Urinary Tract Infection ChronicPhase 4iHOMNCT05545514
Individualized Homeopathy to Reduce the Use of Antibiotics in Women With Recurrent Uncomplicated Urinary Tract Infections
A Phase 4 study testing One out of 140 predefined homeopathic medical products (HMP) in potency C200 or C1000, in people with Urinary Tract Infection Chronic, run by Technical University of Munich at 1 site in Germany.
Trial summary
The aim of the study is to determine the efficacy of individualised homeopathic drug treatment (potency C200 and C1000) compared to placebo in females (age 18<65) with recurrent urinary tract infections, per definition ≥ 2 UTI in 6 months and/ or ≥ 3 UTI in 9 months. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Urinary Tract Infection Chronic
- What is being tested?
- One out of 140 predefined homeopathic medical products (HMP) in potency C200 or C1000,
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteGermany
- Study dates
- 15 Mar 2023to 31 Jan 2026
- Phase
- Phase 4
- 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 18 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females, age 18 < 64 years
- Signed informed consent
- Documented recurrent UTI (i.e. ≥ 2 UTI in 6 months and/ or ≥ 3 UTI in 12 months)
- No change of other prophylactic treatment (e.g. Urovaxom, oestrogen) for recurrent UTI for at least three months before baseline
- No product or dosage change of systemic hormonal treatment (including oral anticonception) for at least three months before baseline
- Female participants who are not capable of bearing children or who use a method of contraception that is medically approved by the health authority of the respective country.
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- This includes:
- A woman who is not capable of bearing a child is defined as follows: post-menopausal (12 months natural (spontaneous) amenorrhea or 6 months spontaneous amenorrhea with serum-FSH-values (follicle-stimulating hormone) of >40 mIU/mL); 6 weeks after a bilateral ovariectomy with or without hysterectomy or sterilization by means of tubal ligation
- A woman capable of bearing child is defined as follows: a woman who is physiologically capable of becoming pregnant, including women whose occupation, lifestyle or sexual orientation exclude sexual intercourse with a male partner and women whose partners have been sterilized by vasectomy or other measures.
- Medically-approved methods of contraception can include the following: hormonal contraceptives, intrauterine device and double barrier method. Acceptable preventive measures can include total abstinence at the discretion of the investigator, in cases where compliance is ensured because of the study participant's age, occupation, lifestyle or sexual orientation. Periodical abstinence (e.g. calendar, ovulation, symptothermal methods or abstinence until the 4th day after the ovulation) as well as coitus interruptus are not acceptable methods of contraception.
- A reliable method of contraception must be used for the entire duration of the study.
Who cannot join
- 1. Individual symptomatology of the patient indicates the prescription of a HMP which is not available within this clinical trial 2. Pregnancy or breast feeding after pregnancy 3. Women with a complicated urinary tract infection (including infections occurring due to anatomical abnormalities (e.g. an obstruction, renal tract calculi, hydro nephrosis), infections occurring due to an immune compromised state (e.g. HIV, immune suppressive therapy), and recurrent infections despite adequate treatment (multi-drug resistant organisms or atypical organisms)) 4. Surgery of the urinary tract or the pelvic floor 5. Known hypersensivity against the study medication or the recommended on demand medication (Ibuprofen) 6. Homoeopathic therapy for recurrent UTIs during the last 6 months before baseline 7. Postmenopausal woman WITHOUT previous attempt of a therapy with locally applicate (vaginal) oestrogen 8. Serious acute or chronic organic disease or serious mental disorder, including
- diseases requiring immune suppressive therapy
- diabetes mellitus type 1 or 2 with an HbA1c > 7%
- any acute organic failure
- any advanced chronic organic failure (e.g. grade 3 or more)
- active cancer
- active (=clinically unstable) epileptic, cardiovascular or other organic pathology 9. Patients not able to declare meaningful informed consent on their own (e.g. with legal guardian), or other vulnerable patients (e.g. under arrest) 10. Simultaneous participation in any other clinical trial 11. Employees or family members of the sponsor or investigators
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum rechts der Isar, Department of Nephrology
München, Bavaria, 81675
About this study
The aim of the study is to determine the efficacy of individualised homeopathic drug treatment (potency C200 and C1000) compared to placebo in females (age 18<65) with recurrent urinary tract infections, per definition ≥ 2 UTI in 6 months and/ or ≥ 3 UTI in 9 months.
Read the detailed description
The World Health Organization has declared the problem of antibiotic resistance to be a global crisis and the European Union has defined, among other things, the reduction of antibiotic use in its strategies to avoid the development of resistance. Recurrent UTIs are one of the most common infectious diseases contributing to a multiple of multidrug- resistant extra intestinal pathogenic E coli, increasing morbidity and mortality due to many treatment failures and hospital admissions, which leads to increased healthcare costs. There is, therefore, an urgent need to optimize appropriate usage, in order to minimize the burden of disease for the patients and the health care services, while maintaining treatment safety at the same time.
In Germany, it is currently recommended to treat uncomplicated UTIs symptomatically as long as no dangerous course of the disease can be expected, but different treatment options aiming to decrease the frequency of UTI treated with antibiotics have shown only limited success. Thus, the symptom load of the affected patients as well as prescription rates for antibiotics remain high and treatment options are warranted by patients and physicians.
Homeopathy has shown relevant clinical effects for other recurrent infectious diseases and a reduction of the frequency of recurrent UTIs with individualised homeopathic treatment (iHOM) has been observed in practice. In this study we therefore aim to test the efficacy of this treatment approach as an add-on therapy to the treatment standard in a double-blind, placebo-controlled randomised clinical trial.
- Conditions
- Urinary Tract Infection Chronic
- Being tested
- One out of 140 predefined homeopathic medical products (HMP) in potency C200 or C1000,
- Keywords
- Cystitis, Nephritis
- Medical subject headings
- Cystitis, Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One out of 140 predefined homeopathic medical products (HMP) in potency C200 or C1000,Drug
Also called Placebo, Non-impregnated sucrose pillules, identical to the HMP (verum) in appearance, taste and size.
To investigate the efficacy of individualised homeopathic treatment (potency C200 and/or C1000) in comparison to placebo regarding the number of UTI treated with antibiotic agents.
| Study group | Role | What they receive |
|---|---|---|
| Verum | Experimental | Individualized homeopathy (iHOM):
One out of 140 predefined homeopathic medical products (HMP) in potency C200 or C1000, individually selected as indicated per homeopathic treatment principles. The HMPs are sucrose pillules, impregnated with the specific homeopathic substance and potency and will be administered once at baseline: 5 pillules sublingually. The dosage of the HMP can be repeated or adapted according to the homeopathic treatment principles three times during the course of the study and, in addition, in the event of an acute UTI. Receives: Drug: One out of 140 predefined homeopathic medical products (HMP) in potency C200 or C1000, |
| Placebo | Placebo comparator | Non-impregnated sucrose pillules, identical to the HMP (verum) in appearance, taste and size. Receives: Drug: One out of 140 predefined homeopathic medical products (HMP) in potency C200 or C1000, |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICIQ-FLUTS:
To compare the number of UTI treated with antibiotic agents, measured between Baseline and month 9 in both groups
A UTI is defined by the criteria of the German S3-guideline for the diagnostic of uncomplicated lower UTI:
- Clinical symptoms (either dysuria or increased urinary frequency or increased incontinence or pelvic pain) plus > 103 bacteria as monoculture in the urine culture, or
