Condition category
Urological and Genital Diseases
Date applied
13/01/2017
Date assigned
30/01/2017
Last edited
31/01/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Urinary Tract Infections (UTIs) are a common infection of the bladder, kidneys and their connecting tubes. They are more common in women than in men. Cystitis is a common type of UTI that involves the inflammation (swelling) of the bladder. Some of the symptoms of UTIs and cystitis are pain while urinating, needing to urinate more often, pain in the stomach, and blood in the urine. They usually get better by themselves, but when they occur regularly (recurrent UTIs) they are treated by antibiotics (medication that kills bacteria). Due to growing concerns about bacteria becoming resistant to antibiotics, alternative treatments, such as herbal remedies are now looked at as a way to prevent UTIs in order to reduce antibiotic usage. This study looks to see if herbal remedies can prevent recurrent UTIs and cystitis.

Who can participate?
Women with recurrent UTIs and cystitis.

What does the study involve?
Participants are randomly allocated to one of three groups. Participants receive capsules to take orally (by mouth) for 90 days. Those in the first group take capsules containing D-Mannose (a naturally occurring simple sugar) in the morning and then a capsule in the evening containing a mix of herbal ingredients. Those in the second group take a D-Mannose capsule in the morning and then a capsule in the evening containing a different mix of herbal ingredients to the first group. Those in the last group take only one capsule in the evening that contains a mix of D-Mannose and other herbal ingredients. After the 90 days, participants are followed up through clinical examinations and interviews to assess if they had any reports of UTIs or cystitis.

What are the possible benefits and risks of participating?
Participants may benefit from a decrease in the amount of UTIs they have. There are no direct risks to those taking part in the study.

Where is the study run from?
Castiglione Prestianni Hospital (Italy)

When is the study starting and how long is it expected to run for?
March 2014 to December 2014

Who is funding the study?
Pharmamol SRL (Italy)

Who is the main contact?
Roberto Di Marco

Trial website

Contact information

Type

Scientific

Primary contact

Prof Roberto Di Marco

ORCID ID

http://orcid.org/0000-0001-5075-4597

Contact details

Department of Medicine and Healthy Sciences
University of Molise
Via Francesco De Sanctis
Cambopasso
86100
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GynUro05

Study information

Scientific title

Study on the effectiveness of an innovative combination of plant extracts (Berberine, Arbutin, Birch) that administered in conjunction with the D-mannose, for the prevention of recurrent urinary tract infections

Acronym

Study hypothesis

The aim of this study is to assess the potential preventive effects of a nutraceutical (herbal mixture) formulation in patients affected by acute uncomplicated cystitis and with a history of recurrent cystitis.

Ethics approval

Independent Ethical Committee for Non-Pharmacological Clinical Trials, 01/02/2014, ref: 2014/02

Study design

Single centre randomised parallel trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

No participant information sheet available

Condition

Cystitis

Intervention

All the patients meeting the inclusion criteria, who signed the informed consent form to participate in the clinical trial, are randomized to one of three arms ( A, B or C) to receive a three month prophylactic treatment.

Group A: Participants receive two capsules to ingest daily for 90 days consecutively. One capsule contains D-Mannose (78.8%) that is consumed in the morning and the other capsule contains Arbutin (61.9%), Birch (8.8%), and Berberin (5.4%), that is consumed in the evening.
Group B: Participants receive two capsules to ingest daily for 90 days consecutively. One capsule contains D-Mannose (78.8%) that is consumed in the morning and the other capsule contains Arbutin (62.8%), Birch (9%), Berberin (4.9%), and Forskolin (4.9%) that is consumed in the evening.
Group C: Participants receive capsules to ingest containing proanthocyanidins type A extracted from Cranberry (36 mg) and D-Mannose. This capsule is ingested once a day in the evening consecutively for 90 days.

After 90 days, participants are followed up until day 180 with a clinical evaluation if they have reported cases of cystitis. Participants who have not reported any cystitis are followed up by a phone interview.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

Symptomatic cystitis recurrence is measured through clinical evaluation and patient interviews at baseline, 90, 150/180 days.

Secondary outcome measures

Number of uropathogens is assessed using microbiological evaluation of urine sample, vaginal swab and a vaginal smear slide at baseline, 90 and 180 days.

Overall trial start date

27/09/2012

Overall trial end date

15/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women with a history of recurrent cystitis, defined as:
1.1. Participants must have two or more episodes of UTI in the last 6 months or 3-6 in the last 12 months
1.2. Participants much have had an UTI that was documented by urine culture
2. Experienced episodes at least by one urinary symptom and/or positive urinary nitrate test or leukocyturia

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

70

Participant exclusion criteria

1. Unable to provide informed consent
2. Pregnancy or lactation
3. Abnormalities of the upper urinary tract, including the presence of urinary stones
4. Patients with a permanent urinary catheter
5. Complete urinary incontinence
6. Patients with stage 5 chronic kidney disease (GFR <15 ml/min)

Recruitment start date

31/03/2014

Recruitment end date

13/06/2014

Locations

Countries of recruitment

Italy

Trial participating centre

Castiglione Prestianni Hospital
C.so Umberto, 406
Bronte
95100
Italy

Trial participating centre

Biomedical and Biotechnological Sciences Department
University of Catania Piazza Università, 2
Catania
95100
Italy

Trial participating centre

Department of Medicine and Healthy Sciences
Clinical Microbiology Laboratory University of Molise Via Francesco De Sanctis
Campobasso
86100

Sponsor information

Organisation

PharmaMol SRL

Sponsor details

Department of Medicine and Healthy Sciences
University of Molise
Via Francesco De Sanctis
Cambopasso
86100
Italy
+39 0874 404688
direzione.scientifica@pharmamol.com

Sponsor type

Industry

Website

http://www.pharmamol.com/index.htm

Funders

Funder type

Not defined

Funder name

Pharmamol SRL

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

A manuscript summarizing the results of the study it is currently in preparation. The manuscript will be submitted to an high-impact peer-reviewed journal.

IPD sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

31/12/2017

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes