Interest of Pan Capsule in Symptomatic Patients Suspected of Irritable Bowel Syndrome Requiring Colonoscopy

NCT03806959 | Completed

• 1 other identifier: 2017-A03229-44
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Irritable bowel syndrome (IBS) is a chronic disease characterized by the association of abdominal pain and transit disorders. IBS affects 5 to 10% of the population. There are several forms of IBS: IBS-D (with predominant diarrhea), IBS-C (with constipation predominant) and IBS-M (mixed with alternating diarrhea and constipation). In the absence of a diagnostic test to confirm the existence of this syndrome, the diagnosis of IBS is based on clinical criteria (Rome IV criteria). In patients suspected of IBS, especially in patients with diarrhea (IBS-D or IBS-M), a colonoscopy with biopsies is often proposed in addition to biological tests (Complete Blood Count, C-reactive protein, thyroid stimulating hormon and anti-transglutaminase antibodies) by the physician or gastroenterologist to exclude an organic digestive disease such as celiac disease, IBD (Crohn's disease or ulcerative colitis), microscopic colitis or even neoplasia. 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, ..).

Conditions

Irritable Bowel Syndrome With Diarrhea

Outcome Measures

Primary Outcomes (1)

• Number of patients with digestive pathology and / or significant gastrointestinal lesion.

  Number of patients with digestive pathology and / or significant gastrointestinal lesion (mucosal atrophy, mucosal erythema or ulceration, inflammatory bowel disease, neoplasia: colon adenocarcinoma, polyps\> 5 mm, microscopic colitis).

  1 month

Secondary Outcomes (2)

• Acceptability of the pan-capsule, preference of one of the carried out explorations (pan-capsule or iléo-colonoscopy).

  1 month

• Acceptability to complete the questionnaires (number of completed questionnaires).

  1 month

Study Arms (1)

Pan Capsule and colonoscopy

EXPERIMENTAL

Every patient will have both Pan Capsule and colonoscopy examinations Descriptive study only

Other: Pan Capsule and colonoscopy in patients with IBS

Interventions

Pan Capsule and colonoscopy in patients with IBS OTHER

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.

Pan Capsule and colonoscopy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female: Age ≥ 18 years and ≤ 50 years
• 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.

You may not qualify if:

• Functional or organic disorders of swallowing.
• Dysphagia or suspicion of digestive stenosis.
• Known Zenker Diverticule.
• 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.

Sponsors & Collaborators

• Hospital Avicenne: lead
• Adeprina: collaborator

Study Sites (1)

Centre de Recherche sur Volontaires (CRV), Hospital Avicenne

Bobigny, Île-de-France Region, 93000, France

Location

Related Publications (14)

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  PMID: 25199904 BACKGROUND

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  PMID: 25424580 BACKGROUND

• 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.

  PMID: 25653858 BACKGROUND

• 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.

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  PMID: 20152787 BACKGROUND

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  PMID: 20179696 BACKGROUND

• 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.

  PMID: 22460220 BACKGROUND

• 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.

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  PMID: 28839818 BACKGROUND

• 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.

  PMID: 27261204 BACKGROUND

MeSH Terms

Interventions

Colonoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Robert BENAMOUZIG, Professor

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Model Details: every patient will have both pan-capsule and colonoscopy. comparison intra-group between lesions found by the two examinations.

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 16, 2019
• Study Start: November 7, 2018
• Primary Completion: May 6, 2022
• Study Completion: June 30, 2022
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)