Irritable Bowel SyndromeNCT03620994
The Predictive Value of Alarm Symptoms in Patients With Irritable Bowel Syndrome Based on Rome IV
An observational study of Irritable Bowel Syndrome, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 1 Mar 2019
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The second affiliated hospital of xi'an jiaotong university
Xi’an, Shanxi, 710004
Jinhai Wang, MD, +86-29-18700932477, jinhaiwang@hotmail.com
Yang Qian, +86-29-15091893818, 1565952553@qq.com
About this study
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.
Read the detailed description
Functional bowel disorders (FBD) are a spectrum of chronic gastrointestinal (GI) disorders characterized by predominant symptoms or signs of abdominal pain bloating, distention, and/or bowel habit abnormalities, and the absence of obvious anatomic or physiologic abnormalities identified by routine diagnostic examinations, as deemed clinically appropriate. Irritable bowel syndrome (IBS) is one of the most commonly diagnosed functional bowel disorders (FBD). characterized by abdominal pain and bowel dysfunction, presenting as constipation, diarrhea, or alternating periods of both. Incidence rates of IBS are seldom calculated, and prevalence estimates fluctuate both between and within countries. A literature review by Sperber and colleagues suggests that a global prevalence rate could not be estimated owing to the heterogeneity of the studies. The pooled prevalence rate that the investigators cited for North America, Europe, Australia, and New Zealand was 8.1%. While IBS is not associated with increased mortality rates, it represents a significant burden on affected patients and society as a result of direct medical costs, lost productivity, and reduced health-related quality of life.
The development and persistence of IBS symptoms are understood to be multifactorial. Consequently, diagnosis and treatment are complicated clinical endeavors. IBS is diagnosed by symptom-based criteria, initially proposed by Manning and subsequently modified and quantified in the Rome I, II, and III criteria. However, the available literature suggests that symptom based diagnostic algorithms, although 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. Therefore, in clinical practice, medical history should include evidence of organic disease (alarm symptoms) in addition to the main symptoms. 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. It is an agreement that patients who meet Rome criteria on IBS with warning signs are strongly advised to perform colonoscopy to rule out severe colonic diseases such as inflammatory bowel disease (IBD) and colorectal cancer . The diagnostic sensitivity of symptom criteria on irritable bowel syndrome without colonoscopy is not more than 69.7% in patients with suspected irritable bowel syndrome lacking warning signs. There is no consensus so far on whether patients with suspected IBS lacking warning signs need colonoscopy or not. However, the value of alarm symptoms in discriminating organic disease from functional disorders remains uncertain and further research is needed, especially as alarm features are common.
In 2016, the Rome IV criteria was updated and published, in which IBS involved several changes. And there are currently few clinical studies based on Roman IV. This cross-sectional study was designed to evaluate the predictive value of alarm symptoms for IBS and organic bowel diseases and the difference in predictive value between different subtypes based on Roman IV.
Data collection:Basic information: name, gender, race, age, BMI index (height, weight), marital status ;Gastrointestinal symptoms: IBS-related symptoms,change in form of stool,duration and incidence of symptoms; Alarm Symptoms: Rectal bleeding (black stool, blood on toilet paper), anemia, weight loss, fever, nocturnal symptoms; Lifestyle habits: eating habits (spicy stimulation, dietary fiber), smoking, drinking, sleep quality, daily exercise time; Family history: colorectal cancer, inflammatory bowel disease, celiac disease, etc; Personal history: history of gastrointestinal infections, life emergency events; Test results: laboratory test results,colonoscopy results. The investigators obtained relevant information through consultation, telephone follow-up, questionnaire follow-up.Through endoscopy results to determine organic or functional diseases, benign or malignant, through contacts with the basic data, to determine the alarm symptoms. Further more, this study was proved by the ethical committee of second hospital of Xi'an jiaotong university.
