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

NCT04352062 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2020-04-17

No results posted yet for this study

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.

Conditions

  • Melatonin Deficiency

Interventions

DRUG

Melatonin

OTHER

placebo

DRUG

Pantoprazole 40mg

pantoprazole 2 x 40mg

DRUG

Amoxicillin

Amoxicillin 2 x 1000mg

DRUG

Levofloxacin 500mg

Levofloxacin 2 x 500mg

Sponsors & Collaborators

  • Medical University of Lodz

    lead OTHER

Principal Investigators

  • Cezary Chojnacki, MD.PhD. · Department of Clinical Nutrition and Gastroenterological Diagnostics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
49 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-09
Primary Completion
2018-10-26
Completion
2018-10-26

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04352062 on ClinicalTrials.gov