Trial Outcomes & Findings for Cranberry for UTI Prevention in Residents of Long Term Care Facilities (NCT NCT00596635)

Results Overview

Urine cultures were collected at baseline and monthly for six months. The total number of urine cultures collected out of the total number that were expected to be collected are shown.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

56 participants

Primary outcome timeframe

6 months

Results posted on

2013-03-29

Participant Flow

Four dementia units participated in this study. Exclusion criteria included: 1)indwelling catheter, 2)residence \<4 weeks, 3)prednisone therapy, 4)active UTI symptoms, 5)terminal, 6)end stage renal disease, 7)\<60 years old, 8)chronic suppressive antibiotic therapy, 9)history of kidney stones, 10)unable to provide baseline urine, 11)warfarin therapy.

If a participant could not provide a baseline urine specimen or met an exclusion criterion prior to group assignment but after consent, he or she was not enrolled.

Participant milestones

Participant milestones
Measure	No Cranberry Capsules Control Group No Cranberry Capsule	One Cranberry Capsule 1 650mg cranberry capsule daily	2 Cranberry Capsules 1 650 mg cranberry capsule twice daily (bid)
Overall Study STARTED	17	20	19
Overall Study COMPLETED	10	7	11
Overall Study NOT COMPLETED	7	13	8

Reasons for withdrawal

Reasons for withdrawal
Measure	No Cranberry Capsules Control Group No Cranberry Capsule	One Cranberry Capsule 1 650mg cranberry capsule daily	2 Cranberry Capsules 1 650 mg cranberry capsule twice daily (bid)
Overall Study Lost to Follow-up	0	2	0
Overall Study Treatment for symptomatic UTI	4	6	3
Overall Study Hip fracture	2	3	3
Overall Study Could not provide urine specimen	1	2	2

Baseline Characteristics

Cranberry for UTI Prevention in Residents of Long Term Care Facilities

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Cranberry Capsules n=17 Participants Control Group No Cranberry Capsule	One Cranberry Capsule n=20 Participants 1 650mg cranberry capsule daily	2 Cranberry Capsules n=19 Participants 1 650 mg cranberry capsule twice daily (bid)	Total n=56 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	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants	20 Participants n=7 Participants	19 Participants n=5 Participants	55 Participants n=4 Participants
Age Continuous	85.76 years STANDARD_DEVIATION 11.76 • n=5 Participants	88.30 years STANDARD_DEVIATION 6.16 • n=7 Participants	86.68 years STANDARD_DEVIATION 5.16 • n=5 Participants	86.82 years STANDARD_DEVIATION 7.97 • n=4 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	17 Participants n=7 Participants	16 Participants n=5 Participants	46 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Region of Enrollment United States	17 participants n=5 Participants	20 participants n=7 Participants	19 participants n=5 Participants	56 participants n=4 Participants

PRIMARY outcome

Timeframe: 6 months

Urine cultures were collected at baseline and monthly for six months. The total number of urine cultures collected out of the total number that were expected to be collected are shown.

Outcome measures

Outcome measures
Measure	No Cranberry Capsules n=17 Participants Control Group No Cranberry Capsule	One Cranberry Capsule n=20 Participants 1 650mg cranberry capsule daily	2 Cranberry Capsules n=19 Participants 1 650 mg cranberry capsule twice daily (bid)
Number of Urine Cultures Collected Out of the Total Number Expected to be Collected. Number of urine cultures expected	81 Urine cultures	74 Urine cultures	85 Urine cultures
Number of Urine Cultures Collected Out of the Total Number Expected to be Collected. Number of urine cultures collected	73 Urine cultures	63 Urine cultures	71 Urine cultures

SECONDARY outcome

Timeframe: 6 months

Urine cultures were obtained at baseline and monthly for six months. Any participant that had E.coli isolated at least once is listed as meeting the outcome.

Outcome measures

Outcome measures
Measure	No Cranberry Capsules n=17 Participants Control Group No Cranberry Capsule	One Cranberry Capsule n=20 Participants 1 650mg cranberry capsule daily	2 Cranberry Capsules n=19 Participants 1 650 mg cranberry capsule twice daily (bid)
Number of Participants With E.Coli Isolated From Urine Culture	8 Participants	8 Participants	12 Participants

SECONDARY outcome

Timeframe: 6 months

Urine cultures were obtained at baseline and monthly for 6 months. If a urine culture had \>100,000 colony forming units per milliliter of any organism on any of the urine cultures obtained, the participant is noted as meeting the outcome.

Outcome measures

Outcome measures
Measure	No Cranberry Capsules n=17 Participants Control Group No Cranberry Capsule	One Cranberry Capsule n=20 Participants 1 650mg cranberry capsule daily	2 Cranberry Capsules n=19 Participants 1 650 mg cranberry capsule twice daily (bid)
Number of Participants With >100,000 Colony Forming Units Per Milliliter of Any Organism Isolated From Urine Culture	12 Participants	13 Participants	14 Participants

Adverse Events

No Cranberry Capsules

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

One Cranberry Capsule

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

2 Cranberry Capsules

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	No Cranberry Capsules n=17 participants at risk Control Group No Cranberry Capsule	One Cranberry Capsule n=20 participants at risk 1 650mg cranberry capsule daily	2 Cranberry Capsules n=19 participants at risk 1 650 mg cranberry capsule twice daily (bid)
Gastrointestinal disorders Vomiting	0.00% 0/17 • 6 months	15.0% 3/20 • Number of events 3 • 6 months	10.5% 2/19 • Number of events 2 • 6 months
Gastrointestinal disorders Nausea	5.9% 1/17 • Number of events 1 • 6 months	5.0% 1/20 • Number of events 1 • 6 months	5.3% 1/19 • Number of events 1 • 6 months
Gastrointestinal disorders Diarrhea	5.9% 1/17 • Number of events 1 • 6 months	5.0% 1/20 • Number of events 1 • 6 months	0.00% 0/19 • 6 months
Gastrointestinal disorders Gastroenteritis	5.9% 1/17 • Number of events 1 • 6 months	0.00% 0/20 • 6 months	0.00% 0/19 • 6 months

Additional Information

Manisha Juthani-Mehta, MD

Yale University School of Medicine

Phone: (203)785-4140

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place