Colon DiseaseNCT02955901

3-day vs. 1-day Low Residue Diet Influence in Colonoscopy Preparation and Patient Tolerability

A study testing 3 day low residue diet prior to the colonoscopy and 1 day low residue diet prior to the colonoscopy in people with Colon Disease and Colonic Neoplasms, run by Portuguese Oncology Institute, Coimbra at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Colonoscopy is one of the most common methods for the diagnosis and treatment of lower gastrointestinal tract diseases and provides a unique opportunity to identify early neoplastic lesions. Adequate bowel preparation is important for optimal colonoscopy. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Colon Disease, Colonic Neoplasms
What is being tested?: 3 day low residue diet prior to the colonoscopy and 1 day low residue diet prior to the colonoscopy
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 412 participants
Where: 1 sitePortugal
Study dates: 1 Jan 2017to May 2019
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

Consecutive series of patients scheduled for total colonoscopy
Signed informed consent

Who cannot join

inpatients
sedation
urgent procedures
colonoscopies not intended to reach the caecum
patient with previous partial colectomy.

Trial locations and contacts

1 site in 1 country.

Portugal1 site

Portuguese Oncology Institute - Coimbra
Coimbra, 3001 - 651

Other trials in Portugal

About this study

Official title: A 3-day Versus 1-day Low Residue Diet to Improve Colonoscopy Preparation Result and Patient Tolerability: A Prospective, Randomized, Single-blinded, Controlled Trial

Colonoscopy is one of the most common methods for the diagnosis and treatment of lower gastrointestinal tract diseases and provides a unique opportunity to identify early neoplastic lesions.

Adequate bowel preparation is important for optimal colonoscopy. New bowel-cleansing regimens, study of patient-related risk factors to fail a proper preparation and diet adaptations have been studied recently.

A low residue diet is the standard in the day before the colonoscopy. Some endoscopists prescribe this dietary plan for a 3-day period prior to the exam, although no study compared the recommended 1-day versus 3-day diet regime, or the influence in bowel preparation results.

The aim of this project is to determine if the use of a 3-day low residue diet improves bowel preparations results and the influence in patient tolerability and adherence.

Read the detailed description

Study type: prospective, randomized, single-blinded trial:
Prospective inclusion of ambulatory patients; ii. Randomization by computer generated tables; iii. Allocation concealment by sealed, opaque envelopes; iv. Patient not blinded to diet;
Endoscopist blinded to the diet followed by each patient.
Patient selection: Consecutive series of patients scheduled for total colonoscopy; Exclusion criteria: inpatients, sedation, urgent procedures, colonoscopies not intended to reach the caecum, patient with previous partial colectomy.
Sample Size:
412 individuals; 2 groups of 206 patients ii. Primary goal: to achieve a reduction from 15 to 5% of inappropriate preparation result; The Boston Bowel Preparation Scale (BBPS) will be used as grading system. Inappropriate is defined as total BBPS < 6 or < 2 in any segment. The chosen scale is the most systematically validated and appropriate for the clinical setting. iii.Both groups, from a community-based outpatient ambulatory center, used the same split dose regimen with Polyethylene glycol (PEG).Patients were instructed to drink 3 L of PEG preparation on the afternoon of the day prior to the exam and 1 L four hours before the scheduled exam time. All the exams scheduled for morning period. Assuming a normal distribution, a power of 90% and a type I error of 0.05, the calculated sample size for each group was 188; allowing a 10% dropout rate, the sample size is 206 per group (412 patients overall); Groups: Group A: 3-day low residue diet + split dose preparation; Group B: 1-day low residue diet + split dose preparation
Endoscopist:

Exams to be conduct by 5 board-certified gastroenterologists and 2 supervised fellows in training; All physicians were trained in the use of BBPS by online training available at http://cori.org/bbps/, and have been using the BBPS for at least 3 months.

