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

July 30, 2024 updated by: Robert Benamouzig, Hospital Avicenne

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

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, ..).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile-de-France
      • Bobigny, Ile-de-France, France, 93000
        • Centre de Recherche sur Volontaires (CRV), Hospital Avicenne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pan Capsule and colonoscopy
Every patient will have both Pan Capsule and colonoscopy examinations Descriptive study only
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with digestive pathology and / or significant gastrointestinal lesion.
Time Frame: 1 month
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of the pan-capsule, preference of one of the carried out explorations (pan-capsule or iléo-colonoscopy).
Time Frame: 1 month
Index of acceptability (visual analogy scale)
1 month
Acceptability to complete the questionnaires (number of completed questionnaires).
Time Frame: 1 month
Number of completed questionnaire
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Avicenne

Collaborators

Adeprina

Investigators

  • Principal Investigator: Robert BENAMOUZIG, Professor, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2018

Primary Completion (Actual)

May 6, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

January 10, 2019

First Submitted That Met QC Criteria

January 15, 2019

First Posted (Actual)

January 16, 2019

Study Record Updates

Last Update Posted (Actual)

July 31, 2024

Last Update Submitted That Met QC Criteria

July 30, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-A03229-44

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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