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, alarm symptoms, Roman IV
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
The incidence of organic bowel diseases in different subtypes of IBS
To collect the results of colonoscopy in patients who meet subtypes criteria, and to calculate the incidence of organic bowel diseases to compare the difference in predictive value of alarm symptoms for different subtypes of IBS.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start1 Aug 2018
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jinhai Wang, MD, Study director, The Second Affiliated Hospital of Xi'an Jiaotong University,Xi'an, Shanxi, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620994
- Sponsor's protocol ID
- 20188517
- Status last verified
- Aug 2018
- First submitted
- 5 Aug 2018
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of Alarm Symptoms in Patients With Irritable Bowel Syndrome Based on Rome IV
- ClinicalTrials.gov ID
- NCT03620994
- Acronym / sponsor ID
- 20188517
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, alarm symptoms, Roman IV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 8 Aug 2018 (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 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.
Detailed description
Functional bowel disorders (FBD) are a spectrum of chronic gastrointestinal (GI) disorders characterized by predominant symptoms or signs of abdominal pain bloating, distention, and/or bowel habit abnormalities, and the absence of obvious anatomic or physiologic abnormalities identified by routine diagnostic examinations, as deemed clinically appropriate. Irritable bowel syndrome (IBS) is one of the most commonly diagnosed functional bowel disorders (FBD). characterized by abdominal pain and bowel dysfunction, presenting as constipation, diarrhea, or alternating periods of both. Incidence rates of IBS are seldom calculated, and prevalence estimates fluctuate both between and within countries. A literature review by Sperber and colleagues suggests that a global prevalence rate could not be estimated owing to the heterogeneity of the studies. The pooled prevalence rate that the investigators cited for North America, Europe, Australia, and New Zealand was 8.1%. While IBS is not associated with increased mortality rates, it represents a significant burden on affected patients and society as a result of direct medical costs, lost productivity, and reduced health-related quality of life.
The development and persistence of IBS symptoms are understood to be multifactorial. Consequently, diagnosis and treatment are complicated clinical endeavors. IBS is diagnosed by symptom-based criteria, initially proposed by Manning and subsequently modified and quantified in the Rome I, II, and III criteria. However, the available literature suggests that symptom based diagnostic algorithms, although 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. Therefore, in clinical practice, medical history should include evidence of organic disease (alarm symptoms) in addition to the main symptoms. 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. It is an agreement that patients who meet Rome criteria on IBS with warning signs are strongly advised to perform colonoscopy to rule out severe colonic diseases such as inflammatory bowel disease (IBD) and colorectal cancer . The diagnostic sensitivity of symptom criteria on irritable bowel syndrome without colonoscopy is not more than 69.7% in patients with suspected irritable bowel syndrome lacking warning signs. There is no consensus so far on whether patients with suspected IBS lacking warning signs need colonoscopy or not. However, the value of alarm symptoms in discriminating organic disease from functional disorders remains uncertain and further research is needed, especially as alarm features are common.
In 2016, the Rome IV criteria was updated and published, in which IBS involved several changes. And there are currently few clinical studies based on Roman IV. This cross-sectional study was designed to evaluate the predictive value of alarm symptoms for IBS and organic bowel diseases and the difference in predictive value between different subtypes based on Roman IV.
Data collection:Basic information: name, gender, race, age, BMI index (height, weight), marital status ;Gastrointestinal symptoms: IBS-related symptoms,change in form of stool,duration and incidence of symptoms; Alarm Symptoms: Rectal bleeding (black stool, blood on toilet paper), anemia, weight loss, fever, nocturnal symptoms; Lifestyle habits: eating habits (spicy stimulation, dietary fiber), smoking, drinking, sleep quality, daily exercise time; Family history: colorectal cancer, inflammatory bowel disease, celiac disease, etc; Personal history: history of gastrointestinal infections, life emergency events; Test results: laboratory test results,colonoscopy results. The investigators obtained relevant information through consultation, telephone follow-up, questionnaire follow-up.Through endoscopy results to determine organic or functional diseases, benign or malignant, through contacts with the basic data, to determine the alarm symptoms. Further more, this study was proved by the ethical committee of second hospital of Xi'an jiaotong university.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.)
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence of organic bowel diseases
Time frame: 6 months
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.
1 secondary outcome
The incidence of organic bowel diseases in different subtypes of IBS
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
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.
Jinhai Wang, MD study director
The Second Affiliated Hospital of Xi'an Jiaotong University,Xi'an, Shanxi, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
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 8 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 11 Jan 2019. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinhai Wang, MD (+86-29-18700932477, jinhaiwang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of organic bowel diseases (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2019.