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Magnetically Controlled Capsule EndoscopyNCT06313242

Different Bowel Preparations in Magnetically Controlled Capsule Endoscopy

A study testing Polyethylene Glycol Electrolytes Powder (II), Low residue diet and Normal diet in people with Magnetically Controlled Capsule Endoscopy and Bowel Preparation, run by Qilu Hospital of Shandong University at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

The study aimed to compare the effects of bowel preparation methods of a normal diet for 1 day, a low residue diet for 1 day, and laxative bowel cleaning on the image quality of magnetically controlled capsule endoscopy, and to assess the rate of completion of the examination, small intestine transit time, lesion… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Polyethylene Glycol Electrolytes Powder (II), Low residue diet and Normal diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
375 participants
Where
1 siteChina
Study dates
14 Mar 2024to Jun 2025
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years, male or female
  • One of the following examination indications:
  • Unexplained gastrointestinal bleeding; (2) Unexplained iron deficiency anaemia; (3) Suspected Crohn's disease or monitoring and directing treatment for Crohn's disease; (4) Suspected small bowel tumour; (5) Monitoring the development of small bowel polyposis syndrome; (6) Suspected or difficult to control malabsorption syndromes (e.g., celiac disease, etc.); (7) Detection of NSAID-associated small bowel mucosal damage; (8) Those with a clinical need to exclude small bowel disease.

Who cannot join

  • People who are ineligible for surgery or refuse to undergo any abdominal surgery (once the capsule is retained it cannot be removed surgically);
  • Known or suspected gastrointestinal obstruction, stenosis, and fistula;
  • People with implanted cardiac pacemakers or other electronic devices;
  • People with swallowing disorders;
  • Women during pregnancy;
  • People who are unable or unwilling to provide informed consent.

Trial locations and contacts

1 site in 1 country.

Feixue Chen, Ph.D contact

18560086108

chenfeixue@email.sdu.edu.cn

China1 site, 1 recruiting

  • Qilu Hospital of Shandong University

    Jinan

    Feixue Chen, +8618560086108, chenfeixue@email.sdu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Evaluation of Different Bowel Preparations in Magnetically Controlled Capsule Endoscopy: a Randomized Controlled Study

The study aimed to compare the effects of bowel preparation methods of a normal diet for 1 day, a low residue diet for 1 day, and laxative bowel cleaning on the image quality of magnetically controlled capsule endoscopy, and to assess the rate of completion of the examination, small intestine transit time, lesion detection, patient tolerance, and safety of the three regimens.

Being tested
Polyethylene Glycol Electrolytes Powder (II), Low residue diet, Normal diet

What participants receive

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

  • Polyethylene Glycol Electrolytes Powder (II)Drug

    Also called laxatives for bowel preparation

    Polyethylene Glycol Electrolytes Powder (II) was used for bowel preparation.

  • Low residue dietOther

    Low residue diet 1 day before the test, fasting from 20:00 pm.

  • Normal dietOther

    Normal diet 1 day before the test, fasting from 20:00 pm.

Study groups in NCT06313242
Study groupRoleWhat they receive
Laxatives armActive comparatorNormal diet 1 day before the test, fasting and laxatives from 20:00 pm. The laxatives, Polyethylene Glycol Electrolytes Powder (II), should be prepared as a solution and taken as 2000 ml the night before the test and 1000 ml the following morning, within 2 hours and 1 hour, respectively.
Receives: Drug: Polyethylene Glycol Electrolytes Powder (II)
Low residue diet armExperimentalLow residue diet 1 day before the test, fasting from 20:00 pm.
Receives: Other: Low residue diet
Normal diet armExperimentalNormal diet 1 day before the test, fasting from 20:00 pm.
Receives: Other: Normal diet

What is being measured

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

  1. Image quality of small intestine

    The small bowel cleanliness score and the small bowel bubble volume score were used to evaluate image quality.

    Measured: 1 day (Upon completion of the examination)

Secondary outcomes (5)

  1. Rate of completion of inspections

    The examination is considered complete when the capsule reaches the cecum.

    Measured: 1 day (Upon completion of the examination)

  2. Small intestine transit time

    Time taken for the capsule to pass through the entire small intestine to reach the cecum.

    Measured: 1 day (Upon completion of the examination)

  3. Lesion detection rate

    Proportion of cases with lesions relevant to the indication for examination or capable of explaining the patient's complaints or symptoms to the total number of cases.

