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

Sponsor
University of Sulaimani (Other)
Overall Status
Completed
CT.gov ID
NCT04306731
Collaborator
(none)
437
Enrollment
1
Location
3
Arms
31
Actual Duration (Months)
14.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Nanotechnology Structured water Magnalife
  • Drug: Trimethoprim
  • Dietary Supplement: Ordinary bottled drinking water
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
437 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
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.
Actual Study Start Date :
Sep 20, 2014
Actual Primary Completion Date :
Apr 21, 2017
Actual Study Completion Date :
Apr 21, 2017

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Recurrent Urinary Tract Infection [Twelve months]

      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)

    Secondary Outcome Measures

    1. Time to first recurrent UTI [Twelve months]

      The time since the beginning of the study until the first recurrent UTI (days)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    24 Years to 80 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 College of Medicine, University of Sulaimani Sulaymaniyah Kurdistan Region Iraq 00964

    Sponsors and Collaborators

    • University of Sulaimani

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ALI KAMAL M. SAMI, Principal investigator, University of Sulaimani
    ClinicalTrials.gov Identifier:
    NCT04306731
    Other Study ID Numbers:
    • College of Medicine
    First Posted:
    Mar 13, 2020
    Last Update Posted:
    Mar 17, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by ALI KAMAL M. SAMI, Principal investigator, University of Sulaimani
    nanotechnology water, antibiotic prophylaxis, recurrent UTI.
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Urinary Tract Infections
    Recurrence
    Trimethoprim

    Study Results

    No Results Posted as of Mar 17, 2020