Non-erosive Gastroesophageal Reflux DiseaseFGISP-RCTNCT01047800
Functional Gastrointestinal Disorder Screening Program - A Randomized Controlled Trial
A study testing Counseling in people with Non-erosive Gastroesophageal Reflux Disease and Functional Dyspepsia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Background: Functional gastrointestinal disorder (FGID) is the most common gastrointestinal disease in daily clinical practice. The disease is symptomatic but has no identifiable cause by standard diagnostic tests such as endoscopy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Non-erosive Gastroesophageal Reflux Disease, Functional Dyspepsia, Irritable Bowel Syndrome
- What is being tested?
- Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteHong Kong
- Study dates
- Jan 2010to Dec 2016
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Present with symptoms suggestive of any of the following FGID according to Rome III Classification:
- Non-erosive gastroesophageal reflux disease (NERD) Weekly symptoms of heartburn or acid regurgitation of moderate severity for at least 6 months
- Functional dyspepsia (FD) Weekly symptoms of epigastric burning sensation, early satiety or postprandial fullness for at least 6 months
- Irritable bowel syndrome (IBS)
- Symptoms of abdominal pain or discomfort of at least 3 times a month, in the last 6 months, associated with 2 or more of the following:
- Improvement with defecation
- Onset associated with a change in frequency of stool
- Onset associated with a change in form (appearance) of stool
Who cannot join
- Erosive esophagitis (Still eligible for IBS patients)
- Peptic ulcer (Still eligible for IBS patients after complete ulcer healing)
- H. pylori positive
- Organic causes of symptoms, including malignancy, abnormal thyroid function, and inflammatory bowel disease.
- Previous gastric surgery
- Pregnancy
- Illiterate
- Unable to sign the written consent form • Abdominal surgery within one year prior to joining the program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Counseling for Functional Gastrointestinal Disorder Patients: A Double-blind Randomized Controlled Trial
Background:
Functional gastrointestinal disorder (FGID) is the most common gastrointestinal disease in daily clinical practice. The disease is symptomatic but has no identifiable cause by standard diagnostic tests such as endoscopy. It is characterized by its frequent relapses and thus the disease causes a significant level of stress and anxiety to patients. Due to the complexity and chronicity of the disease, it is believed that appropriate counseling on the nature and management of the disease is necessary to decrease patient's anxiety level and improve quality of life.
Read more
Indication:
Patients who have symptoms suggestive of FGID including non-erosive gastroesophageal reflux disease (NERD), functional dyspepsia (FD) or irritable bowel syndrome (IBS).
Aim:
To validate the effectiveness of counseling in patients suffering from FGID.
Method:
Patients recruited to the study will follow the usual management of patients attending the Gastroenterology specialty clinic in Prince of Wales Hospital. Standard blood tests and endoscopy will be performed. Standard medication will be given to the patients for 8 weeks after endoscopy and the patients will come back to the specialty clinic for a final visit.
The patient will be given an "on-demand follow up within 1 year" option at final visit. The patient will decide if he/she wants to come back to our specialty clinic to follow up his/her problem within one year.
Follow-up after Final Visit Follow-up questionnaires will be mailed to patients 6 months, 1 and 2 years after Final visit.
Randomization:
All the patients will be randomized into two groups in First Visit: 1) Control group, and 2) Counseling group. Both groups of patients will follow the above protocol, except that 2 extra counseling sessions will be arranged for the Counseling group immediately after visiting the physician.
Read the detailed description
Patients recruited to the study will follow the usual management of patients attending the Gastroenterology specialty clinic in Prince of Wales Hospital, along with the following protocol:
First Visit
- Patient signs written consent
- Attending physician manages patient as usual
- Blood tests will be arranged for patient:
- FD \& NERD patients: CBC w/ differential count, LFT, TFT, random glucose
- IBS patients: CBC w/ differential count, LFT, TFT, ESR, C-reactive protein
- Patient completes questionnaires
Endoscopy Visit
- Endoscopy examinations
- FD \& NERD patients: oesophagogastroduodenoscopy (OGD) with rapid urea test (RUT) and biopsy of antrum sample for histology to check h. pylori status
- IBS patients: colonoscopy
- If no organic causes are found to explain for FGI symptoms, the following standard medication will be prescribed for 8 weeks:
FD: Pantoprazole 40mg daily; GERD: Pantoprazole 40mg daily; IBS: Mebeverine 135mg tid PRN before meal, Loperamide 4mg tid PRN (for diarrhea), Metamucil 2 teaspoon bid (for constipation).
