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

Primary Purpose

Melatonin Deficiency

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Melatonin
placebo
Pantoprazole 40mg
Amoxicillin
Levofloxacin 500mg
Sponsored by
Medical University of Lodz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melatonin Deficiency

Eligibility Criteria

49 Years - 64 Years (Adult)FemaleAccepts 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

Sites / Locations

  • Department of Clinical Nutrition and Gastroenterological Diagnostics Medical University of Lodz

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Other

Arm Label

Treatment Group

Placebo

Helicobacter pylori infected group

Arm Description

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

1 tablet twice daily (period 6 months)

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
March 9, 2020
Last Updated
April 15, 2020
Sponsor
Medical University of Lodz
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1. Study Identification

Unique Protocol Identification Number
NCT04352062
Brief Title
Melatonin Supplementation in Postmenopausal Women With H. Pylori-associated Dyspepsia
Official Title
The Usefulness of Melatonin Supplementation in Postmenopausal Women With Helicobacter Pylori-associated Dyspepsia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 9, 2011 (Actual)
Primary Completion Date
October 26, 2018 (Actual)
Study Completion Date
October 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Lodz

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melatonin Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Melatonin ( 5-Methoxy-N-Acetyltryptamine) at dose 1mg/morning and 3mg/at bedtime (period 6 months)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 tablet twice daily (period 6 months)
Arm Title
Helicobacter pylori infected group
Arm Type
Other
Arm Description
Pantoprazole 2 x 40mg (twice daily) Amoxicyllin 2 x 1000mg (twice daily) Lovofloxacin 2 x 500mg (twice daily)
Intervention Type
Drug
Intervention Name(s)
Melatonin
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Type
Drug
Intervention Name(s)
Pantoprazole 40mg
Other Intervention Name(s)
Pantoprazole
Intervention Description
pantoprazole 2 x 40mg
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Other Intervention Name(s)
Amoxycillin
Intervention Description
Amoxicillin 2 x 1000mg
Intervention Type
Drug
Intervention Name(s)
Levofloxacin 500mg
Other Intervention Name(s)
Levofloxacin
Intervention Description
Levofloxacin 2 x 500mg
Primary Outcome Measure Information:
Title
10 point Visual Analogue Scale (VAS) of Dyspeptic symptoms
Description
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)
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
49 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cezary Chojnacki, MD.PhD.
Organizational Affiliation
Department of Clinical Nutrition and Gastroenterological Diagnostics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Nutrition and Gastroenterological Diagnostics Medical University of Lodz
City
Łódź
ZIP/Postal Code
90-647
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12914663
Citation
Heinemann LA, Potthoff P, Schneider HP. International versions of the Menopause Rating Scale (MRS). Health Qual Life Outcomes. 2003 Jul 30;1:28. doi: 10.1186/1477-7525-1-28.
Results Reference
background
PubMed Identifier
33243209
Citation
Chojnacki C, Medrek-Socha M, Konrad P, Chojnacki J, Blonska A. The value of melatonin supplementation in postmenopausal women with Helicobacter pylori-associated dyspepsia. BMC Womens Health. 2020 Nov 26;20(1):262. doi: 10.1186/s12905-020-01117-z.
Results Reference
derived

Learn more about this trial

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

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