Trial Outcomes & Findings for Effects of rhLactoferrin on Chronic Inflammation in the Elderly (NCT NCT02968992)
NCT ID: NCT02968992
Last Updated: 2023-10-03
Results Overview
The effect of rhlactoferrin on serum levels (picogram/milliliter) of Interleukin-6 (IL-6) will be assessed as a measure of the percentage change of IL-6 serum levels from baseline
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Baseline and 6 months
Results posted on
2023-10-03
Participant Flow
Participant milestones
| Measure |
rhLactoferrin
rH lactoferrin will be provided by Ventria Biosciences. Each capsule will contain 250 mg of rH lactoferrin as active ingredient. Subjects will receive 1500 mg of lactoferrin in capsule form twice a day. Dosing will be six 250 mg capsules twice a day for six months.
rhLactoferrin: Eligible participants will be provided with Recombinant Human lactoferrin (rhLF) in 250 mg capsules along with detailed instructions for taking the study drug and they will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.
|
Placebo
Matching placebo capsule will be provided by Ventria Biosciences and six capsules twice a day will be provided to the subjects in this arm.
Placebo: Eligible participant will be provided with placebo in capsules of 250 mg along with detailed instructions for taking the placebo. Participants will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
18
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A total of 36 participants entered the study. One participant in the placebo group later dropped out and therefore was not included in the analysis.
Baseline characteristics by cohort
| Measure |
rhLactoferrin
n=18 Participants
rH lactoferrin will be provided by Ventria Biosciences. Each capsule will contain 250 mg of rH lactoferrin as active ingredient. Subjects will receive 1500 mg of lactoferrin in capsule form twice a day. Dosing will be six 250 mg capsules twice a day for six months.
rhLactoferrin: Eligible participants will be provided with Recombinant Human lactoferrin (rhLF) in 250 mg capsules along with detailed instructions for taking the study drug and they will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.
|
Placebo
n=18 Participants
Matching placebo capsule will be provided by Ventria Biosciences and six capsules twice a day will be provided to the subjects in this arm.
Placebo: Eligible participant will be provided with placebo in capsules of 250 mg along with detailed instructions for taking the placebo. Participants will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=18 Participants
|
18 Participants
n=18 Participants
|
36 Participants
n=36 Participants
|
|
Age, Continuous
|
82.6 years
STANDARD_DEVIATION 6.6 • n=18 Participants
|
79.6 years
STANDARD_DEVIATION 5.6 • n=18 Participants
|
81.1 years
STANDARD_DEVIATION 6.21 • n=36 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=18 Participants
|
11 Participants
n=18 Participants
|
22 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=18 Participants
|
7 Participants
n=18 Participants
|
14 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=18 Participants
|
17 Participants
n=18 Participants
|
34 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=18 Participants
|
1 Participants
n=18 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=18 Participants
|
3 Participants
n=18 Participants
|
6 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=18 Participants
|
15 Participants
n=18 Participants
|
29 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=36 Participants
|
|
BMI
BMI ≥ 30
|
5 Participants
n=18 Participants
|
8 Participants
n=18 Participants
|
13 Participants
n=36 Participants
|
|
BMI
BMI < 30
|
13 Participants
n=18 Participants
|
10 Participants
n=18 Participants
|
23 Participants
n=36 Participants
|
|
Physical mobility as measured by 4 meter walk test
|
0.78 m/sec
STANDARD_DEVIATION 0.17 • n=18 Participants • A total of 36 participants entered the study. One participant in the placebo group later dropped out and therefore was not included in the analysis.
|
0.78 m/sec
STANDARD_DEVIATION 0.13 • n=17 Participants • A total of 36 participants entered the study. One participant in the placebo group later dropped out and therefore was not included in the analysis.
|
0.78 m/sec
STANDARD_DEVIATION 0.15 • n=35 Participants • A total of 36 participants entered the study. One participant in the placebo group later dropped out and therefore was not included in the analysis.
