Recurrent Urinary Tract InfectionNCT04306731
Effect of Nanotechnology Structured Water Magnalife for the Prevention of Recurrent Urinary Tract Infections.
A study testing Nanotechnology Structured water Magnalife, Trimethoprim and Ordinary bottled drinking water in people with Recurrent Urinary Tract Infection, run by University of Sulaimani at 1 site in Iraq.
Trial summary
This study investigates nanotechnology structured water magnalife in urology and to test its effects against lower urinary tract infections (UTI) in females. Read more about this study
- Who is it for?
- Ages 24 to 80 years, women only
- Conditions the study is for
- Recurrent Urinary Tract Infection
- What is being tested?
- Nanotechnology Structured water Magnalife, Trimethoprim and Ordinary bottled drinking water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 437 participants
- Where
- 1 siteIraq
- Study dates
- 20 Sep 2014to 21 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 2 (two or more than two) UTI in the last 6 months
- ≥ 3 (three or more than three) UTI in the last 12 months
Who cannot join
- immunotherapy
- radiotherapy
- malignancy
- steroids
- chronic infections
- chemotherapy
Show all 9Show fewer
- immunosuppressive drugs
- anatomical abnormality of the urinary tract
- surgical operation the urinary tract
Trial locations and contacts
1 site in 1 country.
Iraq1 site
College of Medicine, University of Sulaimani
Sulaymaniyah, Kurdistan Region, 00964
About this study
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.
This study investigates nanotechnology structured water magnalife in urology and to test its effects against lower urinary tract infections (UTI) in females.
Read the 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.
- Conditions
- Recurrent Urinary Tract Infection
- Being tested
- Nanotechnology Structured water Magnalife, Trimethoprim, Ordinary bottled drinking water
- Keywords
- nanotechnology water, antibiotic prophylaxis, recurrent UTI.
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanotechnology Structured water MagnalifeDietary supplement
Also called Magnalife, 5200250040466
Nanotechnology Structured water Magnalife is drinking water that has been modified using nanotechnology to change the structuring of water molecules
TrimethoprimDrug
Also called Proloprim
Antibiotic
Ordinary bottled drinking waterDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Interventional (Group M) | Experimental | The group of patients given nanotechnology structured water magnalife Receives: Dietary Supplement: Nanotechnology Structured water Magnalife |
| Control (Group T) | Active comparator | The group of patients given Trimethoprim Receives: Drug: Trimethoprim |
| Placebo (Group O) | Placebo comparator | The group of patients given ordinary bottled drinking water Receives: Dietary Supplement: Ordinary bottled drinking water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Twelve months
Secondary outcomes (1)
Time to first recurrent UTI
The time since the beginning of the study until the first recurrent UTI (days)
Measured: Twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start20 Sep 2014
- Primary completion21 Apr 2017
- Study completion21 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 437 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sulaimani
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ALI KAMAL M. SAMI, University of Sulaimani
- Investigators
- Ali K M.Sami, Ph.D., Principal investigator, College of Medicine, University of Sulaimani
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306731
- Sponsor's protocol ID
- College of Medicine
- Status last verified
- Mar 2020
- First submitted
- 11 Mar 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The duration of illness, number of recurrence of UTI, other co-morbid diseases
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04306731
- Acronym / sponsor ID
- College of Medicine
- Conditions
- Recurrent Urinary Tract Infection
- Keywords
- nanotechnology water, antibiotic prophylaxis, recurrent UTI.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 437 participants (actual)
- Lead sponsor
- University of SulaimaniUniversity, hospital or other
- Study start
- 20 Sep 2014 (actual)
- Primary completion
- 21 Apr 2017 (actual)
- Study completion
- 21 Apr 2017 (actual)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates nanotechnology structured water magnalife in urology and to test its effects against lower urinary tract infections (UTI) in females.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interventional (Group M) | Experimental | Dietary Supplement: Nanotechnology Structured water MagnalifeThe group of patients given nanotechnology structured water magnalife |
| Control (Group T) | Active comparator | Drug: TrimethoprimThe group of patients given Trimethoprim |
| Placebo (Group O) | Placebo comparator | Dietary Supplement: Ordinary bottled drinking waterThe group of patients given ordinary bottled drinking water |
Who may qualify
- Ages
- 24 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥ 2 (two or more than two) UTI in the last 6 months
- ≥ 3 (three or more than three) UTI in the last 12 months
Key exclusion criteria (9 listed)
- immunotherapy
- radiotherapy
- malignancy
- steroids
- chronic infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nanotechnology Structured water MagnalifeAlso: Magnalife, 5200250040466Nanotechnology Structured water Magnalife is drinking water that has been modified using nanotechnology to change the structuring of water molecules | Dietary supplement | Interventional (Group M) |
| TrimethoprimAlso: ProloprimAntibiotic | Drug | Control (Group T) |
| Ordinary bottled drinking waterPlacebo | Dietary supplement | Placebo (Group O) |
Primary outcome
Recurrent Urinary Tract Infection
Time frame: 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)
1 secondary outcome
Time to first recurrent UTI
Time frame: Twelve months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Individual participant dataSharing planned: No. The duration of illness, number of recurrence of UTI, other co-morbid diseases
Related trials for Recurrent Urinary Tract Infection
Active, not recruitingObservational study
Characterization of Vaginal, Urinary and Fecal Microbiomes in Women With Recurrent Urinary Tract Infections
Urinary Tract Infections, Menopause
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Probiotic Supplement for Recurrent UTIs in Healthy Women (L. Plantarum, L. Rhamnosus, B. Lactis)
Recurrent Urinary Tract Infections
RecruitingPhase 3
Evaluate the Efficacy and Safety of U101 Oral Capsules in the Prevention of Uncomplicated rUTIs in Women
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Active, not recruiting
Effect of a Probiotic on the Urinary Tract Microbiota of Participants With Recurrent Urinary Tract Infection.
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RecruitingPhase 4
Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants: a Pilot Study
Urinary Tract Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali K M.Sami, Ph.D. principal investigator
College of Medicine, University of Sulaimani
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nanotechnology Structured water Magnalife, Trimethoprim and Ordinary bottled drinking water in people with Recurrent Urinary Tract Infection, run by University of Sulaimani at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent Urinary Tract Infection (time frame: Twelve months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.