Trial Outcomes & Findings for Gut Microbiome and p-Inulin in Hemodialysis (NCT NCT02572882)

Results Overview

The weighted UniFrac distance was used to compute the distances for each sample. Weighted UniFrac distance uses species abundance information and weights the branch length with abundance difference. Weighted UniFrac distance is most sensitive to detect change in abundant lineages since it uses absolute abundance difference in its definition.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

13 participants

Primary outcome timeframe

28 weeks

Results posted on

2022-10-20

Participant Flow

The protocol allowed for enrollment of up to 20 individuals with the goal or having 10 participants complete the first 20 weeks of the study with satisfactory completeness of biosample collection.

Participant milestones

Participant milestones
Measure	Full Study Cohort This was a sequential study in which participants moved through 3 phases - 8 weeks during which no treatment was administed, 12 weeks during which p-inulin was self-administered orally, 8g twice daily, and another 8 weeks during which no treatment was administered.
Overall Study STARTED	13
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Full Study Cohort This was a sequential study in which participants moved through 3 phases - 8 weeks during which no treatment was administed, 12 weeks during which p-inulin was self-administered orally, 8g twice daily, and another 8 weeks during which no treatment was administered.
Overall Study Withdrawal by Subject	1
Overall Study Participant received kidney transplant	1

Baseline Characteristics

Gut Microbiome and p-Inulin in Hemodialysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=13 Participants This is a sequential study in which participants are observed (no intervention) for 8 weeks (pre-treatment), then participants self-administer p-inulin 8g orally twice daily for 12 weeks (treatment phase), and then observed for a final 8 weeks during which no treatment was administered (post-treatment).
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=99 Participants
Age, Categorical >=65 years	1 Participants n=99 Participants
Age, Continuous	48.2 years STANDARD_DEVIATION 12.5 • n=99 Participants
Sex: Female, Male Female	5 Participants n=99 Participants
Sex: Female, Male Male	8 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	11 Participants n=99 Participants
Race (NIH/OMB) White	2 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	13 participants n=99 Participants

PRIMARY outcome

Timeframe: 28 weeks

Population: Two participants withdrew at the beginning of the second phase of the trial. One participant with antibiotic use was not included in the microbiome composition analysis.

The weighted UniFrac distance was used to compute the distances for each sample. Weighted UniFrac distance uses species abundance information and weights the branch length with abundance difference. Weighted UniFrac distance is most sensitive to detect change in abundant lineages since it uses absolute abundance difference in its definition.

Outcome measures

Outcome measures
Measure	Full Study Cohort n=10 Participants This study includes three sequential phases: 1. Pre-treatment phase: 8 weeks during which no treatment was administered 2. p-Inulin phase: 12 weeks during which p-inulin was administered 8g orally twice daily 3. Post-treatment phase: 8 weeks during which no treatment was administered	Week 4 Week 4 Visit, pre-treatment phase	Week 8 Week 8 visit, pre-treatment phase	Week 12 Week 12 visit, treatment phase	Week 16 Week 16 visit, treatment phase	Week 20 Week 20 visit, treatment phase	Week 24 Week 24 visit, post-treatment phase	Week 28 Week 28 visit, post-treatment phase
Within Participant Variability in Microbiome Composition by Treatment Phase pre-treatment	0.165 weighted unifrac distrance Interval 0.111 to 0.208	—	—	—	—	—	—	—
Within Participant Variability in Microbiome Composition by Treatment Phase treatment	0.175 weighted unifrac distrance Interval 0.129 to 0.228	—	—	—	—	—	—	—
Within Participant Variability in Microbiome Composition by Treatment Phase post-treatment	0.210 weighted unifrac distrance Interval 0.129 to 0.266	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 28 weeks

Population: Two participants withdrew at the beginning of the second phase of the trial. One participant with antibiotic use was not included in the microbiome composition analysis.