- Clinical symptoms plus urine test-strip with an evidence of nitrite and / or leukocyte-esterase and/ or blood
The criteria for a prescription of antibiotic agents to the patient are:
- Fever > 38.0 degree Celsius, and / or
- Persistent pain under symptomatic therapy with Ibuprofen, not tolerated by the patient, and / or
- Clinical suspicion of pyelonephritis
Measured: Baseline to month 9
Secondary outcomes (4)
ICIQ-FLUTS and ACSS
Time until the first UTI after the start of the study treatment (regardless of treatment of the first UTI)
Measured: Baseline to 6 month
ICIQ-FLUTS and ACSS
The number of UTI treated with antibiotic agents
Measured: measured between Baseline and month 9
ICIQ-FLUTS and ACCS
The number of UTI treated symptomatically
Measured: measured between Baseline and month 9
SF 12
Subjective symptom load and disease-specific quality of life over the last 3 months
Measured: measured at Baseline and month 9 per visual analogue scale (VAS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start15 Mar 2023
- Primary completion30 Jan 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract Infection ChronicStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase IV, monocentric, randomised, double-blind, parallel-group, placebo-controlled clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Klinikum rechts der Isar, TUM Institute for AI and Informatics in Medicine (AIIM)
- Responsible party
- Sponsor
- Investigators
- Lutz Renders, Prof. Dr. med., Principal investigator, Klinikum rechts der Isar, TUM, Department Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545514
- Sponsor's protocol ID
- IHO-0000-REN-0220-S
- Acronym
- iHOM
- Status last verified
- Apr 2024
- First submitted
- 14 Sep 2022
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Homeopathy to Reduce the Use of Antibiotics in Women With Recurrent Uncomplicated Urinary Tract Infections
- ClinicalTrials.gov ID
- NCT05545514
- Acronym / sponsor ID
- iHOM / IHO-0000-REN-0220-S
- Conditions
- Urinary Tract Infection Chronic
- Keywords
- Cystitis, Nephritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Klinikum rechts der Isar, TUM Institute for AI and Informatics in Medicine (AIIM)
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 19 Sep 2022 (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.
The aim of the study is to determine the efficacy of individualised homeopathic drug treatment (potency C200 and C1000) compared to placebo in females (age 18<65) with recurrent urinary tract infections, per definition ≥ 2 UTI in 6 months and/ or ≥ 3 UTI in 9 months.
Detailed description
The World Health Organization has declared the problem of antibiotic resistance to be a global crisis and the European Union has defined, among other things, the reduction of antibiotic use in its strategies to avoid the development of resistance. Recurrent UTIs are one of the most common infectious diseases contributing to a multiple of multidrug- resistant extra intestinal pathogenic E coli, increasing morbidity and mortality due to many treatment failures and hospital admissions, which leads to increased healthcare costs. There is, therefore, an urgent need to optimize appropriate usage, in order to minimize the burden of disease for the patients and the health care services, while maintaining treatment safety at the same time.
In Germany, it is currently recommended to treat uncomplicated UTIs symptomatically as long as no dangerous course of the disease can be expected, but different treatment options aiming to decrease the frequency of UTI treated with antibiotics have shown only limited success. Thus, the symptom load of the affected patients as well as prescription rates for antibiotics remain high and treatment options are warranted by patients and physicians.
