Cranberry Juice for Preventing UTIs

Overseen By Yavuz Yagiz, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Obesity, Pregnancy, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 21

Duration: 3 weeks

48 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators pre-preliminary study showed that the urine from a portion of study participants had anti-adhesion activity. The investigators propose that UTI susceptible women can be divided into responders and non-responders depending on whether cranberry intake increase anti-adhesion activity of their urine. The overall objectives are to identify gut microbes and anti-adhesive urinary biomarkers which significantly contribute to the anti-adhesion of E. coli.

Do I need to stop my current medications to join the trial?

Yes, you may need to stop taking medications that could influence the study's outcome.

Will I have to stop taking my current medications?

The trial excludes participants who take medications that might influence the study's outcome, so you may need to stop certain medications. It's best to discuss your current medications with the trial team to see if they are allowed.

What data supports the idea that Cranberry Juice for Preventing UTIs is an effective treatment?

The available research shows that cranberry juice and extracts can help prevent urinary tract infections (UTIs), especially in women with recurrent UTIs. One study found that cranberry extract with a high content of a specific compound (PAC-A) was effective in preventing UTIs. Another study showed that cranberry extract reduced the recurrence of UTIs in young people with a history of these infections. A meta-analysis, which combined results from 23 trials with nearly 4,000 participants, found that cranberry products significantly lowered the chance of getting UTIs in people who are more likely to have them. This suggests that cranberry juice can be a helpful treatment for preventing UTIs. ^{1 2 3 4 5}

What data supports the effectiveness of cranberry juice as a treatment for preventing UTIs?

Research shows that cranberry juice and extracts, which contain compounds called proanthocyanidins, can help prevent urinary tract infections (UTIs) by stopping bacteria from sticking to the urinary tract. Studies have found that cranberry products can significantly reduce the incidence of UTIs, especially in people who are prone to them. ^{1 2 3 4 5}

What safety data is available for cranberry juice in preventing UTIs?

Cranberry juice and extracts, particularly those containing A-type proanthocyanidins, are widely used for preventing urinary tract infections (UTIs). Clinical trials and studies have shown that cranberry products are generally safe, with no adverse events or side effects reported in trials involving both children and adults. The use of cranberry products also provides additional health benefits, such as antioxidant and cholesterol-lowering effects. However, the effectiveness and safety can vary due to differences in product composition and standardization. ^{1 2 4 6 7}

Is cranberry juice safe for preventing urinary tract infections?

Cranberry juice and extracts, including those with high proanthocyanidin content, are generally considered safe for human use, with no adverse effects reported in studies involving both children and adults. ^{1 2 4 6 7}

Is cranberry juice a promising treatment for preventing UTIs?

Yes, cranberry juice is a promising treatment for preventing UTIs. It contains special compounds called proanthocyanidins that stop bacteria from sticking to the urinary tract, which helps prevent infections. Studies have shown that cranberry juice can be effective, especially for women with recurring UTIs, and it also offers additional health benefits like antioxidant and cholesterol-lowering effects. ^{1 2 3 4 8}

How is cranberry juice different from other treatments for preventing UTIs?

Cranberry juice is unique because it contains proanthocyanidins (PACs) that prevent bacteria from sticking to the urinary tract, which is different from antibiotics that kill bacteria. This natural anti-adhesion mechanism is also being explored for other bacterial conditions, and cranberry products are generally safe with added benefits like antioxidant and cholesterol-lowering effects. ^{1 2 3 4 8}

Research Team

Liwei Gu, PhD

Principal Investigator

University of Florida

Yavuz Yagiz, PhD

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for healthy women who are prone to urinary tract infections (UTIs). Participants should weigh at least 110 pounds with a BMI between 18.5-29.9 kg/m2. Women who are pregnant, breastfeeding, have significant health issues, take medications that could affect the study's outcome, or have a BMI of 30 or higher cannot join.

