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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-09

Study Completion Date

2018-10-26

Brief Summary

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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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Detailed Description

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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.

Conditions

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Melatonin Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Treatment Group

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

Group Type EXPERIMENTAL

Melatonin

Intervention Type DRUG

Placebo

1 tablet twice daily (period 6 months)

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Helicobacter pylori infected group

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

Group Type OTHER

Pantoprazole 40mg

Intervention Type DRUG

pantoprazole 2 x 40mg

Amoxicillin

Intervention Type DRUG

Amoxicillin 2 x 1000mg

Levofloxacin 500mg

Intervention Type DRUG

Levofloxacin 2 x 500mg

Interventions

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Melatonin

Intervention Type DRUG

placebo

Intervention Type OTHER

Pantoprazole 40mg

pantoprazole 2 x 40mg

Intervention Type DRUG

Amoxicillin

Amoxicillin 2 x 1000mg

Intervention Type DRUG

Levofloxacin 500mg

Levofloxacin 2 x 500mg

Intervention Type DRUG

Other Intervention Names

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Pantoprazole Amoxycillin Levofloxacin

Eligibility Criteria

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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

Minimum Eligible Age

49 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes