Trial Outcomes & Findings for Nutraceutical Efficacy for rUTI (NCT NCT03395288)

Last Updated: 2022-02-04

Results Overview

To compare the cumulative incidence of symptomatic, culture-proven urinary tract infections in postmenopausal women with a history of rUTI on vaginal estrogen therapy randomized to receive prophylactic D-mannose versus women using vaginal estrogen therapy alone (control).

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

61 participants

Primary outcome timeframe

each participant will be followed for 90 days during study enrollment

Results posted on

2022-02-04

Participant Flow

Of the 61 patients consented, 4 patients were in the observational arm and 57 were in the RCT arm (28 treatment, 29 control).

Participant milestones

Participant milestones
Measure	RCT Treatment Arm Participants in this arm will dissolve one (1) level teaspoon of the nutraceutical powder (D-mannose) in at least 200 ml of water one time a day, approximately every 24 hours. (200 ml of water = 6.7 fluid ounces). Duration of study drug is 90 days. D-Mannose: A total of 2 g D-mannose daily	RCT Control Arm Participants in this arm will not use any additional intervention.	Observational Arm Participants in this arm will either take a total of 1000 mg D-mannose in capsule form every 12 hours OR they will dissolve one (1) level teaspoon of the nutraceutical powder (D-mannose) in at least 200 ml of water one time a day, approximately every 24 hours. (200 ml of water = 6.7 fluid ounces). Duration of study drug is 90 days. Participants in this arm of the study have different home medications prior to study enrollment than participants in the RCT treatment arm. D-Mannose: A total of 2 g D-mannose daily
Overall Study STARTED	28	29	4
Overall Study COMPLETED	19	25	3
Overall Study NOT COMPLETED	9	4	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nutraceutical Efficacy for rUTI

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RCT Treatment Arm n=28 Participants Participants in this arm will dissolve one (1) level teaspoon of the nutraceutical powder (D-mannose) in at least 200 ml of water one time a day, approximately every 24 hours. (200 ml of water = 6.7 fluid ounces). Duration of study drug is 90 days. D-Mannose: A total of 2 g D-mannose daily	RCT Control Arm n=29 Participants Participants in this arm will not use any additional intervention.	Observational Arm n=4 Participants Participants in this arm will either take a total of 1000 mg D-mannose in capsule form every 12 hours OR they will dissolve one (1) level teaspoon of the nutraceutical powder (D-mannose) in at least 200 ml of water one time a day, approximately every 24 hours. (200 ml of water = 6.7 fluid ounces). Duration of study drug is 90 days. Participants in this arm of the study have different home medications prior to study enrollment than participants in the RCT treatment arm. D-Mannose: A total of 2 g D-mannose daily	Total n=61 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	9 Participants n=5 Participants	13 Participants n=7 Participants	1 Participants n=5 Participants	23 Participants n=4 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants	16 Participants n=7 Participants	3 Participants n=5 Participants	38 Participants n=4 Participants
Age, Continuous	70.7 years n=5 Participants	67.4 years n=7 Participants	71.5 years n=5 Participants	69.2 years n=4 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	29 Participants n=7 Participants	4 Participants n=5 Participants	61 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
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants	28 Participants n=7 Participants	4 Participants n=5 Participants	60 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	28 Participants n=7 Participants	4 Participants n=5 Participants	58 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	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	28 participants n=5 Participants	29 participants n=7 Participants	4 participants n=5 Participants	61 participants n=4 Participants

PRIMARY outcome

Timeframe: each participant will be followed for 90 days during study enrollment

Population: 57 patients were enrolled in the RCT(28 randomized to the treatment arm , 29 to the control arm). 4 participants in the Observational Arm. A total of 44 patients started study day1 across all three groups. Data was analyzed for 19 patients in the treatment arm and 25 patients in the control arm. Due to early termination and low recruitment in the Observational Arm, data on the 4 participants was not analyzed (1 withdrew prior to study day 1, 1 withdrew prior to completion - not study related).