Data collection methods: form sheet filled by the endoscopist and patient opinion regarding the assigned bowel preparation protocol.
Analyzed variables:
Primary outcome: BBPS score ii. Secondary outcome: Patient assessment of tolerance and acceptance of the preparation and diet iii. Tertiary outcome: polyp detection rate (PDR), polyp location, size and configuration; adenoma detection rate (ADR), cecum intubation rate iv. Other variables and patients characteristics (age, gender, chronic medication, risk factors for inappropriate preparation), withdrawal time.
Statistical analysis: T-test for groups comparing quantitative variables with normal distribution (primary outcome); Qui square test for groups comparing proportions (secondary and tertiary outcomes)

Conditions: Colon Disease, Colonic Neoplasms
Being tested: 3 day low residue diet prior to the colonoscopy, 1 day low residue diet prior to the colonoscopy
Keywords: Randomized controlled trial, Colonoscopy, Colon Disease, Low residue diet, Colon preparation
Medical subject headings: Colonic Diseases, Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

3 day low residue diet prior to the colonoscopyOther
3 day low residue diet prior to the colonoscopy
1 day low residue diet prior to the colonoscopyOther
3 day low residue diet prior to the colonoscopy

Study groups in NCT02955901
Study group	Role	What they receive
3-day low residue diet	Active comparator	Group A - 3 day low residue diet prior to the colonoscopy Receives: Other: 3 day low residue diet prior to the colonoscopy
1-day low residue diet	Placebo comparator	Group B - 1 day low residue diet prior to the colonoscopy Receives: Other: 1 day low residue diet prior to the colonoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

Score of mucosal visualization
Using Boston Bowel Preparation Scale during the exam
Measured: 1 day (during colonoscopy)

Secondary outcomes (5)

Patient assessment of diet protocol
Patient assessment, by written questionnaire, of tolerance and acceptance of diet protocol.
Measured: 1 day (the day of the exam)
Polyp detection rate, location and configuration
One of the quality indicators for colonoscopy is polyp detection rate, which is defined as the percentage of colonoscopies with a detection of at least one polyp. At the same time the endoscopist will assign the colonic location of the polyp (ascendent, transverse, descendent).
(PDR to be presented as %; Location to be discriminated in the endoscopist report).
Measured: 1 day (during colonoscopy)
Adenoma Detection Rate
Adenoma detection rate (ADR) is the one of the strongest quality indicators for colonoscopy. This rate represents the percentage of colonoscopies with at least one adenoma identified. (to be presented as %)
Measured: Within 30 days from colonoscopy date
Cecum intubation rate
Defined as colonoscopy quality indicator the photo documentation of cecum, in at least 95% of the colonoscopies. Photo documentation of the cecum is a mark for effective total colonoscopy. (to presented as %)
Measured: 1 day (during colonoscopy)
Withdrawal time
In a negative colonoscopy (no polyp identification) is defined that the withdrawal time should be at least 6 minutes for proper and safe colonic mucosa evaluation. (to be presented in minutes)
Measured: 1 day (during colonoscopy)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 2017May 2019

