DyspepsiaNCT03479528
The Predictive Value of Alarm Symptoms in Patients With Dyspepsia Based on Roman IV
An observational study of Dyspepsia, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
Trial summary
Functional dyspepsia is one of the most common gastrointestinal disorders (FGIDs) encountered in clinical practice.Clinical diagnosis is notoriously unreliable in diagnosing the underlying cause of dyspepsia,but a number of alarm features have been suggested as indicating patients at higher risk for serious disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspepsia
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 31 Jan 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 March 2018 to August 2018 ，patient went to the Gastroenterology clinics of the second affiliated hospital of xi'an jiaotong university, Xijing Hospital, Tangdu Hospital, Xi'an No.3 Hospital, and received gastroscopy.
Who may be able to join
- Aged 18 years and older;
- Presence of dyspeptic symptoms according with Rome IV criteria (Discomfort was characterized by the presence of one or more symptoms that included bothersome postprandial fullness, bothersome early satiation, bothersome epigastric pain, bothersome epigastric burning, Symptoms had to be present for at least 3 months within the preceding 6 months);
- From March 2018 to January 2019, patient went to the Gastroenterology clinics of the second affiliated hospital of xi'an jiaotong university, Xijing Hospital, Tangdu Hospital, Xi'an No.3 Hospital, and received gastroscopy;
- Upper abdominal ultrasonography, blood routine examination, liver function test were conducted within six months.
Who cannot join
- History of esophagitis or ulcer disease or other organic upper gastrointestinal disease, pancreaticobiliary disease, metabolic disease(abnormal thyroid function, diabetes );
- Were pregnant, might become pregnant, or were lactating;
- Major abdominal surgery;
- Severe neurological disorder, psychological diseases; or with severe hepatic, renal or respiratory dysfunction;
- Known or suspected liver dysfunction, including NASH, HBV or HCV-related hepatitis;
- History of gastroscope within 1 year;
- Current antidepressant, steroids or NSAID use; (7) Patients who had only reflux-related symptoms or who had predominantly reflux-related symptoms; (8) Not willing to participate in the study.
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
Zhongcao Wei, MD, +86-29-18700932477, 1977816504@qq.com
About this study
Functional dyspepsia is one of the most common gastrointestinal disorders (FGIDs) encountered in clinical practice.Clinical diagnosis is notoriously unreliable in diagnosing the underlying cause of dyspepsia,but a number of alarm features have been suggested as indicating patients at higher risk for serious disease. The predictive value of alarm symptoms still require more researches. Rome IV introduced more precisely define the minimal thresholds for frequency and severity of each individual symptom, primarily for scientific purposes,but data still need to be collected to define thresholds based on the frequency and/or severity of symptoms that impair quality of life.A cross-sectional study was conducted to assess the predictive value of alarm symptoms in patients with dyspepsia based on Roman IV.Through endoscopy results to determine whether dyspepsia is organic or functional, benign or malignant, through contacts with the basic data, to determine the alarm symptoms
Read the detailed description
Functional dyspepsia is one of the most common gastrointestinal disorders (FGIDs) encountered in clinical practice. Functional dyspepsia is a clinical syndrome characterized by chronic and recurrent gastroduodenal symptoms in the absence of any organic or metabolic disease that is likely to explain the symptoms.Functional dyspepsia has a high incidence in the population.Clinical diagnosis is notoriously unreliable in diagnosing the underlying cause of dyspepsia,but a number of alarm features have been suggested as indicating patients at higher risk for serious disease.However, previous studies noted that the sensitivity of alarm features for predicting cases with upper GI malignancies is unsatisfactory. The predictive value of alarm symptoms still require more researches. Rome IV was introduced in 2016. Rome IV introduced more precisely define the minimal thresholds for frequency and severity of each individual symptom, primarily for scientific purposes,but data still need to be collected to define thresholds based on the frequency and/or severity of symptoms that impair quality of life.A cross-sectional study was conducted to assess the predictive value of alarm symptoms in patients with dyspepsia based on Roman IV.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, Xi'an No.3 Hospital, and received investigation.Inclusion criteria included:Symptoms of upper digestive tract for more than 6 months or 3 monthes（postprandial fullness, early satiation,epigastric pain, and epigastric burning）;Older than 18;From March 2018 to January 2011，received gastroscope and upper abdominal B ultrasound examination;agreeing the informed consent.Data collection:Basic information：name, age, height, weight, gender, marriage;Dyspepsia: symptoms of indigestion, duration of indigestion, and weekly incidence of indigestion;Abnormal symptoms: weight loss, anemia, anorexia, vomiting, blackstool, dysphagia;Lifestyle habits: spicy food, smoking, drinking, sleep quality, daily exercise time;Family history, helicobacter pylori infection, abdominal color ultrasound results,Cost.Through endoscopy results to determine whether dyspepsia is organic or functional, 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
- Dyspepsia
- Keywords
- Dyspepsia,alarm symptoms，Roman IV
- Medical subject headings
- Dyspepsia
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 |
|---|---|---|
| Dyspepsia | 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, Xi'an No.3 Hospital, and received investigation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of organic dyspepsia.