Final Visit (8 weeks after endoscopy visit)
- Attending physician manages patient as usual
- Printout of investigation (endoscopy, blood tests) reports given to patient
- Patient completes questionnaires
The patient will be given an "on-demand follow up within 1 year" option at this visit. The patient will decide if he/she wants to come back to our specialty clinic to follow up his/her problem within one year. If the patient does not come back during this period, his/her case will be closed and a new referral will be required if he/she wants to be taken care by the specialty again.
Follow-up after Final Visit:
Follow-up questionnaires will be mailed to patients 6 months, 1 and 2 years after Final visit.
Randomization:
All the patients will be randomized into two groups in First Visit: 1) Control group, and 2) Counseling group. Both groups of patients will follow the above protocol, except that 2 extra counseling sessions will be arranged for the Counseling group immediately after visiting the physician:
Counseling at first visit:
- Contents include: prevalence of FGID in Hong Kong, chronicity nature of the disease, negative endoscopy result to be expected, time to answer patient's questions
Counseling at final visit:
- Contents include: prevalence of FGID in Hong Kong (reinforcement), chronicity nature of the disease (reinforcement), explanation of the endoscopy result, management of disease via lifestyle modification, use of medication, need for further or repeated investigation, time to answer patient's questions.
A research personnel who has been working with patients with FGID for at least one year will be responsible for the counseling service.
The random allocation sequence will be obtained from a computer-generated list of random numbers in blocks of 10 supplied by a trial statistician. Concealed allocation is achieved by an independent research staff who assigns intervention group according to consecutive numbers in sealed envelopes. The patients will be invited to participate in the study to assess 1 of 2 potentially helpful interventions. They will be explained that the relative effectiveness of both interventions are unproven and may or may not be beneficial.
In this study, the patients, attending physicians and endoscopes will all be blinded to the randomized arm that the patients are assigned to. The nature of the two arms will also be blinded to them. This arrangement is essential in clinical trials comparing different services or managing strategies and is clearly specified in the Patient Information Sheet.
- Conditions
- Non-erosive Gastroesophageal Reflux Disease, Functional Dyspepsia, Irritable Bowel Syndrome
- Being tested
- Counseling
- Keywords
- Functional gastrointestinal disorder, GERD, reflux, irritable bowel syndrome, Functional dyspepsia, postprandial fullness, counseling, service
- Medical subject headings
- Irritable Bowel Syndrome, Gastrointestinal Diseases, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingBehavioural
Two extra counseling sessions will be arranged for the Counseling group immediately after visiting the physician in First and Final visits. Each session lasts for about 15 minutes with the following content:
First visit: prevalence of FGID in Hong Kong, chronicity nature of the disease, negative endoscopy result to be expected, time to answer patient's questions
Final visit : prevalence of FGID in Hong Kong (reinforcement), chronicity nature of the disease (reinforcement), explanation of the endoscopy result, management of disease via lifestyle modification, use of medication, need for further or repeated investigation, time to answer patient's questions.
