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NCT Number: NCT03806959

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

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, ..).

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Key information

Conditions

Irritable Bowel Syndrome With Diarrhea

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de Recherche sur Volontaires (CRV), Hospital Avicenne

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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)

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

    Time frame: 1 month

    Number of completed questionnaire

Sponsors and collaborators

Lead sponsor

Hospital Avicenne

Other

Collaborators

  • Adeprina

Registry information

Official study title

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

Acronym: IPSILON

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jan 16, 2019
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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