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

Melatonin Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04352062
• Other study ID #: BMWH-D-20-00081
• Status: Completed
• Phase: N/A
• Start date: January 9, 2011
• Est. completion date: October 26, 2018

Study information

• Verified date: March 2020
• Source: Medical Universtity of Lodz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: October 26, 2018
• Est. primary completion date: October 26, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 49 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyspepsia
• Melatonin Deficiency

Intervention

Drug:
• Melatonin

Other:
• placebo

Drug:
• Pantoprazole 40mg
pantoprazole 2 x 40mg
• Amoxicillin
Amoxicillin 2 x 1000mg
• Levofloxacin 500mg
Levofloxacin 2 x 500mg

Locations

Country	Name	City	State
Poland	Department of Clinical Nutrition and Gastroenterological Diagnostics Medical University of Lodz	Lódz

Sponsors (1)

Lead Sponsor	Collaborator
Medical Universtity of Lodz

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Heinemann LA, Potthoff P, Schneider HP. International versions of the Menopause Rating Scale (MRS). Health Qual Life Outcomes. 2003 Jul 30;1:28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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