Melatonin Supplementation in Postmenopausal Women With H. Pylori-associated Dyspepsia

• Status: Completed
• Trial end date: 2018-10-26
• Target enrollment: 0
• Participant gender: Female

Summary

Background: The aim of the study was to assess the role of melatonin in chronic dyspepsia in this group of women, with consideration of Helicobacter infection. Methods: The study comprised 152 subjects Including 30 healthy women (group I), 60 women with asymptomatic H.pylori infection (group II), and 64 women H. pylori infected with chronic dyspepsia(group III). Endoscopic examination, histological assessment of gastric end duodenal mucosa, urease breath test(UBT-13C), and serum levels of 17-β-estradiol, follicle stimulating hormone, melatonin and urinary concentration of 6-sulfatoxymelatonin were determined by immunoenzymatic method. In group III - 14-day antibacterial treatment was introduced with pantoprazole, amoxicillin and levofloxacin. Afterward, in 32 women was administered placebo(group IIIa), and in 32 women (group IIIb) melatonin at a dose 1 m/morning and 3 mg/at bedtime, for six months.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical University of Lodz; Medical Universtity of Lodz
• Treatments: Amoxicillin; Levofloxacin; Melatonin; Ofloxacin; Pantoprazole

Criteria

Inclusion Criteria:

Patients with

• Epigastric pain of a hunger nature

• Pain at night in the epigastric region

• Increased appetite

Exclusion Criteria:

Patients with

• Functional or inflammatory diseases of the gastrointestinal tract liver and pancreas

• Metabolic, allergic and mental disease

• Hormone replacement therapy