First posted4 Nov 2016 (estimated)
Study start1 Jan 2017
Primary completionDec 2018
Study completionMay 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Colon DiseaseStudies 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: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Care provider
Enrolment: 412 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02955901
Sponsor's protocol ID: PortugueseOIC 002
Status last verified: Jul 2019
First submitted: 25 Oct 2016
Last updated: 16 Jul 2019
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Rex DK, Schoenfeld PS, Cohen J, Pike IM, Adler DG, Fennerty MB, Lieb JG 2nd, Park WG, Rizk MK, Sawhney MS, Shaheen NJ, Wani S, Weinberg DS. Quality indicators for colonoscopy. Gastrointest Endosc. 2015 Jan;81(1):31-53. doi: 10.1016/j.gie.2014.07.058. Epub 2014 Dec 2. No abstract available.
PubMed 25480100
Hassan 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 23335011
ASGE Standards of Practice Committee; Saltzman JR, Cash BD, Pasha SF, Early DS, Muthusamy VR, Khashab MA, Chathadi KV, Fanelli RD, Chandrasekhara V, Lightdale JR, Fonkalsrud L, Shergill AK, Hwang JH, Decker GA, Jue TL, Sharaf R, Fisher DA, Evans JA, Foley K, Shaukat A, Eloubeidi MA, Faulx AL, Wang A, Acosta RD. Bowel preparation before colonoscopy. Gastrointest Endosc. 2015 Apr;81(4):781-94. doi: 10.1016/j.gie.2014.09.048. Epub 2015 Jan 14. No abstract available.
PubMed 25595062
Bucci C, Rotondano G, Hassan C, Rea M, Bianco MA, Cipolletta L, Ciacci C, Marmo R. Optimal bowel cleansing for colonoscopy: split the dose! A series of meta-analyses of controlled studies. Gastrointest Endosc. 2014 Oct;80(4):566-576.e2. doi: 10.1016/j.gie.2014.05.320. Epub 2014 Jul 19.
PubMed 25053529
Cohen LB. Advances in bowel preparation for colonoscopy. Gastrointest Endosc Clin N Am. 2015 Apr;25(2):183-97. doi: 10.1016/j.giec.2014.11.003. Epub 2015 Jan 9.
PubMed 25839681
Hautefeuille G, Lapuelle J, Chaussade S, Ponchon T, Molard BR, Coulom P, Laugier R, Henri F, Cadiot G. Factors related to bowel cleansing failure before colonoscopy: Results of the PACOME study. United European Gastroenterol J. 2014 Feb;2(1):22-9. doi: 10.1177/2050640613518200.
PubMed 24918005
Song GM, Tian X, Ma L, Yi LJ, Shuai T, Zeng Z, Zeng XT. Regime for Bowel Preparation in Patients Scheduled to Colonoscopy: Low-Residue Diet or Clear Liquid Diet? Evidence From Systematic Review With Power Analysis. Medicine (Baltimore). 2016 Jan;95(1):e2432. doi: 10.1097/MD.0000000000002432.
PubMed 26735547
Nguyen DL, Jamal MM, Nguyen ET, Puli SR, Bechtold ML. Low-residue versus clear liquid diet before colonoscopy: a meta-analysis of randomized, controlled trials. Gastrointest Endosc. 2016 Mar;83(3):499-507.e1. doi: 10.1016/j.gie.2015.09.045. Epub 2015 Oct 13.
PubMed 26460222
Lijoi D, Ferrero S, Mistrangelo E, Casa ID, Crosa M, Remorgida V, Alessandri F. Bowel preparation before laparoscopic gynaecological surgery in benign conditions using a 1-week low fibre diet: a surgeon blind, randomized and controlled trial. Arch Gynecol Obstet. 2009 Nov;280(5):713-8. doi: 10.1007/s00404-009-0986-3. Epub 2009 Feb 20.
PubMed 19229545
Vanhauwaert E, Matthys C, Verdonck L, De Preter V. Low-residue and low-fiber diets in gastrointestinal disease management. Adv Nutr. 2015 Nov 13;6(6):820-7. doi: 10.3945/an.115.009688. Print 2015 Nov.
PubMed 26567203
Calderwood AH, Jacobson BC. Comprehensive validation of the Boston Bowel Preparation Scale. Gastrointest Endosc. 2010 Oct;72(4):686-92. doi: 10.1016/j.gie.2010.06.068.
PubMed 20883845
Parmar R, Martel M, Rostom A, Barkun AN. Validated Scales for Colon Cleansing: A Systematic Review. Am J Gastroenterol. 2016 Feb;111(2):197-204; quiz 205. doi: 10.1038/ajg.2015.417. Epub 2016 Jan 19.
PubMed 26782820

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Colon Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 3-day Versus 1-day Low Residue Diet to Improve Colonoscopy Preparation Result and Patient Tolerability: A Prospective, Randomized, Single-blinded, Controlled Trial
ClinicalTrials.gov ID: NCT02955901
Acronym / sponsor ID: PortugueseOIC 002
Conditions: Colon Disease, Colonic Neoplasms
Keywords: Randomized controlled trial, Colonoscopy, Colon Disease, Low residue diet, Colon preparation
Study type: Interventional
Recruitment status: Completed
Enrolment: 412 participants (actual)
Lead sponsor: Portuguese Oncology Institute, CoimbraUniversity, hospital or other
Study start: 1 Jan 2017 (actual)
Primary completion: Dec 2018 (actual)
Study completion: May 2019 (actual)
First posted: 4 Nov 2016 (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.

Colonoscopy is one of the most common methods for the diagnosis and treatment of lower gastrointestinal tract diseases and provides a unique opportunity to identify early neoplastic lesions.

