DyspepsiaDYSMOT-RIIINCT02113527
Gastric Activity and Gastrointestinal Peptides in Patients With Functional Dyspepsia
An observational study of Dyspepsia, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
Trial summary
Rome III criteria defined functional dyspepsia (FD) as the presence of symptoms from the gastroduodenal region in the absence of any organic, systemic or metabolic disease that is likely to explain the symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyspepsia
- How many people
- 75 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2014to Jun 2015
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be recruited in this observational study from the out-patients of the National Institute of Digestive Diseases, I.R.C.C.S. Saverio de Bellis, Castellana Grotte, Bari, Italy.
Who may be able to join
- Patients suffering from dyspeptic symptoms according to Rome III;
- Helicobacter pylori negative subjects;
- age 19-70 yr.;
- willingness to complete the study;
- not recent administration (in the 2 months before the examination) of anti-inflammatory drugs (NSAIDs), antibiotics, bismuth, antacids, H2-receptor antagonists, proton pump inhibitor, sucralfate or misoprostol;
- at least one endoscopic/radiological GI evaluation in the last 5 yrs.
Who cannot join
- previous history of gastric tumors or gastric surgery
- lactose intolerance;
- celiac disease, wheat sensitivity;
- alarm symptoms (GI bleeding, weight loose etc.);
- psychiatric diseases;
- familial history of peptic ulcer;
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- gastric cancer or IBD;
- abnormal thyroid function;
- other exclusion criteria (namely, pregnancy, breast-feeding, and drug allergies).
Trial locations and contacts
1 site in 1 country.
Italy1 site
National Institute of Digestive Diseases IRCCS "Saverio de Bellis"
Castellana Grotte, Bari, 70013
About this study
Official title: Evaluation of Gastric Emptying Time, Gastric Electrical Activity and Gastrointestinal Peptides to Identify Dyspeptic Patients With Epigastric Pain Syndrome From Those With Postprandial Distress Syndrome According to the Rome III Proposed Subdivision of Functional Dyspepsia
Rome III criteria defined functional dyspepsia (FD) as the presence of symptoms from the gastroduodenal region in the absence of any organic, systemic or metabolic disease that is likely to explain the symptoms. FD can be further subdivided into two diagnostic categories: postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS).
Disorders of gastric electric activity and abnormal gastric emptying are probably actively involved in the FD onset. Different noninvasive procedures may be applied in order to evaluate the gastric motor functions such as 13C breath testing and cutaneous electrogastrography. Besides, different gastrointestinal peptides (i.e. CCK, peptide YY, Neurotensin, Somatostatin, Leptin, Ghrelin, Motilin, Gastrin, Pepsinogen I and II) are involved in the control of gastroduodenal motility.
Aims of the present study are: 1) to evaluate the GI peptide circulating concentrations, the gastric electrical activity and gastric emptying time by applying noninvasive procedures in patients suffering from functional dyspepsia and 2) to test whether a significant difference exists between the two diagnostic categories of meal-induced dyspeptic symptoms
Read the detailed description
Functional dyspepsia is one of the most relevant functional gastrointestinal disorders (FGIDs) among general population. Rome III criteria defined functional dyspepsia as the presence of symptoms from the gastroduodenal region (early satiation, postprandial fullness, epigastric pain or burning) in the absence of any organic, systemic or metabolic disease that is likely to explain the symptoms. Etiological causes are still unclear, and the pathophysiological mechanisms still largely unknown. Besides, Helicobacter pylori infection is often present in these patients and contributes to complicate the clinical presentation. One of the main problem in the management of these patients is the lack of reliable biohumoral markers. Thus, functional disorders are usually diagnosed on the bases of symptomatic patterns. The Rome consensus has proposed to further subdivide FD into two diagnostic categories of meal-induced dyspeptic symptoms: postprandial distress syndrome (PDS), characterized by postprandial fullness and early satiation, and epigastric pain syndrome (EPS), characterized by epigastric pain and burning.