Homeopathy has shown relevant clinical effects for other recurrent infectious diseases and a reduction of the frequency of recurrent UTIs with individualised homeopathic treatment (iHOM) has been observed in practice. In this study we therefore aim to test the efficacy of this treatment approach as an add-on therapy to the treatment standard in a double-blind, placebo-controlled randomised clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase IV, monocentric, randomised, double-blind, parallel-group, placebo-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Verum | Experimental | Drug: One out of 140 predefined homeopathic medical products (HMP) in potency C200 or C1000,Individualized homeopathy (iHOM): One out of 140 predefined homeopathic medical products (HMP) in potency C200 or C1000, individually selected as indicated per homeopathic treatment principles. The HMPs are sucrose pillules, impregnated with the specific homeopathic substance and potency and will be administered once at baseline: 5 pillules sublingually. The dosage of the HMP can be repeated or adapted according to the homeopathic treatment principles three times during the course of the study and, in addition, in the event of an acute UTI. |
| Placebo | Placebo comparator | Drug: One out of 140 predefined homeopathic medical products (HMP) in potency C200 or C1000,Non-impregnated sucrose pillules, identical to the HMP (verum) in appearance, taste and size. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Females, age 18 < 64 years
- Signed informed consent
- Documented recurrent UTI (i.e. ≥ 2 UTI in 6 months and/ or ≥ 3 UTI in 12 months)
- No change of other prophylactic treatment (e.g. Urovaxom, oestrogen) for recurrent UTI for at least three months before baseline
- No product or dosage change of systemic hormonal treatment (including oral anticonception) for at least three months before baseline
Key exclusion criteria (7 listed)
- 1. Individual symptomatology of the patient indicates the prescription of a HMP which is not available within this clinical trial 2. Pregnancy or breast feeding after pregnancy 3. Women with a complicated urinary tract infection (including infections occurring due to anatomical abnormalities (e.g. an obstruction, renal tract calculi, hydro nephrosis), infections occurring due to an immune compromised state (e.g. HIV, immune suppressive therapy), and recurrent infections despite adequate treatment (multi-drug resistant organisms or atypical organisms)) 4. Surgery of the urinary tract or the pelvic floor 5. Known hypersensivity against the study medication or the recommended on demand medication (Ibuprofen) 6. Homoeopathic therapy for recurrent UTIs during the last 6 months before baseline 7. Postmenopausal woman WITHOUT previous attempt of a therapy with locally applicate (vaginal) oestrogen 8. Serious acute or chronic organic disease or serious mental disorder, including
- diseases requiring immune suppressive therapy
- diabetes mellitus type 1 or 2 with an HbA1c > 7%
- any acute organic failure
- any advanced chronic organic failure (e.g. grade 3 or more)
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 |
|---|---|---|
| One out of 140 predefined homeopathic medical products (HMP) in potency C200 or C1000,Also: Placebo, Non-impregnated sucrose pillules, identical to the HMP (verum) in appearance, taste and size.To investigate the efficacy of individualised homeopathic treatment (potency C200 and/or C1000) in comparison to placebo regarding the number of UTI treated with antibiotic agents. | Drug | Placebo, Verum |
Primary outcome
ICIQ-FLUTS:
Time frame: Baseline to month 9
To compare the number of UTI treated with antibiotic agents, measured between Baseline and month 9 in both groups A UTI is defined by the criteria of the German S3-guideline for the diagnostic of uncomplicated lower UTI: 1. Clinical symptoms (either dysuria or increased urinary frequency or increased incontinence or pelvic pain) plus > 103 bacteria as monoculture in the urine culture, or 2. Clinical symptoms plus urine test-strip with an evidence of nitrite and / or leukocyte-esterase and/ or blood The criteria for a prescription of antibiotic agents to the patient are: 1. Fever > 38.0 degree Celsius, and / or 2. Persistent pain under symptomatic therapy with Ibuprofen, not tolerated by the patient, and / or 3. Clinical suspicion of pyelonephritis
4 secondary outcomes
ICIQ-FLUTS and ACSS
Time frame: Baseline to 6 month
ICIQ-FLUTS and ACSS
Time frame: measured between Baseline and month 9
ICIQ-FLUTS and ACCS
Time frame: measured between Baseline and month 9
SF 12
Time frame: measured at Baseline and month 9 per visual analogue scale (VAS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Lutz Renders, Prof. Dr. med. principal investigator
Klinikum rechts der Isar, TUM, Department Nephrology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing One out of 140 predefined homeopathic medical products (HMP) in potency C200 or C1000, in people with Urinary Tract Infection Chronic, run by Technical University of Munich at 1 site in Germany.
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 11 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 8 Nov 2024. 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 Germany. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
ICIQ-FLUTS: (time frame: Baseline to month 9). 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 8 Nov 2024.