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

Primary Purpose

Urinary Tract Infection Chronic

Status
Recruiting
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
One out of 140 predefined homeopathic medical products (HMP) in potency C200 or C1000,
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Tract Infection Chronic focused on measuring Cystitis, Nephritis

Eligibility Criteria

18 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Females, age 18 < 65 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 recurrent UTI for at least three months before baseline
  5. No product or dosage change of systemic hormonal treatment (including oral anticonception) for at least three months before baseline
  6. 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.

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.

Exclusion Criteria:

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

Sites / Locations

  • Klinikum rechts der Isar, Department of NephrologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Verum

Placebo

Arm Description

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.

Non-impregnated sucrose pillules, identical to the HMP (verum) in appearance, taste and size.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

ICIQ-FLUTS and ACSS
Time until the first UTI after the start of the study treatment (regardless of treatment of the first UTI)
ICIQ-FLUTS and ACSS
The number of UTI treated with antibiotic agents
ICIQ-FLUTS and ACCS
The number of UTI treated symptomatically
SF 12
Subjective symptom load and disease-specific quality of life over the last 3 months

Full Information

First Posted
September 14, 2022
Last Updated
August 30, 2023
Sponsor
Technical University of Munich
Collaborators
School of Medicine, Technical University Munich, Münchner Studienzentrum, Klinikum rechts der Isar, TUM Institute for AI and Informatics in Medicine (AIIM)
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1. Study Identification

Unique Protocol Identification Number
NCT05545514
Brief Title
Individualized Homeopathy to Reduce the Use of Antibiotics in Women With Recurrent Uncomplicated Urinary Tract Infections
Acronym
iHOM
Official Title
Individualized Homeopathy to Reduce the Use of Antibiotics in Women With Recurrent Uncomplicated Urinary Tract Infections EudraCT:2021-002214-14
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich
Collaborators
School of Medicine, Technical University Munich, Münchner Studienzentrum, Klinikum rechts der Isar, TUM Institute for AI and Informatics in Medicine (AIIM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection Chronic
Keywords
Cystitis, Nephritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Phase IV, monocentric, randomised, double-blind, parallel-group, placebo-controlled clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double-blind
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Verum
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Non-impregnated sucrose pillules, identical to the HMP (verum) in appearance, taste and size.
Intervention Type
Drug
Intervention Name(s)
One out of 140 predefined homeopathic medical products (HMP) in potency C200 or C1000,
Other Intervention Name(s)
Placebo, Non-impregnated sucrose pillules, identical to the HMP (verum) in appearance, taste and size.
Intervention Description
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.
Primary Outcome Measure Information:
Title
ICIQ-FLUTS:
Description
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
Time Frame
Baseline to month 9
Secondary Outcome Measure Information:
Title
ICIQ-FLUTS and ACSS
Description
Time until the first UTI after the start of the study treatment (regardless of treatment of the first UTI)
Time Frame
Baseline to 6 month
Title
ICIQ-FLUTS and ACSS
Description
The number of UTI treated with antibiotic agents
Time Frame
measured between Baseline and month 9
Title
ICIQ-FLUTS and ACCS
Description
The number of UTI treated symptomatically
Time Frame
measured between Baseline and month 9
Title
SF 12
Description
Subjective symptom load and disease-specific quality of life over the last 3 months
Time Frame
measured at Baseline and month 9 per visual analogue scale (VAS)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lutz Renders, Prof. Dr. med.
Phone
+49894140
Ext
5049
Email
lutz.renders@tum.de
First Name & Middle Initial & Last Name or Official Title & Degree
Katharina Gaertner, Dr. med.
Phone
+41 78 948 05 76
Email
katharina.gaertner@uni-wh.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lutz Renders, Prof. Dr. med.
Organizational Affiliation
Klinikum rechts der Isar, TUM, Department Nephrology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum rechts der Isar, Department of Nephrology
City
München
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lutz Renders, Prof. Dr. med.
Phone
+49894140
Ext
2231
Email
lutz.redners@tum.de
First Name & Middle Initial & Last Name & Degree
Christioph Schmaderer, Prof. Dr. med.
Phone
+49894140
Ext
2231
Email
christioph.schmaderer@tum.de
First Name & Middle Initial & Last Name & Degree
Lutz Renders, Prof. Dr. med

12. IPD Sharing Statement

Plan to Share IPD
No

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

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