The Euclidean distance was used to compute the distances for each sample. The Euclidean distance is defined as the distance between two points. Differences between samples were determined on the basis of distances from the initial measurements to account for participant-level differences in initial abundance of microorganisms.

Outcome measures

Outcome measures
Measure	Full Study Cohort n=10 Participants This study includes three sequential phases: 1. Pre-treatment phase: 8 weeks during which no treatment was administered 2. p-Inulin phase: 12 weeks during which p-inulin was administered 8g orally twice daily 3. Post-treatment phase: 8 weeks during which no treatment was administered	Week 4 Week 4 Visit, pre-treatment phase	Week 8 Week 8 visit, pre-treatment phase	Week 12 Week 12 visit, treatment phase	Week 16 Week 16 visit, treatment phase	Week 20 Week 20 visit, treatment phase	Week 24 Week 24 visit, post-treatment phase	Week 28 Week 28 visit, post-treatment phase
Within Participant Variability in Stool Metabolome by Treatment Phase pre-treatment	14.49 Euclidean distance Interval 11.93 to 18.15	—	—	—	—	—	—	—
Within Participant Variability in Stool Metabolome by Treatment Phase treatment	15.70 Euclidean distance Interval 13.37 to 18.32	—	—	—	—	—	—	—
Within Participant Variability in Stool Metabolome by Treatment Phase post-treatment	16.77 Euclidean distance Interval 12.92 to 18.12	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 28 weeks (8 weeks pre-treatment, 12 weeks of treatment, 8 weeks post-treatment)

Population: Two participants withdrew at the beginning of the second phase of the trial. One participant with antibiotic use was not included in the microbiome composition analysis.

The Euclidean distance was used to compute the distances for each sample. The Euclidean distance is defined as the distance between two points. Differences between samples were determined on the basis of distances from the initial measurements to account for participant-level differences in initial abundance of microorganisms.

Outcome measures

Outcome measures
Measure	Full Study Cohort n=10 Participants This study includes three sequential phases: 1. Pre-treatment phase: 8 weeks during which no treatment was administered 2. p-Inulin phase: 12 weeks during which p-inulin was administered 8g orally twice daily 3. Post-treatment phase: 8 weeks during which no treatment was administered	Week 4 Week 4 Visit, pre-treatment phase	Week 8 Week 8 visit, pre-treatment phase	Week 12 Week 12 visit, treatment phase	Week 16 Week 16 visit, treatment phase	Week 20 Week 20 visit, treatment phase	Week 24 Week 24 visit, post-treatment phase	Week 28 Week 28 visit, post-treatment phase
Within Participant Variability in Plasma Metabolome by Treatment Phase pre-treatment	9.48 Euclidean distance Interval 8.04 to 10.59	—	—	—	—	—	—	—
Within Participant Variability in Plasma Metabolome by Treatment Phase treatment	9.47 Euclidean distance Interval 8.77 to 10.6	—	—	—	—	—	—	—
Within Participant Variability in Plasma Metabolome by Treatment Phase post-treatment	9.72 Euclidean distance Interval 8.76 to 11.09	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: GSRS was assessed at Weeks 0, 4, 8, 12, 16, 20, 24 and 28.

Population: Two participants withdrew at the beginning of the second phase of the trial.

Gastrointestinal symptoms as measure by the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS total score is the sum of 15 0-3 items where 0 indicates absence and 3 an extreme degree of the symptom. A higher score indicates worse outcome. The minimum score is 0, the maximum score is 45.

Outcome measures

Outcome measures
Measure	Full Study Cohort n=13 Participants This study includes three sequential phases: 1. Pre-treatment phase: 8 weeks during which no treatment was administered 2. p-Inulin phase: 12 weeks during which p-inulin was administered 8g orally twice daily 3. Post-treatment phase: 8 weeks during which no treatment was administered	Week 4 n=13 Participants Week 4 Visit, pre-treatment phase	Week 8 n=13 Participants Week 8 visit, pre-treatment phase	Week 12 n=11 Participants Week 12 visit, treatment phase	Week 16 n=11 Participants Week 16 visit, treatment phase	Week 20 n=11 Participants Week 20 visit, treatment phase	Week 24 n=11 Participants Week 24 visit, post-treatment phase	Week 28 n=11 Participants Week 28 visit, post-treatment phase
Change in Score of Gastrointestinal Symptom Rating Scale (GSRS) (Safety Outcome)	5.69 score on a scale Standard Deviation 3.35	6.23 score on a scale Standard Deviation 3.65	3.68 score on a scale Standard Deviation 5.36	4.36 score on a scale Standard Deviation 3.75	6.00 score on a scale Standard Deviation 6.47	5.27 score on a scale Standard Deviation 5.37	3.45 score on a scale Standard Deviation 2.77	3.91 score on a scale Standard Deviation 2.59

SECONDARY outcome

Timeframe: 12 weeks

Population: This outcome is only relevant during the p-inulin phase.

-Early discontinuation of p-inulin

Outcome measures

Outcome measures
Measure	Full Study Cohort This study includes three sequential phases: 1. Pre-treatment phase: 8 weeks during which no treatment was administered 2. p-Inulin phase: 12 weeks during which p-inulin was administered 8g orally twice daily 3. Post-treatment phase: 8 weeks during which no treatment was administered	Week 4 n=11 Participants Week 4 Visit, pre-treatment phase	Week 8 Week 8 visit, pre-treatment phase	Week 12 Week 12 visit, treatment phase	Week 16 Week 16 visit, treatment phase	Week 20 Week 20 visit, treatment phase	Week 24 Week 24 visit, post-treatment phase	Week 28 Week 28 visit, post-treatment phase
Number of Participants Who Discontinued Use of P-inulin (Tolerability Outcome)	0 Participants	0 Participants	0 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 weeks

Population: Three participants reduced their p-inulin dose. This analysis only applies to the 12 week treatment arm.

-Reduction in p-inulin dose

Outcome measures

Outcome measures
Measure	Full Study Cohort This study includes three sequential phases: 1. Pre-treatment phase: 8 weeks during which no treatment was administered 2. p-Inulin phase: 12 weeks during which p-inulin was administered 8g orally twice daily 3. Post-treatment phase: 8 weeks during which no treatment was administered	Week 4 n=11 Participants Week 4 Visit, pre-treatment phase	Week 8 Week 8 visit, pre-treatment phase	Week 12 Week 12 visit, treatment phase	Week 16 Week 16 visit, treatment phase	Week 20 Week 20 visit, treatment phase	Week 24 Week 24 visit, post-treatment phase	Week 28 Week 28 visit, post-treatment phase
Number of Participants Who Reduce the Dose of P-inulin (Tolerability Outcome)	0 Participants	3 Participants	0 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 28 weeks

-Adverse events per participant related to treatment as coded using the Medical Dictionary for Regulatory Activities (MedDRA) Coding System

Outcome measures

Outcome measures
Measure	Full Study Cohort n=13 Participants This study includes three sequential phases: 1. Pre-treatment phase: 8 weeks during which no treatment was administered 2. p-Inulin phase: 12 weeks during which p-inulin was administered 8g orally twice daily 3. Post-treatment phase: 8 weeks during which no treatment was administered	Week 4 n=11 Participants Week 4 Visit, pre-treatment phase	Week 8 n=11 Participants Week 8 visit, pre-treatment phase	Week 12 Week 12 visit, treatment phase	Week 16 Week 16 visit, treatment phase	Week 20 Week 20 visit, treatment phase	Week 24 Week 24 visit, post-treatment phase	Week 28 Week 28 visit, post-treatment phase
Number of Participants With Adverse Events (Safety Outcome)	1 participants	2 participants	0 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 28 weeks

Population: This is a sequential trial. The 13 participants from the pre-treatment phase moved to the p-inulin phase. Eleven of the 13 participants entered the post-treatment phase. Two participants withdrew prior to the post-treatment phase.