Central processing of visceral stimuli, and its role in the pathogenesis of functional dyspepsia, as well as low-grade inflammation in the duodenum are important emerging topics in pathophysiology research. In this framework, disorders of gastric electric activity and abnormal gastric emptying are probably actively involved in the onset of symptomatology. Different noninvasive procedures may be applied in order to evaluate the gastric motor functions. Among them, gastric emptying time evaluation by 13C breath testing and cutaneous electrogastrography have raised attention for their reliability and potentiality. Another important pathophysiological concern of FD is represented by the possible alterations in circulating concentrations of different gastrointestinal peptides at various degree involved in the control of gastroduodenal motility [namely Cholecystokinin (CCK), peptide YY, Neurotensin, Somatostatin, Leptin, Ghrelin, Motilin, Gastrin, Pepsinogen I and II]. In previous studies significant lower levels of motilin was found in dyspeptic patients with altered antroduodenal motility was found. CCK mediates satiety by acting on the CCK receptors distributed widely throughout the central nervous system as well as effects on the vagus nerve. Other experimental data suggest that somatostatin and neurotensin may affect muscle contractility and delay the intestinal transit.
On these bases aims of the study will be: 1) to evaluate the GI peptide circulating concentrations, the gastric electrical activity and gastric emptying time by applying noninvasive procedures in patients suffering from functional dyspepsia and 2) to test whether a significant difference exists between the two diagnostic categories of meal-induced dyspeptic symptoms
- Conditions
- Dyspepsia
- Keywords
- Electrogastrography, Functional dyspepsia, Gastric emptying, Gastrointestinal peptides, Rome III criteria
- 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 |
|---|---|---|
| Epigastric pain syndrome (EPS) | Patients suffering from functional dyspepsia characterized by epigastric pain syndrome according to Rome III criteria | |
| Postprandial distress syndrome (PDS) | Patients suffering from functional dyspepsia characterized by postprandial distress syndrome according to Rome III criteria | |
| Healthy subjects | Healthy subjects as control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting plasma concentration of GI peptides, gastric emptying time and dyspepsia subtype.
Exploration of relationships between GI peptide concentrations (CCK, peptide YY, Neurotensin, Somatostatin, Leptin, Ghrelin, Motilin, Gastrin, Pepsinogen I and II), solid gastric emptying, and dyspepsia subtype.
Blood samples will be compared pre/post test meal for FD cohorts (EPS/PDS) and controls: 0 time/baseline and 16 times/post meal.
Associations of plasma GI peptides pre and postprandial levels \& gastric emptying will be studied.
Amount of 13CO2 will be determined for each time point (1 pre/ 16 post meal) using equation nested in software package with IRMS.
The concentration of 13CO2 and 12CO2 in the exhaled breath samples will be measured by mass spectrometry.
Measured: Duration of 4-hour study visit
Secondary outcomes (1)
Gastric electrical activity and GI peptides according functional dyspepsia subtype
Correlations between plasma GI peptide concentrations and gastric electrical activity to be measured during gastric emptying time evaluation.
Gastric electrical activity will be measured by cutaneous electrogastrography.
Measured: Duration of 4-hour study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Russo, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Investigators
- Francesco Russo, MD, Principal investigator, IRCCS "S. de Bellis"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113527
- Sponsor's protocol ID
- RC192014
- Acronym
- DYSMOT-RIII
- Status last verified
- Sep 2015
- First submitted
- 26 Mar 2014
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Chasen M, Bhargava R. Gastrointestinal symptoms, electrogastrography, inflammatory markers, and PG-SGA in patients with advanced cancer. Support Care Cancer. 2012 Jun;20(6):1283-90. doi: 10.1007/s00520-011-1215-8. Epub 2011 Jun 19.
PubMed 21688162Miwa H, Watari J, Fukui H, Oshima T, Tomita T. [Pathogenesis and management of functional dyspepsia]. Nihon Rinsho. 2010 Jul;68(7):1391-401. Japanese.
PubMed 20662226Khoo J, Rayner CK, Feinle-Bisset C, Jones KL, Horowitz M. Gastrointestinal hormonal dysfunction in gastroparesis and functional dyspepsia. Neurogastroenterol Motil. 2010 Dec;22(12):1270-8. doi: 10.1111/j.1365-2982.2010.01609.x. Epub 2010 Oct 5.
PubMed 20939851De Smet B, Mitselos A, Depoortere I. Motilin and ghrelin as prokinetic drug targets. Pharmacol Ther. 2009 Aug;123(2):207-23. doi: 10.1016/j.pharmthera.2009.04.004. Epub 2009 May 6.
