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

NCT04352062 | Completed DMC

• 1 other identifier: BMWH-D-20-00081
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Melatonin Deficiency

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Treatment Group

EXPERIMENTAL

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

Drug: Melatonin

Placebo

PLACEBO COMPARATOR

1 tablet twice daily (period 6 months)

Other: placebo

Helicobacter pylori infected group

OTHER

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

Drug: Pantoprazole 40mg; Drug: Amoxicillin; Drug: Levofloxacin 500mg

Interventions

Melatonin DRUG

Treatment Group

placebo OTHER

Placebo

Pantoprazole 40mg DRUG

pantoprazole 2 x 40mg

Also known as: Pantoprazole

Helicobacter pylori infected group

Amoxicillin DRUG

Amoxicillin 2 x 1000mg

Also known as: Amoxycillin

Helicobacter pylori infected group

Levofloxacin 500mg DRUG

Levofloxacin 2 x 500mg

Also known as: Levofloxacin

Helicobacter pylori infected group

Eligibility Criteria

• Age: 49 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with
• Epigastric pain of a hunger nature
• Pain at night in the epigastric region
• Increased appetite

You may not qualify if:

• Patients with
• Functional or inflammatory diseases of the gastrointestinal tract liver and pancreas
• Metabolic, allergic and mental disease
• Hormone replacement therapy

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (1)

Department of Clinical Nutrition and Gastroenterological Diagnostics Medical University of Lodz

Lodz, 90-647, Poland

Location

Related Publications (2)

• 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.

  PMID: 12914663 BACKGROUND

• 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.

  PMID: 33243209 DERIVED

MeSH Terms

Interventions

Melatonin; Pantoprazole; Amoxicillin; Levofloxacin

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Study Officials

• Cezary Chojnacki, MD.PhD.

  Department of Clinical Nutrition and Gastroenterological Diagnostics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: April 17, 2020
• Study Start: January 9, 2011
• Primary Completion: October 26, 2018
• Study Completion: October 26, 2018
• Last Updated: April 17, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)