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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.
Full 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:
Patient completes questionnaires
Endoscopy Visit
Endoscopy examinations
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)
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:
Counseling at final visit:
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.
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Inclusion criteria
Present with symptoms suggestive of any of the following FGID according to Rome III Classification:
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:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
200 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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