Serious adverse events categorized by body systems, related to treatment as coded using the Medical Dictionary for Regulatory Activities (MedDRA) Coding System

Outcome measures

Outcome measures
Measure	Full Study Cohort n=13 Participants This study includes three sequential phases: 1. Pre-treatment phase: 8 weeks during which no treatment was administered 2. p-Inulin phase: 12 weeks during which p-inulin was administered 8g orally twice daily 3. Post-treatment phase: 8 weeks during which no treatment was administered	Week 4 n=11 Participants Week 4 Visit, pre-treatment phase	Week 8 n=11 Participants Week 8 visit, pre-treatment phase	Week 12 Week 12 visit, treatment phase	Week 16 Week 16 visit, treatment phase	Week 20 Week 20 visit, treatment phase	Week 24 Week 24 visit, post-treatment phase	Week 28 Week 28 visit, post-treatment phase
Number of Serious Adverse Events (Safety Outcome)	3 Serious Adverse Events	0 Serious Adverse Events	1 Serious Adverse Events	—	—	—	—	—

SECONDARY outcome

Timeframe: 1 year

Population: Data not collected

Enrollment refusal rate

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 weeks

Population: This is a sequential trial. The 13 participants from the pre-treatment phase moved to the p-inulin phase. Eleven of the 13 participants entered the post-treatment phase. Two participants withdrew prior to the post-treatment arm.

Percent of expected completed protocol-specified stool sample collections

Outcome measures

Outcome measures
Measure	Full Study Cohort n=13 Participants This study includes three sequential phases: 1. Pre-treatment phase: 8 weeks during which no treatment was administered 2. p-Inulin phase: 12 weeks during which p-inulin was administered 8g orally twice daily 3. Post-treatment phase: 8 weeks during which no treatment was administered	Week 4 n=11 Participants Week 4 Visit, pre-treatment phase	Week 8 n=11 Participants Week 8 visit, pre-treatment phase	Week 12 Week 12 visit, treatment phase	Week 16 Week 16 visit, treatment phase	Week 20 Week 20 visit, treatment phase	Week 24 Week 24 visit, post-treatment phase	Week 28 Week 28 visit, post-treatment phase
Stool Specimen Collection Proportion - Protocol Adherence (Feasibility Outcome)	97 percentage of expected	100 percentage of expected	97 percentage of expected	—	—	—	—	—

SECONDARY outcome

Timeframe: 28 weeks

Population: This is a sequential trial. The 13 participants from the pre-treatment phase moved to the p-inulin phase. Eleven of the 13 participants entered the post-treatment phase. Two participants withdrew prior to the post-treatment phase.

Proportion of completed blood sample collections

Outcome measures

Outcome measures
Measure	Full Study Cohort n=13 Participants This study includes three sequential phases: 1. Pre-treatment phase: 8 weeks during which no treatment was administered 2. p-Inulin phase: 12 weeks during which p-inulin was administered 8g orally twice daily 3. Post-treatment phase: 8 weeks during which no treatment was administered	Week 4 n=11 Participants Week 4 Visit, pre-treatment phase	Week 8 n=11 Participants Week 8 visit, pre-treatment phase	Week 12 Week 12 visit, treatment phase	Week 16 Week 16 visit, treatment phase	Week 20 Week 20 visit, treatment phase	Week 24 Week 24 visit, post-treatment phase	Week 28 Week 28 visit, post-treatment phase
Blood Specimen Collection Proportion - Protocol Adherence (Feasibility Outcome)	99 percentage of expected	100 percentage of expected	94 percentage of expected	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 weeks

Population: This is a sequential trial. The 13 participants from the pre-treatment phase moved to the p-inulin phase. Eleven of the 13 participants entered the post-treatment phase. Two participants withdrew prior to the post-treatment phase.

Proportion of p-inulin packets used

Outcome measures

Outcome measures
Measure	Full Study Cohort n=13 Participants This study includes three sequential phases: 1. Pre-treatment phase: 8 weeks during which no treatment was administered 2. p-Inulin phase: 12 weeks during which p-inulin was administered 8g orally twice daily 3. Post-treatment phase: 8 weeks during which no treatment was administered	Week 4 n=11 Participants Week 4 Visit, pre-treatment phase	Week 8 n=11 Participants Week 8 visit, pre-treatment phase	Week 12 Week 12 visit, treatment phase	Week 16 Week 16 visit, treatment phase	Week 20 Week 20 visit, treatment phase	Week 24 Week 24 visit, post-treatment phase	Week 28 Week 28 visit, post-treatment phase
Adherence Rate of P-inulin Use (Feasibility Outcome)	0 percent	89.5 percent	0 percent	—	—	—	—	—

SECONDARY outcome

Timeframe: 28 weeks

Number of withdrawals during each phase of the study

Outcome measures

Outcome measures
Measure	Full Study Cohort n=13 Participants This study includes three sequential phases: 1. Pre-treatment phase: 8 weeks during which no treatment was administered 2. p-Inulin phase: 12 weeks during which p-inulin was administered 8g orally twice daily 3. Post-treatment phase: 8 weeks during which no treatment was administered	Week 4 n=11 Participants Week 4 Visit, pre-treatment phase	Week 8 n=11 Participants Week 8 visit, pre-treatment phase	Week 12 Week 12 visit, treatment phase	Week 16 Week 16 visit, treatment phase	Week 20 Week 20 visit, treatment phase	Week 24 Week 24 visit, post-treatment phase	Week 28 Week 28 visit, post-treatment phase
Rate of Study Withdrawal (Feasibility Outcome)	0 Participants	2 Participants	0 Participants	—	—	—	—	—

Adverse Events

Pre-treatment

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

P-inulin

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Post-treatment

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pre-treatment n=13 participants at risk This arm is the 8-week observation period before the p-inulin treatment phase.	P-inulin n=11 participants at risk This arm is the 12 week p-inulin treatment phase (8 grams twice daily, oral). p-inulin: 12 week self-administered treatment phase	Post-treatment n=11 participants at risk This arm is the 8-week observation period after the p-inulin treatment phase.
Injury, poisoning and procedural complications Graft thrombosis	7.7% 1/13 • Number of events 1 • 28 weeks from Baseline to End of Study This is a sequential trial. The 13 participants from the pre-treatment phase moved to the p-inulin phase. Eleven of the 13 participants entered the post-treatment phase. Two participants withdrew prior to the post-treatment phase.	0.00% 0/11 • 28 weeks from Baseline to End of Study This is a sequential trial. The 13 participants from the pre-treatment phase moved to the p-inulin phase. Eleven of the 13 participants entered the post-treatment phase. Two participants withdrew prior to the post-treatment phase.	0.00% 0/11 • 28 weeks from Baseline to End of Study This is a sequential trial. The 13 participants from the pre-treatment phase moved to the p-inulin phase. Eleven of the 13 participants entered the post-treatment phase. Two participants withdrew prior to the post-treatment phase.
Injury, poisoning and procedural complications Graft dysfunction	0.00% 0/13 • 28 weeks from Baseline to End of Study This is a sequential trial. The 13 participants from the pre-treatment phase moved to the p-inulin phase. Eleven of the 13 participants entered the post-treatment phase. Two participants withdrew prior to the post-treatment phase.	0.00% 0/11 • 28 weeks from Baseline to End of Study This is a sequential trial. The 13 participants from the pre-treatment phase moved to the p-inulin phase. Eleven of the 13 participants entered the post-treatment phase. Two participants withdrew prior to the post-treatment phase.	9.1% 1/11 • Number of events 1 • 28 weeks from Baseline to End of Study This is a sequential trial. The 13 participants from the pre-treatment phase moved to the p-inulin phase. Eleven of the 13 participants entered the post-treatment phase. Two participants withdrew prior to the post-treatment phase.
Ear and labyrinth disorders Vertigo	7.7% 1/13 • Number of events 2 • 28 weeks from Baseline to End of Study This is a sequential trial. The 13 participants from the pre-treatment phase moved to the p-inulin phase. Eleven of the 13 participants entered the post-treatment phase. Two participants withdrew prior to the post-treatment phase.	0.00% 0/11 • 28 weeks from Baseline to End of Study This is a sequential trial. The 13 participants from the pre-treatment phase moved to the p-inulin phase. Eleven of the 13 participants entered the post-treatment phase. Two participants withdrew prior to the post-treatment phase.	0.00% 0/11 • 28 weeks from Baseline to End of Study This is a sequential trial. The 13 participants from the pre-treatment phase moved to the p-inulin phase. Eleven of the 13 participants entered the post-treatment phase. Two participants withdrew prior to the post-treatment phase.

