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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04352062
Enrollment
152
Registered
2020-04-17
Start date
2011-01-09
Completion date
2018-10-26
Last updated
2020-04-17

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

Conditions

Melatonin Deficiency

Brief 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.

Detailed description

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.

Interventions

DRUGMelatonin
OTHERplacebo

pantoprazole 2 x 40mg

DRUGAmoxicillin

Amoxicillin 2 x 1000mg

Levofloxacin 2 x 500mg

Sponsors

Medical University of Lodz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
49 Years to 64 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
10 point Visual Analogue Scale (VAS) of Dyspeptic symptoms6 monthsscale 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)

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026