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
About this trial
This is an interventional treatment trial for Melatonin Deficiency
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
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
NCT ID
NCT04352062
First Posted
March 9, 2020
Last Updated
April 15, 2020
Sponsor
Medical University of Lodz
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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