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

Medical University of Lodz

Status: Completed

Conditions: Melatonin Deficiency

Treatments: Other: placebo; Drug: Melatonin; Drug: Levofloxacin 500mg; Drug: Pantoprazole 40mg; Drug: Amoxicillin

Study type: Interventional

Funder types: Other

Identifiers

NCT04352062

BMWH-D-20-00081

Details and patient eligibility

About

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.

Full 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.

Enrollment: 152 patients

Sex: Female

Ages: 49 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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152 participants in 3 patient groups, including a placebo group

Treatment Group

Experimental group

Description:

Melatonin ( 5-Methoxy-N-Acetyltryptamine) at dose 1mg/morning and 3mg/at bedtime (period 6 months)

Treatment:

Drug: Melatonin

Placebo

Placebo Comparator group

Description:

1 tablet twice daily (period 6 months)

Treatment:

Other: placebo

Helicobacter pylori infected group

Other group

Description:

Pantoprazole 2 x 40mg (twice daily) Amoxicyllin 2 x 1000mg (twice daily) Lovofloxacin 2 x 500mg (twice daily)

Treatment:

Drug: Amoxicillin

Drug: Levofloxacin 500mg

Drug: Pantoprazole 40mg