Gastric Activity and Gastrointestinal Peptides in Patients With Functional Dyspepsia

NCT02113527 | Completed

• 1 other identifier: RC192014
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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

Conditions

Dyspepsia

Keywords

Electrogastrography; Functional dyspepsia; Gastric emptying; Gastrointestinal peptides; Rome III criteria

Outcome Measures

Primary Outcomes (1)

• 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.

  Duration of 4-hour study visit

Secondary Outcomes (1)

• Gastric electrical activity and GI peptides according functional dyspepsia subtype

  Duration of 4-hour study visit

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis: lead

Study Sites (1)

National Institute of Digestive Diseases IRCCS "Saverio de Bellis"

Castellana Grotte, Bari, 70013, Italy

Location

Related Publications (5)

• 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.

  PMID: 21688162 BACKGROUND

• Miwa H, Watari J, Fukui H, Oshima T, Tomita T. [Pathogenesis and management of functional dyspepsia]. Nihon Rinsho. 2010 Jul;68(7):1391-401. Japanese.

  PMID: 20662226 BACKGROUND

• Khoo 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.

  PMID: 20939851 BACKGROUND

• De 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.

  PMID: 19427331 BACKGROUND

• Geeraerts 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.

  PMID: 18482249 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

breath specimen, whole blood, serum, white cells.

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Francesco Russo, MD

  IRCCS "S. de Bellis"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher

Study Record Dates

• First Submitted: March 26, 2014
• First Posted: April 14, 2014
• Study Start: April 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: June 1, 2015
• Last Updated: September 2, 2015

Record last verified: 2015-09

Locations

IT (1)