    Measured: 1 day (Upon completion of the examination)

  4. Patient tolerance

    Evaluated by completing a case report form based on the patient's personal feelings during the bowel preparation process.

    Measured: 1 day (Upon completion of the examination)

  5. Rate of adverse events

    Patients were observed for adverse events (nausea, vomiting, bloating, etc.) and for capsule retention after examination.

    Measured: 1 day (Upon completion of the examination)

Timeline

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

  1. First posted15 Mar 2024
  2. Study start14 Mar 2024
  3. Primary completionFeb 2025 (estimated)
  4. Study completionJun 2025 (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
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
375 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06313242
Sponsor's protocol ID
202403
Status last verified
Mar 2024
First submitted
10 Mar 2024
Last updated
19 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Han Y, Liao Z, Li Y, Zhao X, Ma S, Bao D, Qiu M, Deng J, Wang J, Qu P, Jiang C, Jia S, Yang S, Ru L, Feng J, Gao W, Huang Y, Tao L, Han Y, Yang K, Wang X, Zhang W, Wang B, Li Y, Yang Y, Li J, Sheng J, Ma Y, Cui M, Ma S, Wang X, Li Z, Stone GW. Magnetically Controlled Capsule Endoscopy for Assessment of Antiplatelet Therapy-Induced Gastrointestinal Injury. J Am Coll Cardiol. 2022 Jan 18;79(2):116-128. doi: 10.1016/j.jacc.2021.10.028. Epub 2021 Nov 6.

    PubMed 34752902

  • Wu TT, Zhang MY, Tan ND, Chen SF, Zhuang QJ, Luo Y, Xiao YL. Patients at risk for further examination with conventional gastroscopy after undergoing magnetically controlled capsule endoscopy. J Dig Dis. 2023 Oct;24(10):522-529. doi: 10.1111/1751-2980.13228. Epub 2023 Oct 3.

    PubMed 37681236

  • Jiang X, Qian YY, Liu X, Pan J, Zou WB, Zhou W, Luo YY, Chen YZ, Li ZS, Liao Z. Impact of magnetic steering on gastric transit time of a capsule endoscopy (with video). Gastrointest Endosc. 2018 Oct;88(4):746-754. doi: 10.1016/j.gie.2018.06.031. Epub 2018 Jul 11.

    PubMed 30005825

  • Kong QZ, Peng C, Li Z, Tian BL, Li YY, Chen FX, Zuo XL, Li YQ. Inadequate gastric preparation and its associated factors for magnetically controlled capsule endoscopy. Front Pharmacol. 2023 Aug 28;14:1184754. doi: 10.3389/fphar.2023.1184754. eCollection 2023.

    PubMed 37701026

  • Reumkens A, van der Zander Q, Winkens B, Bogie R, Bakker CM, Sanduleanu S, Masclee AAM. Electrolyte disturbances after bowel preparation for colonoscopy: Systematic review and meta-analysis. Dig Endosc. 2022 Jul;34(5):913-926. doi: 10.1111/den.14237. Epub 2022 Feb 23.

    PubMed 35037327

  • Gkolfakis P, Tziatzios G, Dimitriadis GD, Triantafyllou K. Meta-analysis of randomized controlled trials challenging the usefulness of purgative preparation before small-bowel video capsule endoscopy. Endoscopy. 2018 Jul;50(7):671-683. doi: 10.1055/s-0043-125207. Epub 2018 Feb 6.

    PubMed 29409067

  • Gomez-Reyes E, Tepox-Padron A, Cano-Manrique G, Vilchis-Valadez NJ, Mora-Bulnes S, Medrano-Duarte G, Chaires-Garza LG, Grajales-Figueroa G, Ruiz-Romero D, Tellez-Avila FI. A low-residue diet before colonoscopy tends to improve tolerability by patients with no differences in preparation quality: a randomized trial. Surg Endosc. 2020 Jul;34(7):3037-3042. doi: 10.1007/s00464-019-07100-6. Epub 2019 Sep 3.

    PubMed 31482360

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Polyethylene Glycol Electrolytes Powder (II), Low residue diet and Normal diet in people with Magnetically Controlled Capsule Endoscopy and Bowel Preparation, run by Qilu Hospital of Shandong University at 1 site 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 3 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 19 Mar 2024. 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 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 Feixue Chen, Ph.D (18560086108, chenfeixue@email.sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Image quality of small intestine (time frame: 1 day (Upon completion of the examination)). 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 NCT06313242, which also lists 8 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 19 Mar 2024.

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