DYSMOT-RIII: Gastric Activity and Gastrointestinal Peptides in Patients With Functional Dyspepsia

Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis (Other)

Overall Status

Completed

CT.gov ID

NCT02113527

Collaborator

(none)

Enrollment

Location

Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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

Condition or Disease	Intervention/Treatment	Phase
Dyspepsia

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

Study Type:

Observational

Actual Enrollment :

75 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

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

Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Fasting plasma concentration of GI peptides, gastric emptying time and dyspepsia subtype. [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.

Secondary Outcome Measures

Gastric electrical activity and GI peptides according functional dyspepsia subtype [Duration of 4-hour study visit]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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;
gastric cancer or IBD;
abnormal thyroid function;
other exclusion criteria (namely, pregnancy, breast-feeding, and drug allergies).