Trial Outcomes & Findings for Effectiveness of Cranberry Ingestion on Bacterial Adhesion: An Adjunct Study (NCT NCT00506025)

Last Updated: 2017-12-18

Results Overview

The primary outcome measure was the measurement of bacteriuria in study subject urine, defined as having a urine culture with 100,000 or more of a single uropathogen (measured as cfu per ml).

Recruitment status

COMPLETED

Study phase

Target enrollment

51 participants

Primary outcome timeframe

7 months, from enrollment at 3 months of pregnancy to delivery

Results posted on

2017-12-18

Participant Flow

Twenty-seven pregnant women who were enrolled were randomly selected for recruitment into this investigation.

Participant milestones

Participant milestones
Measure	Cranberry 2xday Cranberry (C) two times daily (C, C; n = 10 pregnant)	Cranberry + Placebo Cranberry in the a.m., then placebo (P) in the p.m. (C, P; n = 9 pregnant)	Placebo 2xday Placebo two times daily (P, P; n = 8 pregnant)
Overall Study STARTED	10	9	8
Overall Study COMPLETED	10	9	8
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness of Cranberry Ingestion on Bacterial Adhesion: An Adjunct Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cranberry 2xday n=10 Participants Cranberry (C) two times daily (C, C; n = 10 pregnant)	Cranberry + Placebo n=9 Participants Cranberry in the a.m., then placebo (P) in the p.m. (C, P; n = 9 pregnant)	Placebo 2xday n=8 Participants Placebo two times daily (P, P; n = 8 pregnant)	Total n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	27 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	29 years STANDARD_DEVIATION 5.26 • n=5 Participants	27 years STANDARD_DEVIATION 5.26 • n=7 Participants	24.5 years STANDARD_DEVIATION 5.26 • n=5 Participants	26.83 years STANDARD_DEVIATION 5.263 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	27 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	10 participants n=5 Participants	9 participants n=7 Participants	8 participants n=5 Participants	27 participants n=4 Participants

PRIMARY outcome

Timeframe: 7 months, from enrollment at 3 months of pregnancy to delivery

Population: a priori for a pilot study

The primary outcome measure was the measurement of bacteriuria in study subject urine, defined as having a urine culture with 100,000 or more of a single uropathogen (measured as cfu per ml).

Outcome measures

Outcome measures
Measure	Cranberry 2xday n=10 Participants Cranberry (C) two times daily (C, C; n = 10 pregnant)	Cranberry + Placebo n=9 Participants Cranberry in the a.m., then placebo (P) in the p.m. (C, P; n = 9 pregnant)	Placebo 2xday n=8 Participants Placebo two times daily (P, P; n = 8 pregnant)
Antimicrobial Activity of Urine From Pregnant Subjects Following Cranberry Juice Cocktail (CJC)	117.5 cfu per ml Interval 11.0 to 310.0	105.0 cfu per ml Interval 41.0 to 385.0	110.0 cfu per ml Interval 3.0 to 200.0

Adverse Events

Cranberry 2xday

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cranberry + Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo 2xday

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Deborah A. Wing, MD

University of California Irvine Medical Center

Phone: 714-456-5967

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place