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

Study Overview
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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.

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.

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

Conditions
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Melatonin Deficiency

Intervention / Treatment
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* Drug: Melatonin
* Other: placebo
* Drug: Pantoprazole 40mg
* Drug: Amoxicillin
* Drug: Levofloxacin 500mg


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 49 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Melatonin ( 5-Methoxy-N-Acetyltryptamine) at dose 1mg/morning and 3mg/at bedtime (period 6 months) | Drug: Melatonin<br> <br> |
| Placebo Comparator: Placebo<br>1 tablet twice daily (period 6 months) | Other: placebo<br> <br> |
| Other: Helicobacter pylori infected group<br>Pantoprazole 2 x 40mg (twice daily) Amoxicyllin 2 x 1000mg (twice daily) Lovofloxacin 2 x 500mg (twice daily) | Drug: Pantoprazole 40mg<br>* pantoprazole 2 x 40mg<br>* Other names: Pantoprazole;Drug: Amoxicillin<br>* Amoxicillin 2 x 1000mg<br>* Other names: Amoxycillin;Drug: Levofloxacin 500mg<br>* Levofloxacin 2 x 500mg<br>* Other names: Levofloxacin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10 point Visual Analogue Scale (VAS) of Dyspeptic symptoms | 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) | 6 months |