AzTrials
AzTrials

Inflammatory Bowel DiseasesNCT05485103

A Prospective Study of the Effect of Modified Colonoscopy Bowel Preparation Program on Intestinal Cleaning, Examination and Disease in Patients With Inflammatory Bowel Disease

A study testing Polyethylene Glycols in people with Inflammatory Bowel Diseases, run by Peking Union Medical College Hospital at 9 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The purpose of this study is to investigate the effect of modified colonoscopy bowel preparation method compared with traditional method on bowel cleansing effect, colonoscopy examination effect and clinical condition of inflammatory bowel disease patients. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Inflammatory Bowel Diseases
What is being tested?
Polyethylene Glycols
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
9 sitesChina
Study dates
1 Sep 2022to 31 Dec 2024
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis: inflammatory bowel disease (IBD) patients, including ulcerative colitis (UC) and Crohn's disease (CD), have colonic involvement.
  • Patients and/or family members can understand the study protocol and are willing to participate in the study and provide informed consent in writing.

Who cannot join

  • The diagnosis is not definite.
  • Toxic megacolon, gastrointestinal perforation or other acute abdominal diseases; Patients with gastrointestinal bleeding with unstable vital signs.
  • Patients after colon surgery.
  • Serious underlying diseases, organ failure, or inability to cooperate with colonoscopy for other reasons.
  • Patients can not cooperate with the use of polyethylene glycol or glycerin enema.
  • Patients or family members cannot understand the conditions and objectives of this study.

Trial locations and contacts

9 sites in 1 country.

Hui Xu, MD contact

+86-010-69151591

xuhui10799@pumch.cn

Hong Yang, MD contact

yangh@pumch.cn

9 sites in 1 country

China9 sites, 9 recruiting

  • The second Affiliated Hospital of Baotou Medical Colledge

    Baotou, Neimenggu

    Lin Liu

    Recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Hui Xu, MD, +86-010-69151591, xuhui10799@pumch.cn

    Hui Xu, MD

    Recruiting

  • Beijing Chaoyang Hospital, Capital Medical University

    Beijing, Beijing Municipality

    Xinjuan Liu

    Recruiting

  • Beijing Sixth Hospital

    Beijing, Beijing Municipality

    Zuoyan Wu

    Recruiting

  • Beijing Rectum Hospital

    Beijing

    Junmei Zhang

    Recruiting

  • Heilongjiang Provincial Hospital

    Harbin, Heilongjiang

    Yue Yang

    Recruiting

  • The First People's Hospital of Yunnan Province

    Kunming, Yunnan

    Linting Xun

    Recruiting

  • The first Hospital of China Medical University

    Shenyang, Liaoning

    Xiuying Xu

    Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

    Yanjun Chen

    Recruiting

Other trials in China

About this study

The purpose of this study is to investigate the effect of modified colonoscopy bowel preparation method compared with traditional method on bowel cleansing effect, colonoscopy examination effect and clinical condition of inflammatory bowel disease patients. Risk factors affecting the quality of bowel preparation will also be studied.

Being tested
Polyethylene Glycols
Keywords
modified bowel preparation method, inflammatory bowel disease, risk factors, quality of bowel preparation
Medical subject headings
Inflammatory Bowel Diseases

What participants receive

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

  • Polyethylene GlycolsDrug

    Also called glycerin enema, asol

    Take asol as total enteral nutrition, and take polyethylene glycols and glycerin enema as bowel preparations

Study groups in NCT05485103
Study groupRoleWhat they receive
Modified bowel preparation method groupExperimentalOne day before the colonoscopy, only asol (or other intestinal nutrient solution) was taken. On the examination day (4 hours before), 1 bag of polyethylene glycol solution + (2 hours before) glycerin enema 110ml was taken
Receives: Drug: Polyethylene Glycols
Traditional bowel preparation method groupActive comparatorLow residue diet 2 days before the colonoscopy, take 2 bags of polyethylene glycol solution the night before the examination and 1 bag of which on the examination day (4 hours before)
Receives: Drug: Polyethylene Glycols

What is being measured

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

  1. The quality of bowel preparation evaluated by endoscopists during colonoscopy.

    The quality of bowel preparation will be evaluated with the Boston bowel preparation scale (BBPS), including the total Boston score (range 0-9, score 8-9 means excellent, 7 means good, less than 7 means bad) and score of per bowel segment (maximum 3).

