Back to results

Interest of Pan-capsule in Symptomatic Patients Suspected of Irritable Bowel Syndrome Requiring Colonoscopy (IPSILON)

Primary Purpose

Irritable Bowel Syndrome With Diarrhea

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Pan Capsule and colonoscopy in patients with IBS

About this trial

This is an interventional diagnostic trial for Irritable Bowel Syndrome With Diarrhea

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

Functional or organic disorders of swallowing.
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.

Sites / Locations

Centre de Recherche sur Volontaires (CRV), Hospital AvicenneRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Pan Capsule and colonoscopy

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Index of acceptability (visual analogy scale)

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

Number of completed questionnaire

Full Information

NCT ID

NCT03806959

First Posted

January 10, 2019

Last Updated

January 15, 2019

Sponsor

Hospital Avicenne

Collaborators

Adeprina

1. Study Identification

Unique Protocol Identification Number

NCT03806959

Brief Title

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

Acronym

IPSILON

Official Title

Interest of Pan Capsule (Small Bowel and Colon Video Capsule) in Symptomatic Patients Suspected of Irritable Bowel Syndrome Requiring Colonoscopy. Phase A. Feasibility

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 7, 2018 (Actual)

Primary Completion Date

November 7, 2020 (Anticipated)

Study Completion Date

June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Avicenne

Collaborators

Adeprina

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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, ..).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome With Diarrhea

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pan Capsule and colonoscopy

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Pan Capsule and colonoscopy in patients with IBS

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

1 month

Secondary Outcome Measure Information:

Title

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

Description

Index of acceptability (visual analogy scale)

Time Frame

1 month

Title

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

Description

Number of completed questionnaire

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: Functional or organic disorders of swallowing. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Robert BENAMOUZIG, Professor

Phone

+33148955334

robert.benamouzig@aphp.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Mourad BENALLAOUA, PhD

Phone

+33148955555

Ext

56534

mourad.benallaoua@aphp.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert BENAMOUZIG, Professor

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre de Recherche sur Volontaires (CRV), Hospital Avicenne

City

Bobigny

State/Province

Ile-de-France

ZIP/Postal Code

93000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robert Benamouzig, PU-PH

Phone

+33148955334

robert.benamouzig@aphp.frr

First Name & Middle Initial & Last Name & Degree

Mourad Benallaoua, PhD

Phone

+33148955555

Ext

56534

mourad.benallaoua@aphp.fr

First Name & Middle Initial & Last Name & Degree

Robert Benamouzig

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25728697

Citation

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.

Results Reference

background

PubMed Identifier

27144627

Citation

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.

Results Reference

background

PubMed Identifier

10982758

Citation

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.

Results Reference

background

PubMed Identifier

25199904

Citation

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.

Results Reference

background

PubMed Identifier

25424580

Citation

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.

Results Reference

background

PubMed Identifier

25653858

Citation

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.

Results Reference

background

PubMed Identifier

26929782

Citation

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.

Results Reference

background

PubMed Identifier

20152787

Citation

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.

Results Reference

background

PubMed Identifier

16301030

Citation

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.

Results Reference

background

PubMed Identifier

20179696

Citation

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.

Results Reference

background

PubMed Identifier

22460220

Citation

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.

Results Reference

background

PubMed Identifier

25636675

Citation

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.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs