Trial Outcomes & Findings for Use of Oral Probiotics to Reduce Urinary Oxalate Excretion (NCT NCT00587041)

Results Overview

Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate. Values for supersaturated ions are expressed in units of Gibbs free energy.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Time zero (on diet but no drug), 6 weeks (on drug and diet)

Results posted on

2012-05-31

Participant Flow

Subjects were recruited from Mayo Clinic, Rochester, Minnesota between Mayo 2006 and May 2009.

Participant milestones

Participant milestones
Measure	Agri-King Synbiotic Participants received AKSB for 6 weeks: AKSB 1 capsule twice daily plus 1 placebo packet daily. AKSB contains Fructo-oligosaccharide; Enterococcus faecium (SF68); Saccharomyces cerevisiae subspecies Boulardi; and Saccharomyces cerevisiae	Oxadrop Participants received Oxadrop for 6 weeks: Oxadrop 1 packet daily plus 1 placebo capsule twice daily. Each gram of Oxadrop® contains 2x1011 bacteria (L. acidophilus, L. brevis, S. thermophilus, and B. infantis)	Placebo Participants received placebo for 6 weeks: 1 placebo packet daily and 1 placebo capsule twice daily
Overall Study STARTED	12	14	14
Overall Study COMPLETED	12	14	14
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of Oral Probiotics to Reduce Urinary Oxalate Excretion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Agri-King Synbiotic n=12 Participants Participants received AKSB for 6 weeks: AKSB 1 capsule twice daily plus 1 placebo packet daily. AKSB contains Fructo-oligosaccharide; Enterococcus faecium (SF68); Saccharomyces cerevisiae subspecies Boulardi; and Saccharomyces cerevisiae	Oxadrop n=14 Participants Participants received Oxadrop for 6 weeks: Oxadrop 1 packet daily plus 1 placebo capsule twice daily. Each gram of Oxadrop® contains 2x1011 bacteria (L. acidophilus, L. brevis, S. thermophilus, and B. infantis)	Placebo n=14 Participants Participants received placebo for 6 weeks: 1 placebo packet daily and 1 placebo capsule twice daily	Total n=40 Participants Total of all reporting groups
Age Continuous	53.65 years STANDARD_DEVIATION 17.80 • n=5 Participants	54.22 years STANDARD_DEVIATION 14.12 • n=7 Participants	50.22 years STANDARD_DEVIATION 12.79 • n=5 Participants	52.79 years STANDARD_DEVIATION 14.64 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	14 Participants n=7 Participants	12 Participants n=5 Participants	36 Participants n=4 Participants
Region of Enrollment United States	12 participants n=5 Participants	14 participants n=7 Participants	14 participants n=5 Participants	40 participants n=4 Participants
Total Kidney Stones Passed	2.36 Number of Stones STANDARD_DEVIATION 2.2 • n=5 Participants	1.75 Number of Stones STANDARD_DEVIATION 0.93 • n=7 Participants	2.77 Number of Stones STANDARD_DEVIATION 2.35 • n=5 Participants	2.25 Number of Stones STANDARD_DEVIATION 1.86 • n=4 Participants

PRIMARY outcome

Timeframe: Time zero (on diet but no drug), 6 weeks (on drug and diet)

Population: As urine values for the final visit were not available for 5 subjects, they were not included in the analysis.

Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate. Values for supersaturated ions are expressed in units of Gibbs free energy.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received placebo for 6 weeks: 1 placebo packet daily and 1 placebo capsule twice daily	Oxadrop n=13 Participants Participants received Oxadrop for 6 weeks: Oxadrop 1 packet daily plus 1 placebo capsule twice daily. Each gram of Oxadrop® contains 2x1011 bacteria (L. acidophilus, L. brevis, S. thermophilus, and B. infantis)	Agri-King Synbiotic n=10 Participants Participants received AKSB for 6 weeks: AKSB 1 capsule twice daily plus 1 placebo packet daily. AKSB contains Fructo-oligosaccharide; Enterococcus faecium (SF68); Saccharomyces cerevisiae subspecies Boulardi; and Saccharomyces cerevisiae
Change in 24-hour Urinary Supersaturation for Calcium Oxalate	1.40 KJoules/mol Standard Deviation 0.65	1.36 KJoules/mol Standard Deviation 0.67	1.42 KJoules/mol Standard Deviation 0.49

SECONDARY outcome

Timeframe: At end of study, approximately 6 weeks

Population: As urine values for the final visit were not available for 5 subjects, they were not included in the analysis.

The amount of oxalate excreted in the urine over a 24 hour period, a risk for calcium oxalate kidney stones

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received placebo for 6 weeks: 1 placebo packet daily and 1 placebo capsule twice daily	Oxadrop n=13 Participants Participants received Oxadrop for 6 weeks: Oxadrop 1 packet daily plus 1 placebo capsule twice daily. Each gram of Oxadrop® contains 2x1011 bacteria (L. acidophilus, L. brevis, S. thermophilus, and B. infantis)	Agri-King Synbiotic n=10 Participants Participants received AKSB for 6 weeks: AKSB 1 capsule twice daily plus 1 placebo packet daily. AKSB contains Fructo-oligosaccharide; Enterococcus faecium (SF68); Saccharomyces cerevisiae subspecies Boulardi; and Saccharomyces cerevisiae
24 Hour Urine Oxalate Excretion	0.30 mmol/L Standard Deviation 0.10	0.31 mmol/L Standard Deviation 0.09	0.28 mmol/L Standard Deviation 0.07

Adverse Events

Agri-King Synbiotic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Oxadrop

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Use of Symbiotics to Reduce Urinary Oxalate Excretion

Mayo Clinic

Phone: 507-266-7960

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place