopyPEGNCT03358537
A Low-residue Diet vs Clear Liquid Diet as a Bowel Colonoscopy Preparation With Polyethylene Glycol (PEG)
A study testing Clear Liquid Diet and Low-residue Diet in people with Colonoscopy, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.
Trial summary
This was a randomized, endoscopists' blinded comparison of bowel colonoscopy cleansing and tolerability of a prespecified low-residue diet compared with a clear liquid diet and Polyethylene Glycol bowel preparation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Clear Liquid Diet and Low-residue Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Jun 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Out-patient scheduled for colonoscopy
Who cannot join
- Subjects under 18 years of age
- Pregnancy
- Subjects with decompensated metabolic, renal, cardiac and psychiatric disease
- Allergy to PEG
- Refuse participation
About this study
Official title: A Low-residue Diet is a Good Option for Patients With PEG Based Colon Preparation: a Randomized Clinical Trial
This was a randomized, endoscopists' blinded comparison of bowel colonoscopy cleansing and tolerability of a prespecified low-residue diet compared with a clear liquid diet and Polyethylene Glycol bowel preparation. Outcome measures included efficacy of bowel preparation, patient preparation tolerability and side-effects.
Read the detailed description
An adequate examination is dependent on the bowel colonoscopy cleansing of stool. There are many different colon preparations, however endoscopists traditionally recommend the patient remain on a clear liquid diet for at least 24 h prior to their colonoscopy to reduce continued residue inflow into the colon from the small bowel, in addition the large volume preparation with PEG. The most common problems leading to less than adequate colon cleansing include lack of compliance with the clear liquid diet and difficulty taking the large volume preparation.
- Conditions
- Colonoscopy
- Being tested
- Clear Liquid Diet, Low-residue Diet
- Keywords
- Dietary fiber
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clear Liquid DietDietary supplement
Clear liquid diet was compared with low-residue diet, in combination with Poliethylene Glycol in each group
Low-residue DietDietary supplement
Clear liquid diet was compared with low-residue diet, in combination with Poliethylene Glycol in each group
| Study group | Role | What they receive |
|---|---|---|
| Clear Liquid Diet | Active comparator | 110 subjects received clear liquid diet 24 hours before colonoscopy Receives: Dietary Supplement: Clear Liquid Diet |
| Low-residue Diet | Active comparator | 105 subjects received a prespecified low-residue diet 24 hours before colonoscopy Receives: Dietary Supplement: Low-residue Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of bowel colonoscopy preparation
The quality of cleansing was recorded using the Boston Bowel Preparation Scale (BBPS), a four-point scoring system applied to each of the three broad regions of the colon (right=cecum and ascending, transverse= including the hepatic and splenic flexures and left=descending, sigmoid and rectum) during withdrawal. The point was assigned as 0= unprepared to 3=entire mucosa of colon segment seen well with no residual staining. Successful colon cleansing was considered when BBPS were >2 per segment.
Measured: 1 day
Secondary outcomes (2)
Tolerability
Patient tolerability was assessed using Viera scale (Likert), which measures the intensity of the symptoms related to the bowel preparation including nausea, vomiting, abdominal pain, abdominal distension and anal discomfort. The six-point scale ranging from 0-1=no complaints or some; 2-3=moderate and 4-5=severe symptoms.
Measured: 1 day
Satisfaction
Data on satisfaction were collected with a 1 to 10 visual analogue scale. Volume PEG consumed were evaluated as quartile (0%, 25%, 50%, 75% and 100%) prior colonoscopy.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study startJun 2014
- Primary completionFeb 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 215 subjects were randomly assigned for this study, 105 in the clear liquid diet and 100 in the low residue-diet, 5 subjects were excluded in each group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FELIX IGNACIO TELLEZ AVILA, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358537
- Sponsor's protocol ID
- 001157
- Acronym
- PEG
- Status last verified
- Mar 2018
- First submitted
- 25 Nov 2017
- Last updated
- 20 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Delegge M, Kaplan R. Efficacy of bowel preparation with the use of a prepackaged, low fibre diet with a low sodium, magnesium citrate cathartic vs. a clear liquid diet with a standard sodium phosphate cathartic. Aliment Pharmacol Ther. 2005 Jun 15;21(12):1491-5. doi: 10.1111/j.1365-2036.2005.02494.x.
PubMed 15948817Hassan C, Bretthauer M, Kaminski MF, Polkowski M, Rembacken B, Saunders B, Benamouzig R, Holme O, Green S, Kuiper T, Marmo R, Omar M, Petruzziello L, Spada C, Zullo A, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2013;45(2):142-50. doi: 10.1055/s-0032-1326186. Epub 2013 Jan 18.
PubMed 23335011Park DI, Park SH, Lee SK, Baek YH, Han DS, Eun CS, Kim WH, Byeon JS, Yang SK. Efficacy of prepackaged, low residual test meals with 4L polyethylene glycol versus a clear liquid diet with 4L polyethylene glycol bowel preparation: a randomized trial. J Gastroenterol Hepatol. 2009 Jun;24(6):988-91. doi: 10.1111/j.1440-1746.2009.05860.x.
