Symptoms and Physiological Effects of Amara in Functional Dyspepsia

• Status: Recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary aim of this investigator-initiated, prospective, open-label study is to assess perceived changes in symptom burden reported by in patients with functional dyspepsia treated with Amara. Additionally, the physiological effects of Amara on gastric motor and sensory function will be assessed using validated methods.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mark Fox

Criteria

Inclusion Criteria:

• Patients referred by their treating physician to the Center for integrative Gastroenterology at the Clinic Arlesheim

• Age over 18 years and ≦75 years of age

• Patients with Diagnosis of Functional Dyspepsia with Postprandial Distress (Rome IV criteria) with Leuven Dyspepsia Score "at least moderate" severity (>=10/20)

• Signed informed consent

• No change in medical treatment during the previous 1 month (e.g., proton pump inhibitor, antidepressants) during the last one month or for the duration of the period

• Good German knowledge (at least level B2 from Common European Framework of Reference for Languages)

Exclusion Criteria:

• Acute life-threatening conditions

• Withdrawal of informed consent

• Clinically relevant psychiatric comorbidity (HADS score >11)

• Advanced liver (Child score > 6) or kidney disease (GFR < 60)

• History of abdominal surgery except appendectomy

• Allergy to any component of Amara

• Pregnancy and lactation