To collect the results of gastroscopy in patients who meet inclusion criteria, and to calculate the incidence of organic dyspepsia to analyze the predictive value of alarm symptoms.
Measured: 3 months
Secondary outcomes (1)
The incidence of gastric cancer
To collect the results of gastroscopy in patients who meet inclusion criteria, and to calculate the incidence of gastric cancer to analyze the predictive value of alarm symptoms.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start1 Mar 2018
- Primary completion31 Jan 2019 (estimated)
- Study completion31 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DyspepsiaStudies 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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Collaborators
- Xijing Hospital, Tang-Du Hospital, Xi'an No.3 Hospital
- Responsible party
- Sponsor
- Investigators
- Jinhai Wang, MD, Study director, The Second Affiliated Hospital of Xi'an Jiaotong University,Xi'an, Shaanxi, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479528
- Sponsor's protocol ID
- 2018013
- Status last verified
- Feb 2018
- First submitted
- 8 Mar 2018
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wei Z, Yang Q, Yang Q, Yang J, Tantai X, Xing X, Xiao C, Pan Y, Liu N, Wang J. Rome III, Rome IV, and Potential Asia Symptom Criteria for Functional Dyspepsia Do Not Reliably Distinguish Functional From Organic Disease. Clin Transl Gastroenterol. 2020 Dec;11(12):e00278. doi: 10.14309/ctg.0000000000000278.
PubMed 33512804Wei ZC, Yang Q, Yang Q, Yang J, Tantai XX, Xing X, Xiao CL, Pan YL, Wang JH, Liu N. Predictive value of alarm symptoms in patients with Rome IV dyspepsia: A cross-sectional study. World J Gastroenterol. 2020 Aug 14;26(30):4523-4536. doi: 10.3748/wjg.v26.i30.4523.
PubMed 32874062
Study at a glance
From the registry record, last updated by the sponsor on 14 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 Dyspepsia Based on Roman IV
- ClinicalTrials.gov ID
- NCT03479528
- Acronym / sponsor ID
- 2018013
- Conditions
- Dyspepsia
- Keywords
- Dyspepsia,alarm symptoms，Roman IV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Xijing Hospital, Tang-Du Hospital, Xi'an No.3 Hospital
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Jan 2019 (estimated)
- Study completion
- 31 Jan 2019 (estimated)
- First posted
- 27 Mar 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.
Functional dyspepsia is one of the most common gastrointestinal disorders (FGIDs) encountered in clinical practice.Clinical diagnosis is notoriously unreliable in diagnosing the underlying cause of dyspepsia,but a number of alarm features have been suggested as indicating patients at higher risk for serious disease. The predictive value of alarm symptoms still require more researches. Rome IV introduced more precisely define the minimal thresholds for frequency and severity of each individual symptom, primarily for scientific purposes,but data still need to be collected to define thresholds based on the frequency and/or severity of symptoms that impair quality of life.A cross-sectional study was conducted to assess the predictive value of alarm symptoms in patients with dyspepsia based on Roman IV.Through endoscopy results to determine whether dyspepsia is organic or functional, benign or malignant, through contacts with the basic data, to determine the alarm symptoms
Detailed description
Functional dyspepsia is one of the most common gastrointestinal disorders (FGIDs) encountered in clinical practice. Functional dyspepsia is a clinical syndrome characterized by chronic and recurrent gastroduodenal symptoms in the absence of any organic or metabolic disease that is likely to explain the symptoms.Functional dyspepsia has a high incidence in the population.Clinical diagnosis is notoriously unreliable in diagnosing the underlying cause of dyspepsia,but a number of alarm features have been suggested as indicating patients at higher risk for serious disease.However, previous studies noted that the sensitivity of alarm features for predicting cases with upper GI malignancies is unsatisfactory. The predictive value of alarm symptoms still require more researches. Rome IV was introduced in 2016. Rome IV introduced more precisely define the minimal thresholds for frequency and severity of each individual symptom, primarily for scientific purposes,but data still need to be collected to define thresholds based on the frequency and/or severity of symptoms that impair quality of life.A cross-sectional study was conducted to assess the predictive value of alarm symptoms in patients with dyspepsia based on Roman IV.