The aim of this project is to determine if the use of a 3-day low residue diet improves bowel preparations results and the influence in patient tolerability and adherence.

Detailed description

Study type: prospective, randomized, single-blinded trial:
Prospective inclusion of ambulatory patients; ii. Randomization by computer generated tables; iii. Allocation concealment by sealed, opaque envelopes; iv. Patient not blinded to diet;
Endoscopist blinded to the diet followed by each patient.
Patient selection: Consecutive series of patients scheduled for total colonoscopy; Exclusion criteria: inpatients, sedation, urgent procedures, colonoscopies not intended to reach the caecum, patient with previous partial colectomy.
Sample Size:
412 individuals; 2 groups of 206 patients ii. Primary goal: to achieve a reduction from 15 to 5% of inappropriate preparation result; The Boston Bowel Preparation Scale (BBPS) will be used as grading system. Inappropriate is defined as total BBPS < 6 or < 2 in any segment. The chosen scale is the most systematically validated and appropriate for the clinical setting. iii.Both groups, from a community-based outpatient ambulatory center, used the same split dose regimen with Polyethylene glycol (PEG).Patients were instructed to drink 3 L of PEG preparation on the afternoon of the day prior to the exam and 1 L four hours before the scheduled exam time. All the exams scheduled for morning period. Assuming a normal distribution, a power of 90% and a type I error of 0.05, the calculated sample size for each group was 188; allowing a 10% dropout rate, the sample size is 206 per group (412 patients overall); Groups: Group A: 3-day low residue diet + split dose preparation; Group B: 1-day low residue diet + split dose preparation
Endoscopist:

Data collection methods: form sheet filled by the endoscopist and patient opinion regarding the assigned bowel preparation protocol.
Analyzed variables:
Primary outcome: BBPS score ii. Secondary outcome: Patient assessment of tolerance and acceptance of the preparation and diet iii. Tertiary outcome: polyp detection rate (PDR), polyp location, size and configuration; adenoma detection rate (ADR), cecum intubation rate iv. Other variables and patients characteristics (age, gender, chronic medication, risk factors for inappropriate preparation), withdrawal time.
Statistical analysis: T-test for groups comparing quantitative variables with normal distribution (primary outcome); Qui square test for groups comparing proportions (secondary and tertiary outcomes)

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (care provider)
Number of arms: 2

Arm	Type	Receives
3-day low residue diet	Active comparator	Other: 3 day low residue diet prior to the colonoscopyGroup A - 3 day low residue diet prior to the colonoscopy
1-day low residue diet	Placebo comparator	Other: 1 day low residue diet prior to the colonoscopyGroup B - 1 day low residue diet prior to the colonoscopy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Consecutive series of patients scheduled for total colonoscopy
Signed informed consent

Key exclusion criteria (5 listed)

inpatients
sedation
urgent procedures
colonoscopies not intended to reach the caecum
patient with previous partial colectomy.

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
3 day low residue diet prior to the colonoscopy3 day low residue diet prior to the colonoscopy	Other	3-day low residue diet
1 day low residue diet prior to the colonoscopy3 day low residue diet prior to the colonoscopy	Other	1-day low residue diet

Primary outcome

Score of mucosal visualization
Time frame: 1 day (during colonoscopy)
Using Boston Bowel Preparation Scale during the exam

5 secondary outcomes

Patient assessment of diet protocol
Time frame: 1 day (the day of the exam)
Polyp detection rate, location and configuration
Time frame: 1 day (during colonoscopy)
Adenoma Detection Rate
Time frame: Within 30 days from colonoscopy date
Cecum intubation rate
Time frame: 1 day (during colonoscopy)
Withdrawal time
Time frame: 1 day (during colonoscopy)

