Interest of Pan Capsule in Symptomatic Patients Suspected of Irritable Bowel Syndrome Requiring Colonoscopy
NCT ID: NCT03806959
Last Updated: 2024-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
33 participants
INTERVENTIONAL
2018-11-07
2022-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The colonoscopy is an invasive exploration and does not allow exploration of the entire small bowel.
The development of capsules allowed the exploration of the small bowel more recently of the colon. The new developed pan-capsule allows evaluation of both small bowel and colon.
The aim of this work is to evaluate in patients younger than 50 years, presenting suspicious digestive symptoms of IBS with diarrhea, the interest of a strategy based on the pan-capsule as an alternative to colonoscopy to eliminate a diagnosis of organic digestive disease (celiac disease, IBD, neoplasia, ..).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Dietary Supplementation on Intestinal Barrier Function in IBS-D
NCT06543498
Colonoscopy-related Pain Predicts the Treatment Response of Amitriptyline in Patients With Irritable Bowel Syndrome
NCT02638870
Intracolonic FODMAP Infusion in Healthy Volunteers
NCT06488534
A Study to Evaluate the Safety and Efficacy of RDX5791 for the Treatment of Constipation Predominant Irritable Bowel Syndrome (IBS-C)
NCT01340053
Association Between High Faecal Calprotectin, Increased Intestinal Permeability and Visceral Hypersensitivity in IBS-D Patients
NCT02550704
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pan Capsule and colonoscopy
Every patient will have both Pan Capsule and colonoscopy examinations Descriptive study only
Pan Capsule and colonoscopy in patients with IBS
Every patient will have both Pan Capsule and colonoscopy examinations Descriptive study only Usual biological tests (CBC, CRP, TSH, anti-transglutaminase antibodies) and measurement of fecal calprotectin.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pan Capsule and colonoscopy in patients with IBS
Every patient will have both Pan Capsule and colonoscopy examinations Descriptive study only Usual biological tests (CBC, CRP, TSH, anti-transglutaminase antibodies) and measurement of fecal calprotectin.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients with symptoms compatible with IBS-D or IBS-M according to the treating physician.
* Indication for colonoscopy according to the physician
* Absence of prior colonoscopy
* Patient affiliated to a social security Insurance
* Signature of signed informed consent.
Exclusion Criteria
* Dysphagia or suspicion of digestive stenosis.
* Known Zenker Diverticule.
* Major surgical history of the digestive tract (exclusion of appendectomy, cholecystectomy, surgery of hemorrhoids).
* Known illness that could explain digestive symptoms.
* Symptoms suggestive of occlusion.
* Alteration of the general state and / or dehydration.
* Chronic uncontrolled disease.
* Disorders of consciousness.
* Uncontrolled heart disease: myocardial infarction in the last 6 months, anginal disease status, NYHA grade III and above congestive heart failure, ventricular tachycardia, ventricular fibrillation, severe heart block.
* Patient with a pacemaker or other implantable electronic medical device.
* Polyethylene glycol allergy.
* Oral iron intake in the four days preceding the video capsule.
* Pregnant or lactating woman, woman of childbearing age who has not performed a pregnancy test, women and men of childbearing potential without effective contraception.
* Impossible follow up for psychological or geographical reasons.
* Patient under safeguard of justice.
* Patient under guardianship or curatorship.
* Simultaneous participation in another clinical study.
18 Years
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Adeprina
OTHER
Hospital Avicenne
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Robert Benamouzig
Professor, MD, PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert BENAMOUZIG, Professor
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre de Recherche sur Volontaires (CRV), Hospital Avicenne
Bobigny, Île-de-France Region, France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Le Pluart D, Sabate JM, Bouchoucha M, Hercberg S, Benamouzig R, Julia C. Functional gastrointestinal disorders in 35,447 adults and their association with body mass index. Aliment Pharmacol Ther. 2015 Apr;41(8):758-67. doi: 10.1111/apt.13143. Epub 2015 Mar 1.
Mearin F, Lacy BE, Chang L, Chey WD, Lembo AJ, Simren M, Spiller R. Bowel Disorders. Gastroenterology. 2016 Feb 18:S0016-5085(16)00222-5. doi: 10.1053/j.gastro.2016.02.031. Online ahead of print.