    Measured: During colonoscopy examination

  2. Number of Participants with increased Disease activity after colonoscopy.

    Disease activity will be assessed using C-reactive protein (CRP) measurement, the modified Mayo score in ulcerative colitis and the Crohn's Disease Activity Index score in Crohn's Disease. If the result after colonoscopy was higher than before, the participant may be considered with increased disease activity.

    Measured: Within 7 days after colonoscopy

Secondary outcomes (3)

  1. Tolerance score of participants after bowel preparation.

    Tolerance score is defined range 0-10 (0 means totally intolerant, 10 means feel really good).

    Measured: After bowel preparation and before colonoscopy

  2. Number of Participants who has a record of outpatient or emergency treatment due to aggravation of disease after colonoscopy.

    Number of Participants who has a record of outpatient or emergency treatment due to aggravation of disease within 30 days after colonoscopy.

    Measured: Within 30 days after colonoscopy

  3. Number of Participants hospitalized because of aggravation of disease after colonoscopy.

    Number of Participants who is hospitalized because of aggravation of disease within 30 days after colonoscopy.

    Measured: Within 30 days after colonoscopy

Timeline

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

  1. First posted3 Aug 2022
  2. Study start1 Sep 2022
  3. Primary completion31 Jul 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

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
Masking
None (open label)
Enrolment
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05485103
Sponsor's protocol ID
ZS-3300
Status last verified
Jun 2023
First submitted
5 Jul 2022
Last updated
26 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sultan K, Trindade AJ. Concise Commentary: Is Splitting the Difference? Identifying Risk Factors Associated with Suboptimal Bowel Preparation for Colonoscopy Among IBD Patients. Dig Dis Sci. 2022 Oct;67(10):4602-4603. doi: 10.1007/s10620-022-07533-5. Epub 2022 May 17. No abstract available.

    PubMed 35579796

  • Kim KO, Kim EY, Lee YJ, Lee HS, Kim ES, Chung YJ, Jang BI, Kim SK, Yang CH. Efficacy, safety and tolerability of oral sulphate tablet for bowel preparation in patients with inflammatory bowel disease: A multicentre randomized controlled study. J Crohns Colitis. 2022 Nov 23;16(11):1706-1713. doi: 10.1093/ecco-jcc/jjac080.

    PubMed 35689818

  • Wijnands AM, Te Groen M, Peters Y, Kaptein AA, Oldenburg B, Hoentjen F, Lutgens MWMD. Patients Prioritize a Low-volume Bowel Preparation in Colitis-associated Colorectal Cancer Surveillance: A Discrete Choice Experiment. Inflamm Bowel Dis. 2022 Jul 1;28(7):1053-1060. doi: 10.1093/ibd/izab221.

    PubMed 34487155

  • Reddy P, Mencin A, Lebwohl B. Risk Factors for Suboptimal Bowel Preparation for Colonoscopy in Pediatric Patients. J Pediatr Gastroenterol Nutr. 2021 Jul 1;73(1):e1-e6. doi: 10.1097/MPG.0000000000003114.

    PubMed 33661246

  • Neri B, Scarozza P, Giannarelli D, Sena G, Mossa M, Lolli E, Calabrese E, Biancone L, Grasso E, Di Iorio L, Troncone E, Monteleone G, Paoluzi OA, Del Vecchio Blanco G. Efficacy and tolerability of very low-volume bowel preparation in patients with inflammatory bowel diseases. Eur J Gastroenterol Hepatol. 2021 Jul 1;33(7):977-982. doi: 10.1097/MEG.0000000000002167.

    PubMed 34034275

  • Maida M, Morreale GC, Sferrazza S, Sinagra E, Scalisi G, Vitello A, Vettori G, Rossi F, Catarella D, Di Bartolo CE, Schillaci D, Raimondo D, Camilleri S, Orlando A, Macaluso FS. Effectiveness and safety of 1L PEG-ASC preparation for colonoscopy in patients with inflammatory bowel diseases. Dig Liver Dis. 2021 Sep;53(9):1171-1177. doi: 10.1016/j.dld.2021.04.006. Epub 2021 May 12.