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 16 Jul 2019.
Background: PubMed 25480100Rex DK, Schoenfeld PS, Cohen J, Pike IM, Adler DG, Fennerty MB, Lieb JG 2nd, Park WG, Rizk MK, Sawhney MS, Shaheen NJ, Wani S, Weinberg DS. Quality indicators for colonoscopy. Gastrointest Endosc. 2015 Jan;81(1):31-53. doi: 10.1016/j.gie.2014.07.058. Epub 2014 Dec 2. No abstract available.
Background: 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.
Background: PubMed 25595062ASGE Standards of Practice Committee; Saltzman JR, Cash BD, Pasha SF, Early DS, Muthusamy VR, Khashab MA, Chathadi KV, Fanelli RD, Chandrasekhara V, Lightdale JR, Fonkalsrud L, Shergill AK, Hwang JH, Decker GA, Jue TL, Sharaf R, Fisher DA, Evans JA, Foley K, Shaukat A, Eloubeidi MA, Faulx AL, Wang A, Acosta RD. Bowel preparation before colonoscopy. Gastrointest Endosc. 2015 Apr;81(4):781-94. doi: 10.1016/j.gie.2014.09.048. Epub 2015 Jan 14. No abstract available.
Background: PubMed 25053529Bucci C, Rotondano G, Hassan C, Rea M, Bianco MA, Cipolletta L, Ciacci C, Marmo R. Optimal bowel cleansing for colonoscopy: split the dose! A series of meta-analyses of controlled studies. Gastrointest Endosc. 2014 Oct;80(4):566-576.e2. doi: 10.1016/j.gie.2014.05.320. Epub 2014 Jul 19.
Background: PubMed 25839681Cohen LB. Advances in bowel preparation for colonoscopy. Gastrointest Endosc Clin N Am. 2015 Apr;25(2):183-97. doi: 10.1016/j.giec.2014.11.003. Epub 2015 Jan 9.
Background: PubMed 24918005Hautefeuille G, Lapuelle J, Chaussade S, Ponchon T, Molard BR, Coulom P, Laugier R, Henri F, Cadiot G. Factors related to bowel cleansing failure before colonoscopy: Results of the PACOME study. United European Gastroenterol J. 2014 Feb;2(1):22-9. doi: 10.1177/2050640613518200.
Background: PubMed 26735547Song GM, Tian X, Ma L, Yi LJ, Shuai T, Zeng Z, Zeng XT. Regime for Bowel Preparation in Patients Scheduled to Colonoscopy: Low-Residue Diet or Clear Liquid Diet? Evidence From Systematic Review With Power Analysis. Medicine (Baltimore). 2016 Jan;95(1):e2432. doi: 10.1097/MD.0000000000002432.
Background: PubMed 26460222Nguyen DL, Jamal MM, Nguyen ET, Puli SR, Bechtold ML. Low-residue versus clear liquid diet before colonoscopy: a meta-analysis of randomized, controlled trials. Gastrointest Endosc. 2016 Mar;83(3):499-507.e1. doi: 10.1016/j.gie.2015.09.045. Epub 2015 Oct 13.
Background: PubMed 19229545Lijoi D, Ferrero S, Mistrangelo E, Casa ID, Crosa M, Remorgida V, Alessandri F. Bowel preparation before laparoscopic gynaecological surgery in benign conditions using a 1-week low fibre diet: a surgeon blind, randomized and controlled trial. Arch Gynecol Obstet. 2009 Nov;280(5):713-8. doi: 10.1007/s00404-009-0986-3. Epub 2009 Feb 20.
Background: PubMed 26567203Vanhauwaert E, Matthys C, Verdonck L, De Preter V. Low-residue and low-fiber diets in gastrointestinal disease management. Adv Nutr. 2015 Nov 13;6(6):820-7. doi: 10.3945/an.115.009688. Print 2015 Nov.
Background: PubMed 20883845Calderwood AH, Jacobson BC. Comprehensive validation of the Boston Bowel Preparation Scale. Gastrointest Endosc. 2010 Oct;72(4):686-92. doi: 10.1016/j.gie.2010.06.068.
Background: PubMed 26782820Parmar R, Martel M, Rostom A, Barkun AN. Validated Scales for Colon Cleansing: A Systematic Review. Am J Gastroenterol. 2016 Feb;111(2):197-204; quiz 205. doi: 10.1038/ajg.2015.417. Epub 2016 Jan 19.
BBPS trainingLink provided by the sponsor.
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.

Filipe Taveira, MD principal investigator

Portuguese Oncology Institute, Coimbra

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 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 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Score of mucosal visualization (time frame: 1 day (during colonoscopy)). 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 NCT02955901, which also lists 12 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 16 Jul 2019.