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NCT03620994
The Predictive Value of Alarm Symptoms in Patients With Irritable Bowel Syndrome Based on Rome IV
trial in Irritable Bowel Syndrome in 300 participants. Status unknown.
1 March 2019
Quick facts
| Lead sponsor | Second Affiliated Hospital of Xi'an Jiaotong University |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 300 |
| Start date | 1 August 2018 |
| Primary completion | 1 March 2019 |
| Estimated completion | 1 March 2019 |
| Sites | 1 location across China |
Conditions studied
- Irritable Bowel Syndrome — all drugs for Irritable Bowel Syndrome →
Sponsor
Second Affiliated Hospital of Xi'an Jiaotong University
Who can join
18 and older, any sex, with Irritable Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Irritable bowel syndrome (IBS) is one of the most commonly diagnosed functional bowel disorders (FBD). IBS is diagnosed by symptom-based criteria，while the available literature suggests that symptom-based diagnostic algorithms, which often used for clinical and research studies, have poor sensitivity. Although diagnostic algorithms can discriminate IBS from health or upper gastrointestinal tract conditions, studies do not provide convincing evidence that the criteria can discriminate IBS from organic disease of the colon. Rectal bleeding, anemia, weight loss, fever, family history of colon cancer, and age above 50 years are considered the warning signs of severe gastrointestinal disease. Colonoscopy is the most direct way to rule out organic colonic diseases. There is no consensus so far on whether patients with suspected IBS lacking warning signs need colonoscopy or not. In 2016, the Rome IV criteria was updated and published. However, there are few studies on the clinical practice based on Rome IV. The value of alarm symptoms in discriminating organic disease from functional disorders remains uncertain and further research is needed. To evaluate the predictive value of alarm symptoms of IBS patients based on Roman IV, the investigators designed this cross-sectional study.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03620994 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Second Affiliated Hospital of Xi'an Jiaotong University
- Last refreshed: 11 January 2019
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