Department of Clinical Nutrition and Gastroenterological Diagnostics Medical University of Lodz
Lodz, 90-647, Poland
NCT Number: NCT04352062
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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Notify Me49 year–64 year
Female
Interventional
Not applicable
Lodz, 90-647, Poland
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients with
Exclusion criteria
Patients with
pantoprazole 2 x 40mg
Other names: Pantoprazole
Amoxicillin 2 x 1000mg
Other names: Amoxycillin
Levofloxacin 2 x 500mg
Other names: Levofloxacin
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)
Medical University of Lodz
Other
The Usefulness of Melatonin Supplementation in Postmenopausal Women With Helicobacter Pylori-associated Dyspepsia
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