Other adverse events

Other adverse events
Measure	Pre-treatment n=13 participants at risk This arm is the 8-week observation period before the p-inulin treatment phase.	P-inulin n=11 participants at risk This arm is the 12 week p-inulin treatment phase (8 grams twice daily, oral). p-inulin: 12 week self-administered treatment phase	Post-treatment n=11 participants at risk This arm is the 8-week observation period after the p-inulin treatment phase.
Ear and labyrinth disorders Vertigo	7.7% 1/13 • Number of events 2 • 28 weeks from Baseline to End of Study This is a sequential trial. The 13 participants from the pre-treatment phase moved to the p-inulin phase. Eleven of the 13 participants entered the post-treatment phase. Two participants withdrew prior to the post-treatment phase.	0.00% 0/11 • 28 weeks from Baseline to End of Study This is a sequential trial. The 13 participants from the pre-treatment phase moved to the p-inulin phase. Eleven of the 13 participants entered the post-treatment phase. Two participants withdrew prior to the post-treatment phase.	0.00% 0/11 • 28 weeks from Baseline to End of Study This is a sequential trial. The 13 participants from the pre-treatment phase moved to the p-inulin phase. Eleven of the 13 participants entered the post-treatment phase. Two participants withdrew prior to the post-treatment phase.
Gastrointestinal disorders Diarrhea	0.00% 0/13 • 28 weeks from Baseline to End of Study This is a sequential trial. The 13 participants from the pre-treatment phase moved to the p-inulin phase. Eleven of the 13 participants entered the post-treatment phase. Two participants withdrew prior to the post-treatment phase.	9.1% 1/11 • Number of events 1 • 28 weeks from Baseline to End of Study This is a sequential trial. The 13 participants from the pre-treatment phase moved to the p-inulin phase. Eleven of the 13 participants entered the post-treatment phase. Two participants withdrew prior to the post-treatment phase.	0.00% 0/11 • 28 weeks from Baseline to End of Study This is a sequential trial. The 13 participants from the pre-treatment phase moved to the p-inulin phase. Eleven of the 13 participants entered the post-treatment phase. Two participants withdrew prior to the post-treatment phase.
Respiratory, thoracic and mediastinal disorders Shortness of breath	0.00% 0/13 • 28 weeks from Baseline to End of Study This is a sequential trial. The 13 participants from the pre-treatment phase moved to the p-inulin phase. Eleven of the 13 participants entered the post-treatment phase. Two participants withdrew prior to the post-treatment phase.	9.1% 1/11 • Number of events 1 • 28 weeks from Baseline to End of Study This is a sequential trial. The 13 participants from the pre-treatment phase moved to the p-inulin phase. Eleven of the 13 participants entered the post-treatment phase. Two participants withdrew prior to the post-treatment phase.	0.00% 0/11 • 28 weeks from Baseline to End of Study This is a sequential trial. The 13 participants from the pre-treatment phase moved to the p-inulin phase. Eleven of the 13 participants entered the post-treatment phase. Two participants withdrew prior to the post-treatment phase.

Additional Information

Natalie Kuzla

University of Pennsylvania

Phone: 215-573-2935

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place