| Study group | Role | What they receive |
|---|---|---|
| Counseling group | Experimental | Two extra counseling sessions will be arranged for the Counseling group immediately after visiting the physician Receives: Behavioral: Counseling |
| Control | No intervention | Usual management in GI specialty clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-efficacy and decrease in psychological distress measured by Health status and management scales and Patient Health Questionnaire (PHQ)
Measured: 6 months after Final visit
Rate of attendance to "on-demand follow up within 1 year" option given at Final visit
Measured: 1 year after Final visit
Secondary outcomes (4)
Frequency of doctor's visits
Measured: 1 and 2 years after Final visit
Use of emergency service
Measured: 1 and 2 years after Final visit
Self-rated health measured by Health status and management scales
Measured: 6 months, 1 and 2 years after Final visit
Social/role activities limitation measured by Health status and management scales
Measured: 6months, 1 and 2 years after Final visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionMay 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-erosive Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Che-Yuen Wu, Chinese University of Hong Kong
- Investigators
- Justin C.Y. Wu, MBChB(CUHK), Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047800
- Sponsor's protocol ID
- FGISP-RCT
- Acronym
- FGISP-RCT
- Status last verified
- Apr 2017
- First submitted
- 12 Jan 2010
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Counseling for Functional Gastrointestinal Disorder Patients: A Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01047800
- Acronym / sponsor ID
- FGISP-RCT / FGISP-RCT
- Conditions
- Non-erosive Gastroesophageal Reflux Disease, Functional Dyspepsia, Irritable Bowel Syndrome
- Keywords
- Functional gastrointestinal disorder, GERD, reflux, irritable bowel syndrome, Functional dyspepsia, postprandial fullness, counseling, service
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Jan 2010 (estimated)
- 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.
Background:
Functional gastrointestinal disorder (FGID) is the most common gastrointestinal disease in daily clinical practice. The disease is symptomatic but has no identifiable cause by standard diagnostic tests such as endoscopy. It is characterized by its frequent relapses and thus the disease causes a significant level of stress and anxiety to patients. Due to the complexity and chronicity of the disease, it is believed that appropriate counseling on the nature and management of the disease is necessary to decrease patient's anxiety level and improve quality of life.
Indication:
Patients who have symptoms suggestive of FGID including non-erosive gastroesophageal reflux disease (NERD), functional dyspepsia (FD) or irritable bowel syndrome (IBS).
Aim:
To validate the effectiveness of counseling in patients suffering from FGID.
Method:
Patients recruited to the study will follow the usual management of patients attending the Gastroenterology specialty clinic in Prince of Wales Hospital. Standard blood tests and endoscopy will be performed. Standard medication will be given to the patients for 8 weeks after endoscopy and the patients will come back to the specialty clinic for a final visit.
The patient will be given an "on-demand follow up within 1 year" option at final visit. The patient will decide if he/she wants to come back to our specialty clinic to follow up his/her problem within one year.
Follow-up after Final Visit Follow-up questionnaires will be mailed to patients 6 months, 1 and 2 years after Final visit.
Randomization:
All the patients will be randomized into two groups in First Visit: 1) Control group, and 2) Counseling group. Both groups of patients will follow the above protocol, except that 2 extra counseling sessions will be arranged for the Counseling group immediately after visiting the physician.
Detailed description
Patients recruited to the study will follow the usual management of patients attending the Gastroenterology specialty clinic in Prince of Wales Hospital, along with the following protocol:
First Visit
- Patient signs written consent
- Attending physician manages patient as usual
- Blood tests will be arranged for patient:
- FD \& NERD patients: CBC w/ differential count, LFT, TFT, random glucose
- IBS patients: CBC w/ differential count, LFT, TFT, ESR, C-reactive protein
- Patient completes questionnaires
Endoscopy Visit
- Endoscopy examinations
- FD \& NERD patients: oesophagogastroduodenoscopy (OGD) with rapid urea test (RUT) and biopsy of antrum sample for histology to check h. pylori status
- IBS patients: colonoscopy
- If no organic causes are found to explain for FGI symptoms, the following standard medication will be prescribed for 8 weeks:
FD: Pantoprazole 40mg daily; GERD: Pantoprazole 40mg daily; IBS: Mebeverine 135mg tid PRN before meal, Loperamide 4mg tid PRN (for diarrhea), Metamucil 2 teaspoon bid (for constipation).
Final Visit (8 weeks after endoscopy visit)
- Attending physician manages patient as usual
- Printout of investigation (endoscopy, blood tests) reports given to patient
- Patient completes questionnaires
The patient will be given an "on-demand follow up within 1 year" option at this visit. The patient will decide if he/she wants to come back to our specialty clinic to follow up his/her problem within one year. If the patient does not come back during this period, his/her case will be closed and a new referral will be required if he/she wants to be taken care by the specialty again.
Follow-up after Final Visit:
Follow-up questionnaires will be mailed to patients 6 months, 1 and 2 years after Final visit.
