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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether cranberry juice can prevent urinary tract infections (UTIs) by stopping bacteria from adhering. Researchers have found that urine from some individuals who drank cranberry juice could prevent this bacterial adhesion. They aim to determine if women who frequently experience UTIs would benefit from drinking cranberry juice. Healthy women who weigh at least 110 pounds and do not smoke may qualify for this study. Participants will drink cranberry juice for a short period to assess its effectiveness. As an unphased trial, this study offers a unique opportunity to contribute to understanding how cranberry juice might benefit those prone to UTIs.

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.

Is there any evidence suggesting that cranberry juice is likely to be safe for humans?

Research has shown that cranberry juice is generally safe for most people. Studies have found that consuming cranberry products, such as juice, does not cause harmful effects. Some evidence suggests that cranberry juice might help reduce the number of urinary tract infections (UTIs) for some individuals over time. However, strong scientific proof that cranberry juice can treat or prevent UTIs is lacking. Overall, cranberry juice is well-tolerated, but consulting a doctor before starting any new treatment is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Cranberry juice is unique because it offers a natural alternative for preventing urinary tract infections (UTIs). Unlike antibiotics, which are the standard treatment and can lead to resistance over time, cranberry juice contains compounds like proanthocyanidins that prevent bacteria from sticking to the urinary tract walls. Researchers are excited about this treatment as it could provide a safer, non-antibiotic option that reduces the risk of resistance and offers an easily accessible and pleasant way to potentially prevent UTIs.

What evidence suggests that cranberry juice might be an effective treatment for UTIs?

Studies have shown that cranberry juice can help prevent urinary tract infections (UTIs). A large review found that cranberry products reduced the risk of UTIs by 30% to 54% compared to not using them. Another study found that cranberry products lowered the UTI risk by 21% in women. This trial will test cranberry juice consumption as a method to prevent UTIs. These findings suggest that cranberry juice might work by stopping bacteria from sticking to the urinary tract. Overall, cranberry juice has shown promise in reducing the risk of UTIs, especially for those who experience them frequently. ^{6 7 8 9 10}

Who Is on the Research Team?

Liwei Gu, PhD

Principal Investigator

University of Florida

Yavuz Yagiz, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Participants will be provided with cranberry juice to consume for 4 days after 10 10-day run-in period.

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+

Published Research Related to This Trial

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]

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]

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 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 (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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2405456924001226

Cranberry Juice, Cranberry Tablets, or Liquid Therapies for ... A total of 20 trials (3091 participants) were included, with 18 studies highlighting a 54% lower rate of UTIs with cranberry juice consumption than no treatment ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2210803322000719

Cranberry (Vaccinium macrocarpon) as a prophylaxis for ... The study concluded that cranberry products reduced the risk of UTI by 21 % in women compared with the placebo group (0.79 [CI 0.67, 0.94], I2 = 47 %, P = 0.008) ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29046404/

Cranberry Reduces the Risk of Urinary Tract Infection ... Results of the meta-analysis showed that cranberry reduced the risk of UTI by 26% (pooled risk ratio: 0.74; 95% CI: 0.55, 0.98; I2 = 54%). Risk of bias ...

4. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165(25)00022-X/fulltext

Whole cranberry fruit powder supplement reduces the ... This study shows that whole cranberry powder capsules do not impact safety markers and reduce the incidence of culture-confirmed UTI and several other UTI- ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37068952/

Cranberries for preventing urinary tract infections In moderate certainty evidence, cranberry products reduced the risk of UTIs (6211 participants: RR 0.70, 95% CI 0.58 to 0.84; I² = 69%). When ...

6. aafp.org aafp.org/pubs/afp/issues/2004/1201/p2175.html

Cranberry for Prevention of Urinary Tract Infections Systematic reviews have concluded that no reliable evidence supports the use of cranberry in the treatment or prophylaxis of urinary tract infections.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3370320/

Cranberries and lower urinary tract infection prevention They concluded that there is some evidence that cranberry juice may decrease the number of symptomatic UTIs over a 12 month period, particularly, and only, for ...

8. webmd.com webmd.com/vitamins/ai/ingredientmono-958/cranberry

Cranberry - Uses, Side Effects, and More Cranberry is also used for kidney stones, enlarged prostate, the common cold, and many other conditions, but there is no good scientific evidence to support ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S000291652500022X

Whole cranberry fruit powder supplement reduces the ... This study shows that whole cranberry powder capsules do not impact safety markers and reduce the incidence of culture-confirmed UTI and several other UTI- ...

10. fda.gov fda.gov/media/140304/download

Health Claim Petition - Consumption of Cranberry Products ... In an intention-to-treat analysis, data from all women enrolled in the study (n = 176) and both doses (4 oz and 8 oz) of cranberry juice ...