|
|
Physical strength as measured by grip strength
|
26.2 kg
STANDARD_DEVIATION 7.3 • n=18 Participants • A total of 36 participants entered the study. One participant in the placebo group later dropped out and therefore was not included in the analysis.
|
25.3 kg
STANDARD_DEVIATION 6.7 • n=17 Participants • A total of 36 participants entered the study. One participant in the placebo group later dropped out and therefore was not included in the analysis.
|
25.8 kg
STANDARD_DEVIATION 6.9 • n=35 Participants • A total of 36 participants entered the study. One participant in the placebo group later dropped out and therefore was not included in the analysis.
|
|
Physical mobility as measured by 6 minute walk test
|
358.9 meters
STANDARD_DEVIATION 124.3 • n=17 Participants • A total of 36 participants entered the study. One participant in the placebo group later dropped out and therefore was not included in the analysis. One participant in the treatment group declined to complete the test.
|
345.8 meters
STANDARD_DEVIATION 88.9 • n=17 Participants • A total of 36 participants entered the study. One participant in the placebo group later dropped out and therefore was not included in the analysis. One participant in the treatment group declined to complete the test.
|
352.3 meters
STANDARD_DEVIATION 106.6 • n=34 Participants • A total of 36 participants entered the study. One participant in the placebo group later dropped out and therefore was not included in the analysis. One participant in the treatment group declined to complete the test.
|
|
Log Total Activity Count
|
14.26 Log Total Activity Count
STANDARD_DEVIATION 0.35 • n=18 Participants • A total of 36 participants entered the study, one participant in the placebo group later dropped out and therefore was not included in the analysis.
|
14.46 Log Total Activity Count
STANDARD_DEVIATION 0.28 • n=17 Participants • A total of 36 participants entered the study, one participant in the placebo group later dropped out and therefore was not included in the analysis.
|
14.35 Log Total Activity Count
STANDARD_DEVIATION 0.33 • n=35 Participants • A total of 36 participants entered the study, one participant in the placebo group later dropped out and therefore was not included in the analysis.
|
|
Attenuating cognitive decline as measured by the trail making test A and B
Test A
|
48.3 seconds
STANDARD_DEVIATION 16.7 • n=18 Participants • A total of 36 participants entered the study. One participant in the placebo group later dropped out and therefore was not included in the analysis of test A and test B data. One additional participant in the placebo group was unable to complete Trail Making Test B, so they were not included in the analysis.
|
54.1 seconds
STANDARD_DEVIATION 28.9 • n=17 Participants • A total of 36 participants entered the study. One participant in the placebo group later dropped out and therefore was not included in the analysis of test A and test B data. One additional participant in the placebo group was unable to complete Trail Making Test B, so they were not included in the analysis.
|
51.1 seconds
STANDARD_DEVIATION 23.3 • n=35 Participants • A total of 36 participants entered the study. One participant in the placebo group later dropped out and therefore was not included in the analysis of test A and test B data. One additional participant in the placebo group was unable to complete Trail Making Test B, so they were not included in the analysis.
|
|
Attenuating cognitive decline as measured by the trail making test A and B
Test B
|
101.1 seconds
STANDARD_DEVIATION 34.6 • n=18 Participants • A total of 36 participants entered the study. One participant in the placebo group later dropped out and therefore was not included in the analysis of test A and test B data. One additional participant in the placebo group was unable to complete Trail Making Test B, so they were not included in the analysis.
|
109.3 seconds
STANDARD_DEVIATION 49.3 • n=16 Participants • A total of 36 participants entered the study. One participant in the placebo group later dropped out and therefore was not included in the analysis of test A and test B data. One additional participant in the placebo group was unable to complete Trail Making Test B, so they were not included in the analysis.
