Ignite Creation Date:
2024-05-05 @ 9:44 PM
Last Modification Date:
2024-10-26 @ 10:08 AM
Study NCT ID:
NCT00951431
Status:
COMPLETED
Last Update Posted:
2019-02-01
First Post:
2009-08-03
Brief Title:
Gastric Functions Proton Pump Inhibitor PPI Study
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Effect of Proton Pump Inhibitor on Gastric Emptying and Satiety Function in Patients With Functional Dyspepsia
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Functional dyspepsia is one of the most common digestive disorders The pathophysiology of functional dyspepsia is uncertain Proton pump inhibitor PPI has been recommended as the first line treatment for functional dyspepsia However the mechanism of symptom relief is unclear Most of the previous studies were performed on healthy volunteers who received only a very short course of PPI The correlation between symptom and gastric emptying is lacking in these studies
Demographic data and anthropometric measurements will be obtained for baseline assessment Patients are required to complete FGI Screening Questionnaire Functional dyspepsia symptom questionnaire gastroesophageal reflux disease GERD symptom questionnaire and irritable bowel syndrome IBS symptom questionnaire to have a thorough assessment of their GI symptoms 1 Satiety test and ghrelin profile and 2gastric emptying test will be arranged as two individual visits
After baseline investigations patients will be randomly assigned to either Nexium 20 mg daily or identical looking placebo for 8 weeks The patients will report their individual dyspeptic symptoms on weekly basis using a self-administered symptom questionnaire
Satiety test and ghrelin profile gastric emptying study will be repeated at the end of 8-week treatment
Hypothesis Long-term PPI relieves dyspeptic symptom through acceleration of gastric emptying rate
Demographic data and anthropometric measurements will be obtained for baseline assessment Patients are required to complete FGI Screening Questionnaire Functional dyspepsia symptom questionnaire gastroesophageal reflux disease GERD symptom questionnaire and irritable bowel syndrome IBS symptom questionnaire to have a thorough assessment of their GI symptoms 1 Satiety test and ghrelin profile and 2gastric emptying test will be arranged as two individual visits
After baseline investigations patients will be randomly assigned to either Nexium 20 mg daily or identical looking placebo for 8 weeks The patients will report their individual dyspeptic symptoms on weekly basis using a self-administered symptom questionnaire
Satiety test and ghrelin profile gastric emptying study will be repeated at the end of 8-week treatment
Hypothesis Long-term PPI relieves dyspeptic symptom through acceleration of gastric emptying rate
Detailed Description:
Background
Functional dyspepsia is one of the commonest digestive disorders It is a functional gastrointestinal disorder which is characterized by chronic recurrent epigastric symptoms such as pain burning and a variety of postprandial symptoms with absence of demonstrable organic pathology identified on investigations It has been reported that functional dyspepsia affects 10-30 of adult population
The pathophysiology of functional dyspepsia is uncertain It is thought to be a heterogeneous disorder Various factors have been implicated in the pathophysiology of functional dyspepsia It has been reported that delayed gastric emptying impaired proximal gastric accommodation visceral hypersensitivity and Helicobacter pylori gastritis play a role in development of functional dyspepsia However the correlation between these physiological abnormalities and symptomatology of functional dyspepsia is poor It is still controversial whether these pathophysiological factors are responsible for specific symptoms in functional dyspepsia
While mechanism of functional dyspepsia is unclear treatment has also been far from satisfactory Proton pump inhibitor has been recommended as the first line treatment for functional dyspepsia and it has been shown that the use of PPI is associated with a 14 reduction in risk of persistent dyspepsia compared to placebo However the mechanism of symptom relief is unclear While PPI exerts its effect primarily through suppression of acid-induced symptoms recent studies have shown that PPI may affect gastric motility function such as gastric volume gastric emptying and trigger of migratory motor complex Most of these studies were performed on healthy volunteers who received only a very short course of PPI The correlation between symptom and gastric emptying is lacking in these studies
Aims
To evaluate the effect of esomeprazole on gastric emptying
To evaluate the relationship between dyspeptic symptom and gastric emptying
Hypothesis
Long-term PPI relieves dyspeptic symptom through acceleration of gastric emptying rate
Study design
Double-blind randomized placebo-controlled trial
Baseline assessment
Demographic age gender
Anthropometric measurements body mass index height weight and waist circumference
FGI Screening Questionnaire v2 20090106 for screening of functional gastrointestinal disorder according to Rome III criteria
Functional dyspepsia symptom questionnaire FDSQ 20080416 an 8-item dyspeptic symptom score questionnaire 4-point Likert scale for assessment of epigastric pain epigastric burning belching bloating postprandial fullness early satiation nausea and vomiting and a global dyspeptic symptom assessment
GERD Symptom questionnaire GERDSQ 20080416 GERD symptom score questionnaire
Irritable Bowel Syndrome Symptom questionnaire IBSSQ 20080428 IBS symptom score questionnaire
Satiety test and ghrelin profile
After an overnight fast the patients are instructed to ingest Ensure 106 kcalml 22 fat 64 carbohydrate and 14 protein at constant rate of 30mlmin and complete a Fullness Rating Scale FRS at 3-min intervals ie 0min 3min 6min The test will stop when a score of 4 which is equivalent to unbearable fullness is reached in FRS The volume calorie of Ensure that is ingested will be recorded and it serves as surrogate marker of satiety function Serial blood sample 2ml each will also be taken at 0 30 60 90 120min during test for assay of ghrelin and gastrin profile If the test is stopped before 120 minutes the remaining blood will still be taken according to schedule
Gastric emptying test with FANci2
Measurement of gastric emptying rate of solid meal will be accomplished using 13C-octanoic acid breath test within 7 days after satiety test After 12-hour fasting the patient is required to ingest a pan-fried egg with 2 pieces of bread that contains 100 ul of 13C-octanoic acid dissolved in egg yolk The exhaled gas will be collected at 15-minute intervals until 4 hours have passed The 13CO2 content of the exhaled gas will be measured by a breath test device FANci2 FAN GmbHGermany 13CO2 is released after the 13C-octanoic acid enriched meal is emptied into the stomach and digested in duodenum
