Individualized Homeopathy to Reduce the Use of Antibiotics in Women With Recurrent Uncomplicated Urinary Tract Infections

Last updated: November 7, 2024
Sponsor: Technical University of Munich
Overall Status: Active - Not Recruiting

Phase

4

Condition

Urinary Tract Infections

Treatment

One out of 140 predefined homeopathic medical products (HMP) in potency C200 or C1000,

Clinical Study ID

NCT05545514
IHO-0000-REN-0220-S
  • Ages 18-64
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Females, age 18 < 64 years

  2. Signed informed consent

  3. Documented recurrent UTI (i.e. ≥ 2 UTI in 6 months and/ or ≥ 3 UTI in 12 months)

  4. No change of other prophylactic treatment (e.g. Urovaxom, oestrogen) for recurrentUTI for at least three months before baseline

  5. No product or dosage change of systemic hormonal treatment (including oralanticonception) for at least three months before baseline

  6. Female participants who are not capable of bearing children or who use a method ofcontraception that is medically approved by the health authority of the respectivecountry.

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 withserum-FSH-values (follicle-stimulating hormone) of >40 mIU/mL); 6 weeks after abilateral ovariectomy with or without hysterectomy or sterilization by means oftubal ligation

  • A woman capable of bearing child is defined as follows: a woman who isphysiologically capable of becoming pregnant, including women whose occupation,lifestyle or sexual orientation exclude sexual intercourse with a male partner andwomen whose partners have been sterilized by vasectomy or other measures.

  • Medically-approved methods of contraception can include the following: hormonalcontraceptives, intrauterine device and double barrier method. Acceptable preventivemeasures can include total abstinence at the discretion of the investigator, incases 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 theovulation) as well as coitus interruptus are not acceptable methods ofcontraception.

  • A reliable method of contraception must be used for the entire duration of thestudy.

Exclusion

Exclusion Criteria:

  1. Individual symptomatology of the patient indicates the prescription of a HMP whichis not available within this clinical trial 2. Pregnancy or breast feeding afterpregnancy 3. Women with a complicated urinary tract infection (including infectionsoccurring 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 urinarytract or the pelvic floor 5. Known hypersensivity against the study medication orthe recommended on demand medication (Ibuprofen) 6. Homoeopathic therapy forrecurrent UTIs during the last 6 months before baseline 7. Postmenopausal womanWITHOUT 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

  1. Patients not able to declare meaningful informed consent on their own (e.g. withlegal guardian), or other vulnerable patients (e.g. under arrest) 10. Simultaneousparticipation in any other clinical trial 11. Employees or family members of thesponsor or investigators

Study Design

Total Participants: 220
Treatment Group(s): 1
Primary Treatment: One out of 140 predefined homeopathic medical products (HMP) in potency C200 or C1000,
Phase: 4
Study Start date:
March 15, 2023
Estimated Completion Date:
January 31, 2026

Study 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.

Connect with a study center

  • Klinikum rechts der Isar, Department of Nephrology

    München, Bayern 81675
    Germany

    Site Not Available

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