The association between acotiamide hydrochloride hydrate and bacteriostasis of H. pylori in H. pylori-positive patients with functional dyspepsia -open labeled study-

The association between acotiamide hydrochloride hydrate and bacteriostasis of H. pylori in H. pylori-positive patients with functional dyspepsia -open labeled study- - The association between acotiamide hydrochloride hydrate and bacteriostasis of H. pylori in H. pylori-positive patients with functional dyspepsia -open labeled study-

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000023886

Enrollment

Registered

2016-09-01

Start date

2016-09-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Functional dyspepsia Helicobacter pylori infection

Interventions

bacteriostatic of H. pylori by acotiamide hydrochloride hydrate

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) The patients that suffer from fullness after meal, fullness at epigastrium or early satiety for more than one month (2) In F scale, the score about Postprandial Distress Syndrome (PDS) is more than three points (The frequency of the symptom is more often). (3) the patients who examined esophagogastroduodenography in the past 6 months and have no organic disease in stomach. (4) Helicobacter pylori positive (5) Patients who are older than 20 years old and less than 80 years old. (6) Outpatients (7) Patients from whom written informed consent is obtained.

Exclusion criteria

Exclusion criteria: (1) Chief complain is heartburn or epigastric pain (2) The patients who have recieved the treatment of irritable bowel syndrome. (3) The patients who have taken proton pump inhibitor, antibacterial agent, antiprotozoal agent, bismuth preparation, or ecabet sodium in the past 2 weeks. (4) Severe drug allergy (5) The pregnant, the lactating woman, or the patient hoping pregnancy. (6) acotiamide allergy (7) Patients who are judged as being inappropriate for this study by their medical doctor

Design outcomes

Primary

Measure	Time frame
The change of urea breath test by taking acotiamide hydrochloride hydrate	—

Countries

Japan

Contacts

Public ContactKazuhiro Mizukami

Oita university Department of Gastroenterology

mizkaz0809@oita-u.ac.jp097-586-6193

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026