Gralnek IM, Hays RD, Kilbourne A, Naliboff B, Mayer EA. The impact of irritable bowel syndrome on health-related quality of life. Gastroenterology. 2000 Sep;119(3):654-60. doi: 10.1053/gast.2000.16484.
Canavan C, West J, Card T. Review article: the economic impact of the irritable bowel syndrome. Aliment Pharmacol Ther. 2014 Nov;40(9):1023-34. doi: 10.1111/apt.12938. Epub 2014 Sep 9.
Corsetti M, Van Oudenhove L, Tack J. The quest for biomarkers in IBS-where should it lead us? Neurogastroenterol Motil. 2014 Dec;26(12):1669-76. doi: 10.1111/nmo.12475.
Andresen V, Whorwell P, Fortea J, Auziere S. An exploration of the barriers to the confident diagnosis of irritable bowel syndrome: A survey among general practitioners, gastroenterologists and experts in five European countries. United European Gastroenterol J. 2015 Feb;3(1):39-52. doi: 10.1177/2050640614558344.
Quigley EM. Overlapping irritable bowel syndrome and inflammatory bowel disease: less to this than meets the eye? Therap Adv Gastroenterol. 2016 Mar;9(2):199-212. doi: 10.1177/1756283X15621230.
Spiller R, Camilleri M, Longstreth GF. Do the symptom-based, Rome criteria of irritable bowel syndrome lead to better diagnosis and treatment outcomes? Clin Gastroenterol Hepatol. 2010 Feb;8(2):125-9; discussion 129-36. doi: 10.1016/j.cgh.2009.12.018. No abstract available.
Lieberman DA, Holub J, Eisen G, Kraemer D, Morris CD. Utilization of colonoscopy in the United States: results from a national consortium. Gastrointest Endosc. 2005 Dec;62(6):875-83. doi: 10.1016/j.gie.2005.06.037.
Chey WD, Nojkov B, Rubenstein JH, Dobhan RR, Greenson JK, Cash BD. The yield of colonoscopy in patients with non-constipated irritable bowel syndrome: results from a prospective, controlled US trial. Am J Gastroenterol. 2010 Apr;105(4):859-65. doi: 10.1038/ajg.2010.55. Epub 2010 Feb 23.
Ishihara S, Yashima K, Kushiyama Y, Izumi A, Kawashima K, Fujishiro H, Kojo H, Komazawa Y, Hamamoto T, Yamamoto T, Sasaki Y, Shimizu T, Okamoto E, Yoshimura T, Furuta K, Noguchi N, Tanaka H, Murawaki Y, Kinoshita Y. Prevalence of organic colonic lesions in patients meeting Rome III criteria for diagnosis of IBS: a prospective multi-center study utilizing colonoscopy. J Gastroenterol. 2012 Oct;47(10):1084-90. doi: 10.1007/s00535-012-0573-4. Epub 2012 Mar 30.
Patel P, Bercik P, Morgan DG, Bolino C, Pintos-Sanchez MI, Moayyedi P, Ford AC. Prevalence of organic disease at colonoscopy in patients with symptoms compatible with irritable bowel syndrome: cross-sectional survey. Scand J Gastroenterol. 2015 Jul;50(7):816-23. doi: 10.3109/00365521.2015.1007079. Epub 2015 Jan 30.
Soubieres A, Wilson P, Poullis A, Wilkins J, Rance M. Burden of irritable bowel syndrome in an increasingly cost-aware National Health Service. Frontline Gastroenterol. 2015 Oct;6(4):246-251. doi: 10.1136/flgastro-2014-100542. Epub 2015 Feb 24.
Pimentel M, Purdy C, Magar R, Rezaie A. A Predictive Model to Estimate Cost Savings of a Novel Diagnostic Blood Panel for Diagnosis of Diarrhea-predominant Irritable Bowel Syndrome. Clin Ther. 2016 Jul;38(7):1638-1652.e9. doi: 10.1016/j.clinthera.2016.05.003. Epub 2016 May 31.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-A03229-44
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.