The Predictive Value of Alarm Symptoms in Patients With Irritable Bowel Syndrome Based on Rome IV

NCT03620994 | Unknown

• 1 other identifier: 20188517
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome; alarm symptoms; Roman IV

Outcome Measures

Primary Outcomes (1)

• The incidence of organic bowel diseases

  To collect the results of colonoscopy in patients who meet inclusion criteria, and to calculate the incidence of organic bowel diseases to analyze the predictive value of alarm symptoms.

  6 months

Secondary Outcomes (1)

• The incidence of organic bowel diseases in different subtypes of IBS

  6 months

Study Arms (1)

Irritable Bowel Syndrome

All patients who were satisfied with the inclusion criteria and exclusion criteria in the department of the second affiliated hospital of Xi'an JiaoTong University, Xijing Hospital ,Tangdu Hospital or affiliated hospital of Northwest University received investigation. Patients who participate in the study are determined on their own initiative, with full understanding and informedness.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

From August 2018 to March 2019, patients went to the Gastroenterology clinics of the second affiliated hospital of Xi'an JiaoTong University, Xijing Hospital ,Tangdu Hospital or affiliated hospital of Northwest University who met the inclusion criteria were followed up.Subjects are voluntarily involved in the study, provided that they are fully understood and informed. The patients included in this study are all patients who underwent colonoscopy and signed an informed consent form for colonoscopy.

You may qualify if:

• Presence of Irritable bowel syndrome symptoms，that is，recurrent abdominal pain, on average, at least 1 day per week in the last 3 months, associated with 2 or more of the following criteria:
• Related to defecation;
• Associated with a change in frequency of stool;
• Associated with a change in form (appearance) of stool.
• （Criteria fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis.）
• Aged 18 years and older;
• August 2018 to March 2019, patients went to the Gastroenterology clinics of the second affiliated hospital of Xi'an JiaoTong University, Xijing Hospital ,Tangdu Hospital or affiliated hospital of Northwest University , and received Colonoscopy;
• Blood routine examination, fecal routine examination, and fecal occult blood test were conducted within 6 months.

You may not qualify if:

• Previously diagnosed with diseases that better explain the participant's IBS symptoms (e.g. celiac disease, colorectal cancer, inflammatory bowel disease, microscopic colitis, lactose intolerance, bile acid malabsorption, intestinal tuberculosis, diverticulosis, ischemic enteritis, etc.);
• Metabolic disease: uncontrolled thyroid disease and diabetes;
• Severe neurological and psychiatric disorders, which may impede conduct of the clinical trial. These disorders include but are not limited to major depression with a high risk of suicidal behavior (i.e. intent or plan), alcohol or substance abuse/dependence, a lifetime history of psychosis;
• Participant has an unstable severe extraintestinal medical condition (such as heart, liver, kidney and respiratory failure) with immediate or foreseeable treatment needs;
• Previous major abdominal surgery that would have resulted in significant changes in the anatomy or physiology of the gastrointestinal tract, which can fully explain GI symptoms. Note: appendectomy, cholecystectomy, endoscopic polypectomy, endoscopic mucosal resection and endoscopic submucosal resection are not excluded criteria;
• Were pregnant, might become pregnant, or were lactating;
• Colonoscopy for structural evaluation of the GI tract in the past 6 months due to their IBS symptoms;
• Taking anti-anxiety, anti-depressant drugs or intestinal sensitive antibiotics recently;
• A current infection or infection of any type within the 2 weeks prior to evaluation that would obscure the presentation of IBS symptoms, in which case the assessment can be delayed until 2 weeks after full recovery;
• Currently diagnosed malignancy, with exception of localized basal or squamous cell carcinomas of the skin which is completely removed. The so-called "current" means that the diagnosis of any malignancy (except basal cells or squamous cell carcinoma) that is active occurs within the first 12 months of enrollment;
• Refusal to participate in this study or who cannot follow the research requirements for various reasons.

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead

Study Sites (1)

The second affiliated hospital of xi'an jiaotong university

Xi’an, Shanxi, 710004, China

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Jinhai Wang, MD

  The Second Affiliated Hospital of Xi'an Jiaotong University,Xi'an, Shanxi, China

  STUDY DIRECTOR

Central Study Contacts

Jinhai Wang, MD

CONTACT

+86-29-18700932477; jinhaiwang@hotmail.com

Yang Qian

CONTACT

+86-29-15091893818; 1565952553@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2018
• First Posted: August 8, 2018
• Study Start: August 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: January 11, 2019

Record last verified: 2018-08

Locations

CN (1)