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

NCT04306731 | Completed DMC

• 1 other identifier: College of Medicine
• Study Type: interventional
• Target: 437
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Recurrent Urinary Tract Infection

Keywords

nanotechnology water, antibiotic prophylaxis, recurrent UTI.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time to first recurrent UTI

  Twelve months

Study Arms (3)

Interventional (Group M)

EXPERIMENTAL

The group of patients given nanotechnology structured water magnalife

Dietary Supplement: Nanotechnology Structured water Magnalife

Control (Group T)

ACTIVE COMPARATOR

The group of patients given Trimethoprim

Drug: Trimethoprim

Placebo (Group O)

PLACEBO COMPARATOR

The group of patients given ordinary bottled drinking water

Dietary Supplement: Ordinary bottled drinking water

Interventions

Nanotechnology Structured water Magnalife DIETARY_SUPPLEMENT

Nanotechnology Structured water Magnalife is drinking water that has been modified using nanotechnology to change the structuring of water molecules

Also known as: Magnalife, 5200250040466

Interventional (Group M)

Trimethoprim DRUG

Antibiotic

Also known as: Proloprim

Control (Group T)

Ordinary bottled drinking water DIETARY_SUPPLEMENT

Placebo

Placebo (Group O)

Eligibility Criteria

• Age: 24 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sulaimani: lead

Study Sites (1)

College of Medicine, University of Sulaimani

Sulaymaniyah, Kurdistan Region, 00964, Iraq

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Trimethoprim

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ali K M.Sami, Ph.D.

  College of Medicine, University of Sulaimani

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: March 13, 2020
• Study Start: September 20, 2014
• Primary Completion: April 21, 2017
• Study Completion: April 21, 2017
• Last Updated: March 17, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)