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

April 15, 2020 updated by: Medical University of Lodz

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Łódź, Poland, 90-647
        • Department of Clinical Nutrition and Gastroenterological Diagnostics Medical University of Lodz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

47 years to 62 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Lodz

Investigators

  • Principal Investigator: Cezary Chojnacki, MD.PhD., Department of Clinical Nutrition and Gastroenterological Diagnostics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2011

Primary Completion (Actual)

October 26, 2018

Study Completion (Actual)

October 26, 2018

Study Registration Dates

First Submitted

March 9, 2020

First Submitted That Met QC Criteria

April 15, 2020

First Posted (Actual)

April 17, 2020

Study Record Updates

Last Update Posted (Actual)

April 17, 2020

Last Update Submitted That Met QC Criteria

April 15, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMWH-D-20-00081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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