PEA in Functional Dyspepsia

Inclusion Criteria:

• Patients with functional dyspepsia as diagnosed by the Rome IV criteria.

• Subjects must provide witnessed written informed consent prior to any studyprocedures being performed.

• Subjects aged 18-70 years old.

• Male or female subjects.

• Subjects who are capable to understand the study and the questionnaires, and tocomply with the study requirements.

• Women of child-bearing potential agree to apply a highly effective method of birthcontrol during the entire duration of the trial. Highly effective birth control isdefined as those which result in a low failure rate (i.e., less than 1% per year)when used constantly and correctly such as implants, injectables, combined oralcontraceptive method, or some intrauterine devices (IUDs), sexual abstinence, orvasectomized partner. Women of non-childbearing potential may be included ifsurgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses.

Exclusion Criteria:

• Presence of a history of gastrointestinal surgery other than appendectomy andcholecystectomy.

• Organic gastro-intestinal disease

• Major psychiatric disorder such as major depression

• Presence of coeliac disease, lupus, scleroderma and other systemic auto-immunedisease.

• Patients with eosinophilic esophagitis

• Presence of diabetes mellitus

• Active H. Pylori infection or < 6 months after eradication

• Predominant IBS (based on the Rome IV questionnaire)

• Predominant GERD (based on the Rome IV questionnaire)

• Patients taking prohibited medication

• Females who are pregnant or lactating

• Patients not capable to understand or be compliant with the study.