Randomization:
All the patients will be randomized into two groups in First Visit: 1) Control group, and 2) Counseling group. Both groups of patients will follow the above protocol, except that 2 extra counseling sessions will be arranged for the Counseling group immediately after visiting the physician:
Counseling at first visit:
- Contents include: prevalence of FGID in Hong Kong, chronicity nature of the disease, negative endoscopy result to be expected, time to answer patient's questions
Counseling at final visit:
- Contents include: prevalence of FGID in Hong Kong (reinforcement), chronicity nature of the disease (reinforcement), explanation of the endoscopy result, management of disease via lifestyle modification, use of medication, need for further or repeated investigation, time to answer patient's questions.
A research personnel who has been working with patients with FGID for at least one year will be responsible for the counseling service.
The random allocation sequence will be obtained from a computer-generated list of random numbers in blocks of 10 supplied by a trial statistician. Concealed allocation is achieved by an independent research staff who assigns intervention group according to consecutive numbers in sealed envelopes. The patients will be invited to participate in the study to assess 1 of 2 potentially helpful interventions. They will be explained that the relative effectiveness of both interventions are unproven and may or may not be beneficial.
In this study, the patients, attending physicians and endoscopes will all be blinded to the randomized arm that the patients are assigned to. The nature of the two arms will also be blinded to them. This arrangement is essential in clinical trials comparing different services or managing strategies and is clearly specified in the Patient Information Sheet.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Counseling group | Experimental | Behavioral: CounselingTwo extra counseling sessions will be arranged for the Counseling group immediately after visiting the physician |
| Control | No intervention | –Usual management in GI specialty clinic |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Present with symptoms suggestive of any of the following FGID according to Rome III Classification:
- Non-erosive gastroesophageal reflux disease (NERD) Weekly symptoms of heartburn or acid regurgitation of moderate severity for at least 6 months
- Functional dyspepsia (FD) Weekly symptoms of epigastric burning sensation, early satiety or postprandial fullness for at least 6 months
- Irritable bowel syndrome (IBS)
- Symptoms of abdominal pain or discomfort of at least 3 times a month, in the last 6 months, associated with 2 or more of the following:
Key exclusion criteria (8 listed)
- Erosive esophagitis (Still eligible for IBS patients)
- Peptic ulcer (Still eligible for IBS patients after complete ulcer healing)
- H. pylori positive
- Organic causes of symptoms, including malignancy, abnormal thyroid function, and inflammatory bowel disease.
- Previous gastric surgery
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 |
|---|---|---|
| CounselingTwo extra counseling sessions will be arranged for the Counseling group immediately after visiting the physician in First and Final visits. Each session lasts for about 15 minutes with the following content: First visit: prevalence of FGID in Hong Kong, chronicity nature of the disease, negative endoscopy result to be expected, time to answer patient's questions Final visit : prevalence of FGID in Hong Kong (reinforcement), chronicity nature of the disease (reinforcement), explanation of the endoscopy result, management of disease via lifestyle modification, use of medication, need for further or repeated investigation, time to answer patient's questions. | Behavioural | Counseling group |
Primary outcome
Self-efficacy and decrease in psychological distress measured by Health status and management scales and Patient Health Questionnaire (PHQ)
Time frame: 6 months after Final visit
Rate of attendance to "on-demand follow up within 1 year" option given at Final visit
Time frame: 1 year after Final visit
4 secondary outcomes
Frequency of doctor's visits
Time frame: 1 and 2 years after Final visit
Use of emergency service
Time frame: 1 and 2 years after Final visit
Self-rated health measured by Health status and management scales
Time frame: 6 months, 1 and 2 years after Final visit
Social/role activities limitation measured by Health status and management scales
Time frame: 6months, 1 and 2 years after Final visit
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 26 Apr 2017.
- 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.
Justin C.Y. Wu, MBChB(CUHK) principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling in people with Non-erosive Gastroesophageal Reflux Disease and Functional Dyspepsia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 8 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 26 Apr 2017. 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 Hong Kong. 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?
Self-efficacy and decrease in psychological distress measured by Health status and management scales and Patient Health Questionnaire (PHQ) (time frame: 6 months after Final visit). The study lists 2 primary outcomes in all. 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 26 Apr 2017.