Probiotics as a Prophylactic Aid in Women With Recurrent Urinary Tract Infections (UTI's)

University Hospital, Akershus

Status: Unknown

Conditions: Urinary Tract Infections

Treatments: Dietary Supplement: Placebo Y cap G-3; Dietary Supplement: UREX-cap-5

Study type: Interventional

Funder types: Other

Identifiers

NCT00781625

S-08458d (REK)

08/7922(Shdir)

Details and patient eligibility

About

To investigate if administration of probiotics, either orally or vaginally,

• Can reduce the number of episodes of acute bacterial cystitis and/or
• Has tolerable adverse effect profile
• Improves general QoL in these women
• Improves the immune function and other physiological stress markers
• Reduces inflammation in urinary bladder epithelium

Full description

Chronic recurrent bacterial cystitis is a condition that is disabling to a great extent and which influences quality of life and freedom of movement. The episodes can be painful, and lead to extensive use of antibiotics, which in itself promotes development of bacterial strains increasingly resistant to antibiotics, but do not prevent relapses. Almost all cystitis' in women are ascending infections from bacteria in the vagina, following colonization from the rectum. There have, however, been reported indications that there may be bacteria colonies within the urothelium that might give rise to relapses of the infections, rather than pure reinfection from ascending pathogens.

Probiotics are cultures of viable microorganisms, which show a positive effect on the general condition of the host when administered. Among the lactic acid bacteria (LAB), lactobacilli are the most commonly used for probiotics, and they have an excellent safety record. In terms of UTI, weekly or twice weekly intravaginal instillation of Lactobacillus strains GR-1 and B-54 have led to reduced recurrences. This concept has been supported by a 2006 pilot study showing that intravaginal administration of Lactobacillus crispatus GAI 98322 every two days for one year, had the potential to reduce the UTI recurrences. Another approach has been taken whereby lactobacilli are administered orally with a view of simulating how the pathogens reach the vagina. The studies have shown that L. rhamnosus GR-1 and L. reuteri (formerly fermentum) RC-14 can reach the vagina after daily oral ingestion, and they can lower the bacterial and yeast pathogen numbers.

The aim of the study is to try to normalize the vaginal bacteriological milieu so that the more pathogenic subpopulation of bacteria strains are displaced and are less likely to cause UTI.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women 18-70 years old
• spontaneous urination
• > 3 UTI's previous year
• no ongoing prophylactic antibiotic treatment

Exclusion criteria

• > 50 ml residual urine
• neurological bladder disease
• known neoplasia, kidney stone or urinary tract abnormalities
• use og indwelling catheter
• pregnancy
• diabetes
• infrequent voiding pattern
• symptoms that indicate interstitial cystitis
• creatinin > 250 micmol/L
• participating in other clinical trial

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups, including a placebo group

Probiotic vaginal capsules

Active Comparator group

Description:

Probiotic vaginal capsule, placebo oral capsule

Treatment:

Dietary Supplement: UREX-cap-5

Dietary Supplement: UREX-cap-5

placebo

Placebo Comparator group

Description:

placebo oral capsule, placebo vaginal capsule

Treatment:

Dietary Supplement: Placebo Y cap G-3

Probiotic oral capsules

Active Comparator group

Description:

Probiotic oral capsules, placebo vaginal capsules

Treatment:

Dietary Supplement: UREX-cap-5

Dietary Supplement: UREX-cap-5