Inclusion Criteria

Your body mass index (BMI) is within a healthy range.

I am a healthy woman.

I weigh at least 110 pounds.

Exclusion Criteria

Pregnancy and breast-feeding

You are a regular smoker or consume alcohol frequently.

History of any clinically important disorder that may interfere with interpretation of the results

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume cranberry or placebo juice for 21 days to assess changes in urinary anti-adhesion activity and gut microbiomes

3 weeks

Baseline and end of 21 days

Follow-up

Participants are monitored for changes in urinary biomarkers and gut microbiomes after treatment

4 weeks

Treatment Details

Interventions

• Cranberry Juice
• Placebo Juice

Trial Overview The study is testing if drinking cranberry juice can prevent UTIs in women likely to get them by increasing urine's anti-adhesion properties against E. coli bacteria. It will also identify gut microbes and biomarkers related to this effect.

Participant Groups

Group I: Placebo juice consumption Experimental Treatment 1 Intervention

Participants will be provided placebo juice to consume for 21 days

Group II: Experimental: Cranberry juice consumption Experimental Treatment 1 Intervention

Participants will be provided cranberry juice to consume for 21 days

Cranberry Juice is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cranberry Juice for:

• Urinary Tract Infection (UTI) prophylaxis

Approved in European Union as Cranberry Juice for:

• Urinary Tract Infection (UTI) prophylaxis

Approved in Canada as Cranberry Juice for:

• Urinary Tract Infection (UTI) prophylaxis

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Findings from Research

The study demonstrated that a cranberry extract called Oximacro, containing 36 mg of proanthocyanidins A (PAC-A), significantly reduced urinary tract infection (UTI) occurrences in both male and female volunteers after 7 days of administration.

Accurate measurement of PAC content is crucial for UTI prevention, as the study confirmed that Oximacro's high PAC-A content led to significant differences in UTI prevention compared to a placebo, highlighting its potential as an effective preventive treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of Urinary Tract Infection with Oximacro, A Cranberry Extract with a High Content of A-Type Proanthocyanidins: A Pre-Clinical Double-Blind Controlled Study. Occhipinti, A., Germano, A., Maffei, ME.[2020]

Cranberry (Vaccinium macrocarpon) has been shown to help prevent recurrent urinary tract infections (UTIs) in women by inhibiting the adhesion of E. coli bacteria to the bladder, thanks to specific compounds called proanthocyanidins (PAC).

Cranberry is a safe and well-tolerated supplement with no significant drug interactions, and while research is still in early stages, it may also offer additional health benefits such as anti-infective, anticancer, and antioxidant effects, as well as potential positive impacts on cardiovascular and metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccinium macrocarpon: an interesting option for women with recurrent urinary tract infections and other health benefits. Pérez-López, FR., Haya, J., Chedraui, P.[2009]

In a study involving 36 healthy adolescents aged 12 to 18 with recurrent urinary tract infections (UTIs), those who took a daily supplement of standardized cranberry extract (Anthocran®) experienced a significant reduction in UTIs, averaging 0.31 infections compared to 2.3 in the control group.

The cranberry extract also led to a higher percentage of symptom-free participants (63.1% in the supplementation group vs. 23.5% in the control group), demonstrating its potential as an effective prophylactic treatment for recurrent UTIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Highly standardized cranberry extract supplementation (Anthocran®) as prophylaxis in young healthy subjects with recurrent urinary tract infections. Ledda, A., Belcaro, G., Dugall, M., et al.[2018]

Cranberry juice has been shown to effectively prevent urinary tract infections (UTIs) in women with recurrent cases, primarily due to its anti-adhesive properties that stop bacteria from attaching to tissues.