PubMed 19427331Geeraerts B, Mimidis K, van Oudenhove L, Vos R, Karamanolis G, Tack J. Role of endogenous opioids in the control of gastric sensorimotor function. Neurogastroenterol Motil. 2008 Oct;20(10):1094-102. doi: 10.1111/j.1365-2982.2008.01144.x. Epub 2008 May 15.
PubMed 18482249
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gastric Emptying Time, Gastric Electrical Activity and Gastrointestinal Peptides to Identify Dyspeptic Patients With Epigastric Pain Syndrome From Those With Postprandial Distress Syndrome According to the Rome III Proposed Subdivision of Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT02113527
- Acronym / sponsor ID
- DYSMOT-RIII / RC192014
- Conditions
- Dyspepsia
- Keywords
- Electrogastrography, Functional dyspepsia, Gastric emptying, Gastrointestinal peptides, Rome III criteria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 14 Apr 2014 (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.
Rome III criteria defined functional dyspepsia (FD) as the presence of symptoms from the gastroduodenal region in the absence of any organic, systemic or metabolic disease that is likely to explain the symptoms. FD can be further subdivided into two diagnostic categories: postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS).
Disorders of gastric electric activity and abnormal gastric emptying are probably actively involved in the FD onset. Different noninvasive procedures may be applied in order to evaluate the gastric motor functions such as 13C breath testing and cutaneous electrogastrography. Besides, different gastrointestinal peptides (i.e. CCK, peptide YY, Neurotensin, Somatostatin, Leptin, Ghrelin, Motilin, Gastrin, Pepsinogen I and II) are involved in the control of gastroduodenal motility.
Aims of the present study are: 1) to evaluate the GI peptide circulating concentrations, the gastric electrical activity and gastric emptying time by applying noninvasive procedures in patients suffering from functional dyspepsia and 2) to test whether a significant difference exists between the two diagnostic categories of meal-induced dyspeptic symptoms
Detailed description
Functional dyspepsia is one of the most relevant functional gastrointestinal disorders (FGIDs) among general population. Rome III criteria defined functional dyspepsia as the presence of symptoms from the gastroduodenal region (early satiation, postprandial fullness, epigastric pain or burning) in the absence of any organic, systemic or metabolic disease that is likely to explain the symptoms. Etiological causes are still unclear, and the pathophysiological mechanisms still largely unknown. Besides, Helicobacter pylori infection is often present in these patients and contributes to complicate the clinical presentation. One of the main problem in the management of these patients is the lack of reliable biohumoral markers. Thus, functional disorders are usually diagnosed on the bases of symptomatic patterns. The Rome consensus has proposed to further subdivide FD into two diagnostic categories of meal-induced dyspeptic symptoms: postprandial distress syndrome (PDS), characterized by postprandial fullness and early satiation, and epigastric pain syndrome (EPS), characterized by epigastric pain and burning.
Central processing of visceral stimuli, and its role in the pathogenesis of functional dyspepsia, as well as low-grade inflammation in the duodenum are important emerging topics in pathophysiology research. In this framework, disorders of gastric electric activity and abnormal gastric emptying are probably actively involved in the onset of symptomatology. Different noninvasive procedures may be applied in order to evaluate the gastric motor functions. Among them, gastric emptying time evaluation by 13C breath testing and cutaneous electrogastrography have raised attention for their reliability and potentiality. Another important pathophysiological concern of FD is represented by the possible alterations in circulating concentrations of different gastrointestinal peptides at various degree involved in the control of gastroduodenal motility [namely Cholecystokinin (CCK), peptide YY, Neurotensin, Somatostatin, Leptin, Ghrelin, Motilin, Gastrin, Pepsinogen I and II]. In previous studies significant lower levels of motilin was found in dyspeptic patients with altered antroduodenal motility was found. CCK mediates satiety by acting on the CCK receptors distributed widely throughout the central nervous system as well as effects on the vagus nerve. Other experimental data suggest that somatostatin and neurotensin may affect muscle contractility and delay the intestinal transit.