    PubMed 33994129

  • Negreanu L, Voiosu T, State M, Mateescu RB. Quality of colonoscopy preparation in patients with inflammatory bowel disease: retrospective analysis of 348 colonoscopies. J Int Med Res. 2020 Apr;48(4):300060520903654. doi: 10.1177/0300060520903654.

    PubMed 32237946

  • Megna B, Weiss J, Ley D, Saha S, Pfau P, Grimes I, Li Z, Caldera F. Clear liquid diet before bowel preparation predicts successful chromoendoscopy in patients with inflammatory bowel disease. Gastrointest Endosc. 2019 Feb;89(2):373-379.e2. doi: 10.1016/j.gie.2018.09.039. Epub 2018 Oct 16.

    PubMed 30339950

  • Briot C, Faure P, Parmentier AL, Nachury M, Trang C, Viennot S, Altwegg R, Bulois P, Thomassin L, Serrero M, Ah-Soune P, Gilletta C, Plastaras L, Simon M, Dray X, Caillo L, Del Tedesco E, Abitbol V, Zallot C, Degand T, Rossi V, Bonnaud G, Colin D, Morel B, Winkfield B, Danset JB, Filippi J, Amiot A, Attar A, Levy J, Peyrin-Biroulet L, Vuitton L; CLEAN Study Group. Efficacy, Tolerability, and Safety of Low-Volume Bowel Preparations for Patients with Inflammatory Bowel Diseases: The French Multicentre CLEAN Study. J Crohns Colitis. 2019 Sep 19;13(9):1121-1130. doi: 10.1093/ecco-jcc/jjz040.

    PubMed 30785181

  • Spiceland CM, Lodhia N. Endoscopy in inflammatory bowel disease: Role in diagnosis, management, and treatment. World J Gastroenterol. 2018 Sep 21;24(35):4014-4020. doi: 10.3748/wjg.v24.i35.4014.

    PubMed 30254405

  • Martel M, Menard C, Restellini S, Kherad O, Almadi M, Bouchard M, Barkun AN. Which Patient-Related Factors Determine Optimal Bowel Preparation? Curr Treat Options Gastroenterol. 2018 Dec;16(4):406-416. doi: 10.1007/s11938-018-0208-9.

    PubMed 30390208

  • Bezzio C, Andreozzi P, Casini V, Manes G, Saibeni S. Endoscopy for patients affected by inflammatory bowel disease: bowel preparation and sedation. Expert Rev Gastroenterol Hepatol. 2018 Feb;12(2):119-124. doi: 10.1080/17474124.2017.1390430. Epub 2017 Oct 17.

    PubMed 29019424

  • Shobar RM, Velineni S, Keshavarzian A, Swanson G, DeMeo MT, Melson JE, Losurdo J, Engen PA, Sun Y, Koenig L, Mutlu EA. The Effects of Bowel Preparation on Microbiota-Related Metrics Differ in Health and in Inflammatory Bowel Disease and for the Mucosal and Luminal Microbiota Compartments. Clin Transl Gastroenterol. 2016 Feb 11;7(2):e143. doi: 10.1038/ctg.2015.54.

    PubMed 26866392

  • Nett A, Velayos F, McQuaid K. Quality bowel preparation for surveillance colonoscopy in patients with inflammatory bowel disease is a must. Gastrointest Endosc Clin N Am. 2014 Jul;24(3):379-92. doi: 10.1016/j.giec.2014.03.004. Epub 2014 May 6.

    PubMed 24975529

  • Bessissow T, Van Keerberghen CA, Van Oudenhove L, Ferrante M, Vermeire S, Rutgeerts P, Van Assche G. Anxiety is associated with impaired tolerance of colonoscopy preparation in inflammatory bowel disease and controls. J Crohns Colitis. 2013 Dec;7(11):e580-7. doi: 10.1016/j.crohns.2013.04.011. Epub 2013 May 9.

    PubMed 23664621

Questions about this trial

What is this clinical trial studying?

A study testing Polyethylene Glycols in people with Inflammatory Bowel Diseases, run by Peking Union Medical College Hospital at 9 sites in China.

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 6 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: status not confirmed, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China. 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. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hui Xu, MD (+86-010-69151591, xuhui10799@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The quality of bowel preparation evaluated by endoscopists during colonoscopy. (time frame: During colonoscopy examination). The study lists 2 primary outcomes in all. 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 NCT05485103, which also lists 15 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 26 Dec 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in