Outcome measures

Outcome measures
Measure	RCT Treatment Arm n=19 Participants Participants in this arm will dissolve one (1) level teaspoon of the nutraceutical powder (D-mannose) in at least 200 ml of water one time a day, approximately every 24 hours. (200 ml of water = 6.7 fluid ounces). Duration of study drug is 90 days. D-Mannose: A total of 2 g D-mannose daily	RCT Control Arm n=25 Participants Participants in this arm will not use any additional intervention.	Observational Arm n=2 Participants Participants in this arm will either take a total of 1000 mg D-mannose in capsule form every 12 hours OR they will dissolve one (1) level teaspoon of the nutraceutical powder (D-mannose) in at least 200 ml of water one time a day, approximately every 24 hours. (200 ml of water = 6.7 fluid ounces). Duration of study drug is 90 days. Participants in this arm of the study have different home medications prior to study enrollment than participants in the RCT treatment arm. D-Mannose: A total of 2 g D-mannose daily
Incidence of Symptomatic, Culture Proven Urinary Tract Infections	6 Participants	12 Participants	1 Participants

SECONDARY outcome

Timeframe: each participant will be followed for 90 days during study enrollment

Population: There were 57 patients enrolled in the RCT (28 randomized to the treatment arm and 29 randomized to the control arm). There were 4 participants in the observational arm (data for 2 available for informal analysis; 1 withdrew prior to study day 1; 1 withdrew week 3 not related to study drug0. A total of 44 patients started study day 1 across all three groups. Data was analyzed for 19 patients in the treatment arm and 25 patients in the control arm.

To compare the incidence of symptomatic, culture-proven urinary tract infections caused by all uropathogens potentially susceptible to D-mannose therapy in women receiving D-mannose and the control group. We will also compare these findings to the incidence of symptomatic, culture-proven urinary tract infections caused by uropathogens susceptible to D-mannose therapy in the absence of vaginal estrogen therapy (Control Arm).

Outcome measures

Outcome measures
Measure	RCT Treatment Arm n=19 Participants Participants in this arm will dissolve one (1) level teaspoon of the nutraceutical powder (D-mannose) in at least 200 ml of water one time a day, approximately every 24 hours. (200 ml of water = 6.7 fluid ounces). Duration of study drug is 90 days. D-Mannose: A total of 2 g D-mannose daily	RCT Control Arm n=25 Participants Participants in this arm will not use any additional intervention.	Observational Arm n=2 Participants Participants in this arm will either take a total of 1000 mg D-mannose in capsule form every 12 hours OR they will dissolve one (1) level teaspoon of the nutraceutical powder (D-mannose) in at least 200 ml of water one time a day, approximately every 24 hours. (200 ml of water = 6.7 fluid ounces). Duration of study drug is 90 days. Participants in this arm of the study have different home medications prior to study enrollment than participants in the RCT treatment arm. D-Mannose: A total of 2 g D-mannose daily
Incidence of Symptomatic Culture Proved UTI From D-mannose Susceptible Uropathogens	6 Participants	10 Participants	1 Participants

SECONDARY outcome

Timeframe: each participant will be followed for 90 days during study enrollment

Population: There were 57 patients enrolled in the RCT (28 randomized to the treatment arm and 29 randomized to the control arm). There were 4 participants in the observational arm. A total of 44 patients started study day 1 across all three groups. Data was analyzed for 19 patients in the treatment arm and 25 patients in the control arm.

To describe the side effects of D-mannose and determine the incidence of discontinuation of therapy due to side effects.

Outcome measures

Outcome measures
Measure	RCT Treatment Arm n=19 Participants Participants in this arm will dissolve one (1) level teaspoon of the nutraceutical powder (D-mannose) in at least 200 ml of water one time a day, approximately every 24 hours. (200 ml of water = 6.7 fluid ounces). Duration of study drug is 90 days. D-Mannose: A total of 2 g D-mannose daily	RCT Control Arm n=25 Participants Participants in this arm will not use any additional intervention.	Observational Arm n=2 Participants Participants in this arm will either take a total of 1000 mg D-mannose in capsule form every 12 hours OR they will dissolve one (1) level teaspoon of the nutraceutical powder (D-mannose) in at least 200 ml of water one time a day, approximately every 24 hours. (200 ml of water = 6.7 fluid ounces). Duration of study drug is 90 days. Participants in this arm of the study have different home medications prior to study enrollment than participants in the RCT treatment arm. D-Mannose: A total of 2 g D-mannose daily
Side Effects	3 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: each participant will be followed for 90 days during study enrollment

Population: There were 57 patients enrolled in the RCT (28 randomized to the treatment arm and 29 randomized to the control arm). There were 4 participants in the observational arm. A total of 44 patients started study day 1 across all three groups. Data was analyzed for 19 patients in the treatment arm and 25 patients in the control arm.