On these bases aims of the study will be: 1) to evaluate the GI peptide circulating concentrations, the gastric electrical activity and gastric emptying time by applying noninvasive procedures in patients suffering from functional dyspepsia and 2) to test whether a significant difference exists between the two diagnostic categories of meal-induced dyspeptic symptoms
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Epigastric pain syndrome (EPS) | – | –Patients suffering from functional dyspepsia characterized by epigastric pain syndrome according to Rome III criteria |
| Postprandial distress syndrome (PDS) | – | –Patients suffering from functional dyspepsia characterized by postprandial distress syndrome according to Rome III criteria |
| Healthy subjects | – | –Healthy subjects as control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited in this observational study from the out-patients of the National Institute of Digestive Diseases, I.R.C.C.S. Saverio de Bellis, Castellana Grotte, Bari, Italy.
Key inclusion criteria (6 listed)
- Patients suffering from dyspeptic symptoms according to Rome III;
- Helicobacter pylori negative subjects;
- age 19-70 yr.;
- willingness to complete the study;
- not recent administration (in the 2 months before the examination) of anti-inflammatory drugs (NSAIDs), antibiotics, bismuth, antacids, H2-receptor antagonists, proton pump inhibitor, sucralfate or misoprostol;
Key exclusion criteria (9 listed)
- previous history of gastric tumors or gastric surgery
- lactose intolerance;
- celiac disease, wheat sensitivity;
- alarm symptoms (GI bleeding, weight loose etc.);
- psychiatric diseases;
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
Fasting plasma concentration of GI peptides, gastric emptying time and dyspepsia subtype.
Time frame: Duration of 4-hour study visit
Exploration of relationships between GI peptide concentrations (CCK, peptide YY, Neurotensin, Somatostatin, Leptin, Ghrelin, Motilin, Gastrin, Pepsinogen I and II), solid gastric emptying, and dyspepsia subtype. Blood samples will be compared pre/post test meal for FD cohorts (EPS/PDS) and controls: 0 time/baseline and 16 times/post meal. Associations of plasma GI peptides pre and postprandial levels \& gastric emptying will be studied. Amount of 13CO2 will be determined for each time point (1 pre/ 16 post meal) using equation nested in software package with IRMS. The concentration of 13CO2 and 12CO2 in the exhaled breath samples will be measured by mass spectrometry.
1 secondary outcome
Gastric electrical activity and GI peptides according functional dyspepsia subtype
Time frame: Duration of 4-hour study 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 2 Sep 2015.
- Background: PubMed 21688162Chasen M, Bhargava R. Gastrointestinal symptoms, electrogastrography, inflammatory markers, and PG-SGA in patients with advanced cancer. Support Care Cancer. 2012 Jun;20(6):1283-90. doi: 10.1007/s00520-011-1215-8. Epub 2011 Jun 19.
- Background: PubMed 20662226Miwa H, Watari J, Fukui H, Oshima T, Tomita T. [Pathogenesis and management of functional dyspepsia]. Nihon Rinsho. 2010 Jul;68(7):1391-401. Japanese.
- Background: PubMed 20939851Khoo J, Rayner CK, Feinle-Bisset C, Jones KL, Horowitz M. Gastrointestinal hormonal dysfunction in gastroparesis and functional dyspepsia. Neurogastroenterol Motil. 2010 Dec;22(12):1270-8. doi: 10.1111/j.1365-2982.2010.01609.x. Epub 2010 Oct 5.
- Background: PubMed 19427331De Smet B, Mitselos A, Depoortere I. Motilin and ghrelin as prokinetic drug targets. Pharmacol Ther. 2009 Aug;123(2):207-23. doi: 10.1016/j.pharmthera.2009.04.004. Epub 2009 May 6.
- Background: PubMed 18482249Geeraerts B, Mimidis K, van Oudenhove L, Vos R, Karamanolis G, Tack J. Role of endogenous opioids in the control of gastric sensorimotor function. Neurogastroenterol Motil. 2008 Oct;20(10):1094-102. doi: 10.1111/j.1365-2982.2008.01144.x. Epub 2008 May 15.
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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.
Francesco Russo, MD principal investigator
IRCCS "S. de Bellis"
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 Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
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 6 inclusion and 9 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 2 Sep 2015. 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 Italy. 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?
Fasting plasma concentration of GI peptides, gastric emptying time and dyspepsia subtype. (time frame: Duration of 4-hour study visit). 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 NCT02113527, which also lists 5 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 2 Sep 2015.