Symptom perception in patients with functional dyspepsia: involvement of the TRPV-1 neuropeptide pathway

Symptom perception in patients with functional dyspepsia: involvement of the TRPV-1 neuropeptide pathway - Functional dyspepsia and symptom perception

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55610

Enrollment

Registered

2015-04-22

Start date

2015-08-25

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional dyspepsia functional stomach complaints

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy controls

Exclusion criteria

Exclusion criteria: Healthy volunteers and functional dyspepsia patients: 1. Inability to stop the intake of NSAIDs within 14 days prior to endoscopy. 2. Inability to stop the intake of medication affecting gastrointestinal function (e.g. proton pump inhibitors, prokinetics, laxatives) within 5 days prior to endoscopy 3. Current use of antidepressants 4. Medical history of diabetes mellitus 5. Medical history of coeliac disease 6. Organic disease at upper gastrointestinal endoscopy (i.e. erosive esophagitis, Barrett*s esophagus, benign esophageal stricture, Schatzki ring, esophageal carcinoma, esophageal candidiasis, gastric ulcer, gastric erosions, gastric cancer, duodenal erosions or duodenal ulcer). 7. First-degree family members with diabetes mellitus type I, coeliac disease, Crohn*s disease or ulcerative colitis 8. Medical history of food allergy or anamnestic evidence of food allergy 9. Presence of coagulation disorders or use of anticoagulants 10. Dieting 11. Pregnancy or lactation 12. Smoking 13. Excessive alcohol use (>20 alcoholic consumptions/week) and inability to avoid use of alcohol in the 2 days prior to endoscopy

Design outcomes

Primary

Measure	Time frame
The primary objective of the present study is to assess the involvement of the duodenal TRPV-1 neuropeptide pathway in symptom perception in FD patients compared to healthy controls.	—

Secondary

Measure	Time frame
Symptoms: - To assess whether there are differences in gastrointestinal symptoms, psychological symptoms and quality of life between FD patients and healthy controls by using retrospective questionnaires. - To evaluate the number of FD patients with comorbid diagnosis of IBS. Gastric and duodenal tissue: - To assess the difference in transcription of genes encoding for proteins involved in intestinal barrier function (e.g. tight junction proteins) and symptom perception (e.g. TRPV-1), as well as protein expression of these proteins in both stomach and duodenum between FD patients and healthy controls. - To compare serotonin metabolism in mucosal tissue (e.g. 5-HT, 5-HIAA) between FD patients and healthy controls. Predominant symptoms - To assess whether there are differences in parameters involved in the TRPV-1 neuropeptide pathway (e.g. TRPV-1 mRNA transcription, neuropeptide concentrations) between (1) patients with predominant pain symptoms and (2) patients with predominant symptoms of epigastric fullness and bloating.	—

Measure

Time frame

Symptoms: - To assess whether there are differences in gastrointestinal symptoms, psychological symptoms and quality of life between FD patients and healthy controls by using retrospective questionnaires. - To evaluate the number of FD patients with comorbid diagnosis of IBS. Gastric and duodenal tissue: - To assess the difference in transcription of genes encoding for proteins involved in intestinal barrier function (e.g. tight junction proteins) and symptom perception (e.g. TRPV-1), as well as protein expression of these proteins in both stomach and duodenum between FD patients and healthy controls. - To compare serotonin metabolism in mucosal tissue (e.g. 5-HT, 5-HIAA) between FD patients and healthy controls. Predominant symptoms - To assess whether there are differences in parameters involved in the TRPV-1 neuropeptide pathway (e.g. TRPV-1 mRNA transcription, neuropeptide concentrations) between (1) patients with predominant pain symptoms and (2) patients with predominant symptoms of epigastric fullness and bloating.

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Countries

Netherlands

Outcome results