The active compounds responsible for this effect are proanthocyanidins, and cranberry products are considered safe while also offering additional health benefits like antioxidant and cholesterol-lowering effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cranberry juice for prophylaxis of urinary tract infections--conclusions from clinical experience and research. Nowack, R., Schmitt, W.[2013]

Cranberry-based products significantly reduce the incidence of urinary tract infections (UTIs) in susceptible populations, with a risk ratio of 0.70, based on a meta-analysis of 23 trials involving 3979 participants.

Specific groups, such as women with recurrent UTIs, children, and patients using indwelling catheters, showed even greater reductions in UTI risk, highlighting cranberry's potential as an effective adjuvant therapy for prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumption of cranberry as adjuvant therapy for urinary tract infections in susceptible populations: A systematic review and meta-analysis with trial sequential analysis. Xia, JY., Yang, C., Xu, DF., et al.[2021]

A study of 19 commercial cranberry products revealed significant variability in their phenolic content and antiadhesion activity against uropathogenic bacteria, indicating that not all products are equally effective for preventing urinary tract infections (UTIs).

Only 4 out of the 19 products analyzed provided the recommended daily intake of 36 mg of proanthocyanidins, highlighting a lack of standardization in cranberry products and the potential for misleading health claims.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive assessment of the quality of commercial cranberry products. Phenolic characterization and in vitro bioactivity. Sánchez-Patán, F., Bartolomé, B., Martín-Alvarez, PJ., et al.[2012]

In a randomized controlled trial involving 55 uncircumcised boys, daily consumption of highly concentrated cranberry juice for 6 months significantly reduced the recurrence of urinary tract infections (UTIs) compared to a placebo, with only 25% of the cranberry juice group experiencing bacteriuria.

The study found that cranberry juice was more effective in preventing UTIs in uncircumcised boys than circumcision was in circumcised boys, with no reported adverse effects from the cranberry juice treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cranberries for Preventing Recurrent Urinary Tract Infections in Uncircumcised Boys. Wan, KS., Liu, CK., Lee, WK., et al.[2017]

A study involving healthy men and women showed that consuming three different cranberry extracts significantly enhanced the anti-adhesion activity of urine against harmful bacteria that cause urinary tract infections, specifically P-fimbriated Escherichia coli.

The cranberry extracts, each standardized to deliver 36 mg of proanthocyanidins (PACs), demonstrated this effect within 6 to 12 hours after intake, indicating a potential preventive measure for urinary tract health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the Anti-Adhesion Activity of Three Different Cranberry Extracts on Uropathogenic P-fimbriated Escherichia coli: a Randomized, Double-blind, Placebo Controlled, Ex Vivo, Acute Study. Howell, A., Souza, D., Roller, M., et al.[2022]

References

1. Iran pubmed.ncbi.nlm.nih.gov

Prevention of Urinary Tract Infection with Oximacro, A Cranberry Extract with a High Content of A-Type Proanthocyanidins: A Pre-Clinical Double-Blind Controlled Study. [2020]

2. Australia pubmed.ncbi.nlm.nih.gov

Vaccinium macrocarpon: an interesting option for women with recurrent urinary tract infections and other health benefits. [2009]

3. Italy pubmed.ncbi.nlm.nih.gov

Highly standardized cranberry extract supplementation (Anthocran®) as prophylaxis in young healthy subjects with recurrent urinary tract infections. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

Cranberry juice for prophylaxis of urinary tract infections--conclusions from clinical experience and research. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Consumption of cranberry as adjuvant therapy for urinary tract infections in susceptible populations: A systematic review and meta-analysis with trial sequential analysis. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Comprehensive assessment of the quality of commercial cranberry products. Phenolic characterization and in vitro bioactivity. [2012]

7. United States pubmed.ncbi.nlm.nih.gov

Cranberries for Preventing Recurrent Urinary Tract Infections in Uncircumcised Boys. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

Comparison of the Anti-Adhesion Activity of Three Different Cranberry Extracts on Uropathogenic P-fimbriated Escherichia coli: a Randomized, Double-blind, Placebo Controlled, Ex Vivo, Acute Study. [2022]