Irritable Bowel Syndrome With DiarrheaIPSILONNCT03806959
Interest of Pan Capsule in Symptomatic Patients Suspected of Irritable Bowel Syndrome Requiring Colonoscopy
A study testing Pan Capsule and colonoscopy in patients with IBS in people with Irritable Bowel Syndrome With Diarrhea, run by Hospital Avicenne at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Irritable Bowel Syndrome With Diarrhea
- What is being tested?
- Pan Capsule and colonoscopy in patients with IBS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 7 Nov 2018to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Recherche sur Volontaires (CRV), Hospital Avicenne
Bobigny, Île-de-France Region, 93000
About this study
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
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.
Read more
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
- Being tested
- Pan Capsule and colonoscopy in patients with IBS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pan Capsule and colonoscopy in patients with IBSOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pan Capsule and colonoscopy | Experimental | Every patient will have both Pan Capsule and colonoscopy examinations Descriptive study only Receives: Other: Pan Capsule and colonoscopy in patients with IBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 month
Secondary outcomes (2)
Acceptability of the pan-capsule, preference of one of the carried out explorations (pan-capsule or iléo-colonoscopy).
Index of acceptability (visual analogy scale)
Measured: 1 month
Acceptability to complete the questionnaires (number of completed questionnaires).
Number of completed questionnaire
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start7 Nov 2018
- Primary completion6 May 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel Syndrome With DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Avicenne
- Sponsor type
- University, hospital or other
- Collaborators
- Adeprina
- Responsible party
- Principal investigator, Robert Benamouzig, Hospital Avicenne
- Investigators
- Robert BENAMOUZIG, Professor, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806959
- Sponsor's protocol ID
- 2017-A03229-44
- Acronym
- IPSILON
- Status last verified
- Jul 2024
- First submitted
- 10 Jan 2019
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25728697Mearin 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.
PubMed 27144627Gralnek 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.
PubMed 10982758Canavan 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.
PubMed 25199904Corsetti 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.
PubMed 25424580Andresen 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.
PubMed 25653858Quigley EM. Overlapping irritable bowel syndrome and inflammatory bowel disease: less to this than meets the eye? Ther Adv Gastroenterol. 2016 Mar;9(2):199-212. doi: 10.1177/1756283X15621230.
PubMed 26929782Spiller 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.
PubMed 20152787Lieberman 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.
PubMed 16301030Chey 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.
PubMed 20179696Ishihara 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.
PubMed 22460220Patel 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.
PubMed 25636675Soubieres 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.
PubMed 28839818Pimentel 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.
PubMed 27261204
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03806959
- Acronym / sponsor ID
- IPSILON / 2017-A03229-44
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Hospital AvicenneUniversity, hospital or other
- Collaborators
- Adeprina
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 6 May 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 16 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- every patient will have both pan-capsule and colonoscopy. comparison intra-group between lesions found by the two examinations.
| Arm | Type | Receives |
|---|---|---|
| Pan Capsule and colonoscopy | Experimental | Other: Pan Capsule and colonoscopy in patients with IBSEvery patient will have both Pan Capsule and colonoscopy examinations Descriptive study only |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pan Capsule and colonoscopy in patients with IBSEvery 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. | Other | Pan Capsule and colonoscopy |
Primary outcome
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).
2 secondary outcomes
Acceptability of the pan-capsule, preference of one of the carried out explorations (pan-capsule or iléo-colonoscopy).
Time frame: 1 month
Acceptability to complete the questionnaires (number of completed questionnaires).
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Background: PubMed 25728697Le 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.
- Background: PubMed 27144627Mearin 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.
- Background: PubMed 10982758Gralnek 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.
- Background: PubMed 25199904Canavan 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.
- Background: PubMed 25424580Corsetti 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.
- Background: PubMed 25653858Andresen 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.
- Background: PubMed 26929782Quigley EM. Overlapping irritable bowel syndrome and inflammatory bowel disease: less to this than meets the eye? Ther Adv Gastroenterol. 2016 Mar;9(2):199-212. doi: 10.1177/1756283X15621230.
- Background: PubMed 20152787Spiller 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.
- Background: PubMed 16301030Lieberman 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.
- Background: PubMed 20179696Chey 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.
- Background: PubMed 22460220Ishihara 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.
- Background: PubMed 25636675Patel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert BENAMOUZIG, Professor principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pan Capsule and colonoscopy in patients with IBS in people with Irritable Bowel Syndrome With Diarrhea, run by Hospital Avicenne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with digestive pathology and / or significant gastrointestinal lesion. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03806959, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.