Randomization of treatment
After baseline investigations patients will be randomly assigned to either Esomeprazole 20 mg daily or identical looking placebo for 8 weeks The random allocation sequence will be obtained from a computer-generated list of random numbers in blocks of 10 Concealed allocation is achieved by an independent staff who assigns treatments according to consecutive numbers in sealed envelopes Study medications are dispensed as sealed packages in consecutive numbers Medication adherence is measured by pill counts during interval visits
Follow-up assessment
The patients will report their individual dyspeptic symptoms on weekly basis using a self-administered symptom questionnaire At week 4 and week 8 they will need to give an additional rating on their overall symptom response using global symptom assessment The patients are required to give a dichotomous response of either yes or no to the question stating Do you have adequate relief of symptoms over the past 7 days Satiety test and blood sampling gastric emptying study will be repeated at the end of 8-week treatment
Functional dyspepsia is one of the commonest digestive disorders It is a functional gastrointestinal disorder which is characterized by chronic recurrent epigastric symptoms such as pain burning and a variety of postprandial symptoms with absence of demonstrable organic pathology identified on investigations It has been reported that functional dyspepsia affects 10-30 of adult population
The pathophysiology of functional dyspepsia is uncertain It is thought to be a heterogeneous disorder Various factors have been implicated in the pathophysiology of functional dyspepsia It has been reported that delayed gastric emptying impaired proximal gastric accommodation visceral hypersensitivity and Helicobacter pylori gastritis play a role in development of functional dyspepsia However the correlation between these physiological abnormalities and symptomatology of functional dyspepsia is poor It is still controversial whether these pathophysiological factors are responsible for specific symptoms in functional dyspepsia
While mechanism of functional dyspepsia is unclear treatment has also been far from satisfactory Proton pump inhibitor has been recommended as the first line treatment for functional dyspepsia and it has been shown that the use of PPI is associated with a 14 reduction in risk of persistent dyspepsia compared to placebo However the mechanism of symptom relief is unclear While PPI exerts its effect primarily through suppression of acid-induced symptoms recent studies have shown that PPI may affect gastric motility function such as gastric volume gastric emptying and trigger of migratory motor complex Most of these studies were performed on healthy volunteers who received only a very short course of PPI The correlation between symptom and gastric emptying is lacking in these studies
Aims
To evaluate the effect of esomeprazole on gastric emptying
To evaluate the relationship between dyspeptic symptom and gastric emptying
Hypothesis
Long-term PPI relieves dyspeptic symptom through acceleration of gastric emptying rate
Study design
Double-blind randomized placebo-controlled trial
Baseline assessment
Demographic age gender
Anthropometric measurements body mass index height weight and waist circumference
FGI Screening Questionnaire v2 20090106 for screening of functional gastrointestinal disorder according to Rome III criteria
Functional dyspepsia symptom questionnaire FDSQ 20080416 an 8-item dyspeptic symptom score questionnaire 4-point Likert scale for assessment of epigastric pain epigastric burning belching bloating postprandial fullness early satiation nausea and vomiting and a global dyspeptic symptom assessment
GERD Symptom questionnaire GERDSQ 20080416 GERD symptom score questionnaire
Irritable Bowel Syndrome Symptom questionnaire IBSSQ 20080428 IBS symptom score questionnaire
Satiety test and ghrelin profile
After an overnight fast the patients are instructed to ingest Ensure 106 kcalml 22 fat 64 carbohydrate and 14 protein at constant rate of 30mlmin and complete a Fullness Rating Scale FRS at 3-min intervals ie 0min 3min 6min The test will stop when a score of 4 which is equivalent to unbearable fullness is reached in FRS The volume calorie of Ensure that is ingested will be recorded and it serves as surrogate marker of satiety function Serial blood sample 2ml each will also be taken at 0 30 60 90 120min during test for assay of ghrelin and gastrin profile If the test is stopped before 120 minutes the remaining blood will still be taken according to schedule
Gastric emptying test with FANci2
Measurement of gastric emptying rate of solid meal will be accomplished using 13C-octanoic acid breath test within 7 days after satiety test After 12-hour fasting the patient is required to ingest a pan-fried egg with 2 pieces of bread that contains 100 ul of 13C-octanoic acid dissolved in egg yolk The exhaled gas will be collected at 15-minute intervals until 4 hours have passed The 13CO2 content of the exhaled gas will be measured by a breath test device FANci2 FAN GmbHGermany 13CO2 is released after the 13C-octanoic acid enriched meal is emptied into the stomach and digested in duodenum
Randomization of treatment
After baseline investigations patients will be randomly assigned to either Esomeprazole 20 mg daily or identical looking placebo for 8 weeks The random allocation sequence will be obtained from a computer-generated list of random numbers in blocks of 10 Concealed allocation is achieved by an independent staff who assigns treatments according to consecutive numbers in sealed envelopes Study medications are dispensed as sealed packages in consecutive numbers Medication adherence is measured by pill counts during interval visits
Follow-up assessment
The patients will report their individual dyspeptic symptoms on weekly basis using a self-administered symptom questionnaire At week 4 and week 8 they will need to give an additional rating on their overall symptom response using global symptom assessment The patients are required to give a dichotomous response of either yes or no to the question stating Do you have adequate relief of symptoms over the past 7 days Satiety test and blood sampling gastric emptying study will be repeated at the end of 8-week treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None