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Completed

NCT Number: NCT04352062

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

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.

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Key information

Age range

49 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Nutrition and Gastroenterological Diagnostics Medical University of Lodz

Lodz, 90-647, Poland

About this study

Background:Dyspeptic syndrome in the form of epigastric pain are particularly frequent in postmenopausal women. 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Melatonin

Drug

Placebo

Other

Pantoprazole 40mg

Drug

pantoprazole 2 x 40mg

Other names: Pantoprazole

Amoxicillin

Drug

Amoxicillin 2 x 1000mg

Other names: Amoxycillin

Levofloxacin 500mg

Drug

Levofloxacin 2 x 500mg

Other names: Levofloxacin

Primary outcomes

  1. 10 point Visual Analogue Scale (VAS) of Dyspeptic symptoms

    Time frame: 6 months

    scale that access severity of Dyspeptic symptoms such as: epigastric pain of hunger nature and pain in the epigastric region at night (intensity measured from 1 to 10 points)

Sponsors and collaborators

Lead sponsor

Medical University of Lodz

Other

Registry information

Official study title

The Usefulness of Melatonin Supplementation in Postmenopausal Women With Helicobacter Pylori-associated Dyspepsia

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Apr 17, 2020
Registry last updated
Apr 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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