To compare the cumulative incidence of symptomatic, culture-proven urinary tract infections between women receiving prophylactic D-mannose treatment alongside vaginal estrogen therapy verses women receiving prophylactic D-mannose treatment whom are not on vaginal estrogen therapy (observational arm).

Outcome measures

Outcome measures
Measure	RCT Treatment Arm n=19 Participants Participants in this arm will dissolve one (1) level teaspoon of the nutraceutical powder (D-mannose) in at least 200 ml of water one time a day, approximately every 24 hours. (200 ml of water = 6.7 fluid ounces). Duration of study drug is 90 days. D-Mannose: A total of 2 g D-mannose daily	RCT Control Arm n=25 Participants Participants in this arm will not use any additional intervention.	Observational Arm n=2 Participants Participants in this arm will either take a total of 1000 mg D-mannose in capsule form every 12 hours OR they will dissolve one (1) level teaspoon of the nutraceutical powder (D-mannose) in at least 200 ml of water one time a day, approximately every 24 hours. (200 ml of water = 6.7 fluid ounces). Duration of study drug is 90 days. Participants in this arm of the study have different home medications prior to study enrollment than participants in the RCT treatment arm. D-Mannose: A total of 2 g D-mannose daily
Incidence of Symptomatic, Culture Proven UTI in All Participants Taking D-mannose	6 Participants	12 Participants	1 Participants

Adverse Events

RCT Treatment Arm

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

RCT Control Arm

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Observational Arm

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	RCT Treatment Arm n=27 participants at risk Participants in this arm will dissolve one (1) level teaspoon of the nutraceutical powder (D-mannose) in at least 200 ml of water one time a day, approximately every 24 hours. (200 ml of water = 6.7 fluid ounces). Duration of study drug is 90 days. D-Mannose: A total of 2 g D-mannose daily	RCT Control Arm n=29 participants at risk Participants in this arm will not use any additional intervention.	Observational Arm n=4 participants at risk Participants in this arm will either take a total of 1000 mg D-mannose in capsule form every 12 hours OR they will dissolve one (1) level teaspoon of the nutraceutical powder (D-mannose) in at least 200 ml of water one time a day, approximately every 24 hours. (200 ml of water = 6.7 fluid ounces). Duration of study drug is 90 days. Participants in this arm of the study have different home medications prior to study enrollment than participants in the RCT treatment arm. D-Mannose: A total of 2 g D-mannose daily
Gastrointestinal disorders Flatulence	40.7% 11/27 • Number of events 15 • Adverse events were collected from dose day 1 through 90 days after treatment.	17.2% 5/29 • Number of events 11 • Adverse events were collected from dose day 1 through 90 days after treatment.	50.0% 2/4 • Number of events 2 • Adverse events were collected from dose day 1 through 90 days after treatment.
Gastrointestinal disorders Diarrhea	14.8% 4/27 • Number of events 11 • Adverse events were collected from dose day 1 through 90 days after treatment.	20.7% 6/29 • Number of events 15 • Adverse events were collected from dose day 1 through 90 days after treatment.	0.00% 0/4 • Adverse events were collected from dose day 1 through 90 days after treatment.
Gastrointestinal disorders Dyspepsia	14.8% 4/27 • Number of events 6 • Adverse events were collected from dose day 1 through 90 days after treatment.	17.2% 5/29 • Number of events 9 • Adverse events were collected from dose day 1 through 90 days after treatment.	0.00% 0/4 • Adverse events were collected from dose day 1 through 90 days after treatment.

Additional Information

Jerry Lowder, MD

Washington University

Phone: 314-362-0063

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place