Clinical trial NCT04352062: 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
Overall status: COMPLETED
Phase: NA
Conditions: Melatonin Deficiency
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 152
Sex: FEMALE
Minimum age (years): 49
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 10 point Visual Analogue Scale (VAS) of Dyspeptic symptoms
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Łódź
country: Poland
facility: Department of Clinical Nutrition and Gastroenterological Diagnostics Medical University of Lodz
Study officials:
affiliation: Department of Clinical Nutrition and Gastroenterological Diagnostics
name: Cezary Chojnacki, MD.PhD.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.