Effect of Nanotechnology Structured Water Magnalife for the Prevention of Recurrent Urinary Tract Infections.

A Randomized, Double-blind, Placebo-controlled Clinical Study to Assess the Use of Nanotechnology Structured Water Magnalife for the Prevention of Recurrent Urinary Tract Infections.

This study investigates nanotechnology structured water magnalife in urology and to test its effects against lower urinary tract infections (UTI) in females.

Study Overview

• Status: Completed
• Conditions: Recurrent Urinary Tract Infection
• Intervention / Treatment: Dietary supplement: Nanotechnology Structured water Magnalife; Drug: Trimethoprim; Dietary supplement: Ordinary bottled drinking water

Detailed Description

This study represents the first time to use nanotechnology structured water magnalife in urology and to test its effects against lower urinary tract infections (UTI) in females. Urinary tract infection (UTI ) is the second most common bacterial infection, affecting women at a much higher frequency than men. There is a higher rate of recurrence of UTI, and a recurrent infection will follow 25-35% of initial UTI episodes within 3-6 months.

Intermittent or prolonged low dose antibiotic therapy has been used to treat and prevent recurrent UTI. Emerging of resistance to antimicrobial agents, enormous economic burden, and the side effects of antibiotics have led to the search for an alternative non-antibiotic prophylaxis of recurrent UTI. Nanotechnology structured water is a new type of drinking water that has been prepared using different types of energy fields and electromagnetic fields to produce this structured water, which has new and different characteristics from the ordinary water.

In the current study, the efficacy of nanotechnology structured water magnalife was compared with low-dose Trimethoprim and bottled drinking water for the prevention of recurrent UTI.

• Study Type: Interventional
• Enrollment (Actual): 437
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Kurdistan Region
    • Sulaymaniyah, Kurdistan Region, Iraq, 00964
      • College of Medicine, University of Sulaimani

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• ≥ 2 (two or more than two) UTI in the last 6 months
• ≥ 3 (three or more than three) UTI in the last 12 months

Exclusion Criteria:

• immunotherapy
• radiotherapy
• malignancy
• steroids
• chronic infections
• chemotherapy
• immunosuppressive drugs
• anatomical abnormality of the urinary tract
• surgical operation the urinary tract

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional (Group M); The group of patients given nanotechnology structured water magnalife	Dietary supplement: Nanotechnology Structured water Magnalife; Nanotechnology Structured water Magnalife is drinking water that has been modified using nanotechnology to change the structuring of water molecules; Other Names: Magnalife; 5200250040466
Active Comparator: Control (Group T); The group of patients given Trimethoprim	Drug: Trimethoprim; Antibiotic; Other Names: Proloprim
Placebo Comparator: Placebo (Group O); The group of patients given ordinary bottled drinking water	Dietary supplement: Ordinary bottled drinking water; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrent Urinary Tract Infection	Urinalysis by GUE (>10 white blood cells (WBC)/mm3 per high-power field (HPF) Urine culture (urinary pathogen of ≥105 colony-forming units (CFU) per mL)	Twelve months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first recurrent UTI	The time since the beginning of the study until the first recurrent UTI (days)	Twelve months

Collaborators and Investigators

• Sponsor: University of Sulaimani
• Investigators: Principal Investigator: Ali K M.Sami, Ph.D., College of Medicine, University of Sulaimani

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2014
• Primary Completion (Actual): April 21, 2017
• Study Completion (Actual): April 21, 2017

Study Registration Dates

• First Submitted: March 11, 2020
• First Submitted That Met QC Criteria: March 11, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 13, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: nanotechnology water, antibiotic prophylaxis, recurrent UTI.
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Infections; Communicable Diseases; Recurrence; Urinary Tract Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Folic Acid Antagonists; Anti-Dyskinesia Agents; Anti-Infective Agents, Urinary; Renal Agents; Cytochrome P-450 CYP2C8 Inhibitors; Trimethoprim
• Other Study ID Numbers: College of Medicine

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The duration of illness, number of recurrence of UTI, other co-morbid diseases

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No