PubMed 19638081Rapier R, Houston C. A prospective study to assess the efficacy and patient tolerance of three bowel preparations for colonoscopy. Gastroenterol Nurs. 2006 Jul-Aug;29(4):305-8. doi: 10.1097/00001610-200607000-00007.
PubMed 16974167
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Low-residue Diet is a Good Option for Patients With PEG Based Colon Preparation: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03358537
- Acronym / sponsor ID
- PEG / 001157
- Conditions
- Colonoscopy
- Keywords
- Dietary fiber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 30 Nov 2017 (actual)
- 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.
This was a randomized, endoscopists' blinded comparison of bowel colonoscopy cleansing and tolerability of a prespecified low-residue diet compared with a clear liquid diet and Polyethylene Glycol bowel preparation. Outcome measures included efficacy of bowel preparation, patient preparation tolerability and side-effects.
Detailed description
An adequate examination is dependent on the bowel colonoscopy cleansing of stool. There are many different colon preparations, however endoscopists traditionally recommend the patient remain on a clear liquid diet for at least 24 h prior to their colonoscopy to reduce continued residue inflow into the colon from the small bowel, in addition the large volume preparation with PEG. The most common problems leading to less than adequate colon cleansing include lack of compliance with the clear liquid diet and difficulty taking the large volume preparation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- A total of 215 subjects were randomly assigned for this study, 105 in the clear liquid diet and 100 in the low residue-diet, 5 subjects were excluded in each group
| Arm | Type | Receives |
|---|---|---|
| Clear Liquid Diet | Active comparator | Dietary Supplement: Clear Liquid Diet110 subjects received clear liquid diet 24 hours before colonoscopy |
| Low-residue Diet | Active comparator | Dietary Supplement: Low-residue Diet105 subjects received a prespecified low-residue diet 24 hours before colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Out-patient scheduled for colonoscopy
Key exclusion criteria (5 listed)
- Subjects under 18 years of age
- Pregnancy
- Subjects with decompensated metabolic, renal, cardiac and psychiatric disease
- Allergy to PEG
- Refuse participation
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 |
|---|---|---|
| Clear Liquid DietClear liquid diet was compared with low-residue diet, in combination with Poliethylene Glycol in each group | Dietary supplement | Clear Liquid Diet |
| Low-residue DietClear liquid diet was compared with low-residue diet, in combination with Poliethylene Glycol in each group | Dietary supplement | Low-residue Diet |
Primary outcome
Quality of bowel colonoscopy preparation
Time frame: 1 day
The quality of cleansing was recorded using the Boston Bowel Preparation Scale (BBPS), a four-point scoring system applied to each of the three broad regions of the colon (right=cecum and ascending, transverse= including the hepatic and splenic flexures and left=descending, sigmoid and rectum) during withdrawal. The point was assigned as 0= unprepared to 3=entire mucosa of colon segment seen well with no residual staining. Successful colon cleansing was considered when BBPS were >2 per segment.
2 secondary outcomes
Tolerability
Time frame: 1 day
Satisfaction
Time frame: 1 day
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 20 Mar 2018.
- Results publication: PubMed 15948817Delegge M, Kaplan R. Efficacy of bowel preparation with the use of a prepackaged, low fibre diet with a low sodium, magnesium citrate cathartic vs. a clear liquid diet with a standard sodium phosphate cathartic. Aliment Pharmacol Ther. 2005 Jun 15;21(12):1491-5. doi: 10.1111/j.1365-2036.2005.02494.x.
- Results publication: PubMed 23335011Hassan C, Bretthauer M, Kaminski MF, Polkowski M, Rembacken B, Saunders B, Benamouzig R, Holme O, Green S, Kuiper T, Marmo R, Omar M, Petruzziello L, Spada C, Zullo A, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2013;45(2):142-50. doi: 10.1055/s-0032-1326186. Epub 2013 Jan 18.
- Results publication: PubMed 19638081Park DI, Park SH, Lee SK, Baek YH, Han DS, Eun CS, Kim WH, Byeon JS, Yang SK. Efficacy of prepackaged, low residual test meals with 4L polyethylene glycol versus a clear liquid diet with 4L polyethylene glycol bowel preparation: a randomized trial. J Gastroenterol Hepatol. 2009 Jun;24(6):988-91. doi: 10.1111/j.1440-1746.2009.05860.x.
- Results publication: PubMed 16974167Rapier R, Houston C. A prospective study to assess the efficacy and patient tolerance of three bowel preparations for colonoscopy. Gastroenterol Nurs. 2006 Jul-Aug;29(4):305-8. doi: 10.1097/00001610-200607000-00007.
- Individual participant dataSharing planned: No
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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 Clear Liquid Diet and Low-residue Diet in people with Colonoscopy, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.
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 5 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 20 Mar 2018. 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?
Quality of bowel colonoscopy preparation (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03358537, which also lists 4 linked publications.
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 20 Mar 2018.