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, Xi'an No.3 Hospital, and received investigation.Inclusion criteria included:Symptoms of upper digestive tract for more than 6 months or 3 monthes（postprandial fullness, early satiation,epigastric pain, and epigastric burning）;Older than 18;From March 2018 to January 2011，received gastroscope and upper abdominal B ultrasound examination;agreeing the informed consent.Data collection:Basic information：name, age, height, weight, gender, marriage;Dyspepsia: symptoms of indigestion, duration of indigestion, and weekly incidence of indigestion;Abnormal symptoms: weight loss, anemia, anorexia, vomiting, blackstool, dysphagia;Lifestyle habits: spicy food, smoking, drinking, sleep quality, daily exercise time;Family history, helicobacter pylori infection, abdominal color ultrasound results,Cost.Through endoscopy results to determine whether dyspepsia is organic or functional, 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 |
|---|---|---|
| Dyspepsia | – | –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, Xi'an No.3 Hospital, and received investigation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From March 2018 to August 2018 ，patient went to the Gastroenterology clinics of the second affiliated hospital of xi'an jiaotong university, Xijing Hospital, Tangdu Hospital, Xi'an No.3 Hospital, and received gastroscopy.
Key inclusion criteria (4 listed)
- Aged 18 years and older;
- Presence of dyspeptic symptoms according with Rome IV criteria (Discomfort was characterized by the presence of one or more symptoms that included bothersome postprandial fullness, bothersome early satiation, bothersome epigastric pain, bothersome epigastric burning, Symptoms had to be present for at least 3 months within the preceding 6 months);
- From March 2018 to January 2019, patient went to the Gastroenterology clinics of the second affiliated hospital of xi'an jiaotong university, Xijing Hospital, Tangdu Hospital, Xi'an No.3 Hospital, and received gastroscopy;
- Upper abdominal ultrasonography, blood routine examination, liver function test were conducted within six months.
Key exclusion criteria (7 listed)
- History of esophagitis or ulcer disease or other organic upper gastrointestinal disease, pancreaticobiliary disease, metabolic disease(abnormal thyroid function, diabetes );
- Were pregnant, might become pregnant, or were lactating;
- Major abdominal surgery;
- Severe neurological disorder, psychological diseases; or with severe hepatic, renal or respiratory dysfunction;
- Known or suspected liver dysfunction, including NASH, HBV or HCV-related hepatitis;
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 dyspepsia.
Time frame: 3 months
To collect the results of gastroscopy in patients who meet inclusion criteria, and to calculate the incidence of organic dyspepsia to analyze the predictive value of alarm symptoms.
1 secondary outcome
The incidence of gastric cancer
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
- Derived from this study: PubMed 33512804Wei Z, Yang Q, Yang Q, Yang J, Tantai X, Xing X, Xiao C, Pan Y, Liu N, Wang J. Rome III, Rome IV, and Potential Asia Symptom Criteria for Functional Dyspepsia Do Not Reliably Distinguish Functional From Organic Disease. Clin Transl Gastroenterol. 2020 Dec;11(12):e00278. doi: 10.14309/ctg.0000000000000278.
- Derived from this study: PubMed 32874062Wei ZC, Yang Q, Yang Q, Yang J, Tantai XX, Xing X, Xiao CL, Pan YL, Wang JH, Liu N. Predictive value of alarm symptoms in patients with Rome IV dyspepsia: A cross-sectional study. World J Gastroenterol. 2020 Aug 14;26(30):4523-4536. doi: 10.3748/wjg.v26.i30.4523.
- Individual participant dataSharing planned: No
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Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia
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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.
Jinhai Wang, MD study director
The Second Affiliated Hospital of Xi'an Jiaotong University,Xi'an, Shaanxi, 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 Dyspepsia, 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 4 inclusion and 7 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 14 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 dyspepsia. (time frame: 3 months). 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 NCT03479528, which also lists 2 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 14 Jan 2019.