|
104.9 seconds
STANDARD_DEVIATION 41.7 • n=34 Participants • A total of 36 participants entered the study. One participant in the placebo group later dropped out and therefore was not included in the analysis of test A and test B data. One additional participant in the placebo group was unable to complete Trail Making Test B, so they were not included in the analysis.
|
|
Attenuating cognitive decline as measured by the digital symbol substitution test
|
33 Correct answers
STANDARD_DEVIATION 12 • n=18 Participants • A total of 36 participants entered the study. One participant in the placebo group later dropped out and therefore was not included in the analysis.
|
31 Correct answers
STANDARD_DEVIATION 10 • n=17 Participants • A total of 36 participants entered the study. One participant in the placebo group later dropped out and therefore was not included in the analysis.
|
32 Correct answers
STANDARD_DEVIATION 11 • n=35 Participants • A total of 36 participants entered the study. One participant in the placebo group later dropped out and therefore was not included in the analysis.
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsThe effect of rhlactoferrin on serum levels (picogram/milliliter) of Interleukin-6 (IL-6) will be assessed as a measure of the percentage change of IL-6 serum levels from baseline
Outcome measures
| Measure |
rhLactoferrin
n=18 Participants
rH lactoferrin will be provided by Ventria Biosciences. Each capsule will contain 250 mg of rH lactoferrin as active ingredient. Subjects will receive 1500 mg of lactoferrin in capsule form twice a day. Dosing will be six 250 mg capsules twice a day for six months.
rhLactoferrin: Eligible participants will be provided with Recombinant Human lactoferrin (rhLF) in 250 mg capsules along with detailed instructions for taking the study drug and they will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.
|
Placebo
n=17 Participants
Matching placebo capsule will be provided by Ventria Biosciences and six capsules twice a day will be provided to the subjects in this arm.
Placebo: Eligible participant will be provided with placebo in capsules of 250 mg along with detailed instructions for taking the placebo. Participants will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.
|
|---|---|---|
|
The Effect of Rhlactoferrin on Serum Levels of Interleukin-6 (IL-6)
|
-0.640 Percent change of IL-6
Standard Deviation 1.137
|
0.932 Percent change of IL-6
Standard Deviation 0.265
|
PRIMARY outcome
Timeframe: From baseline to 6 monthsThe effect of rhlactoferrin on serum levels (picogram/milliliter) of tumor necrosis factor alpha receptor 1 (TNFR1) assessed as a measure of the percentage change of serum TNFR1 levels from baseline
Outcome measures
| Measure |
rhLactoferrin
n=18 Participants
rH lactoferrin will be provided by Ventria Biosciences. Each capsule will contain 250 mg of rH lactoferrin as active ingredient. Subjects will receive 1500 mg of lactoferrin in capsule form twice a day. Dosing will be six 250 mg capsules twice a day for six months.
rhLactoferrin: Eligible participants will be provided with Recombinant Human lactoferrin (rhLF) in 250 mg capsules along with detailed instructions for taking the study drug and they will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.
|
Placebo
n=17 Participants
Matching placebo capsule will be provided by Ventria Biosciences and six capsules twice a day will be provided to the subjects in this arm.
Placebo: Eligible participant will be provided with placebo in capsules of 250 mg along with detailed instructions for taking the placebo. Participants will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.
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|---|---|---|
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The Effect of Rhlactoferrin on Serum Levels of Tumor Necrosis Factor Alpha Receptor 1 (TNFR1)
|
19.709 Percent change from baseline
Standard Deviation 85.084
|
140.748 Percent change from baseline
Standard Deviation 43.24
|
SECONDARY outcome
Timeframe: At 6 monthsThe test taker is given a key consisting of numbers 1-9 that are paired with a unique symbol. The test taker is allowed 90 seconds to assign the correct symbol to the number on the list. The test administrator then scores the number of correct answers over the 90 second test time, and assigns a total score based on one point for each correct answer and therefore a higher score is a better outcome.
Outcome measures
| Measure |
rhLactoferrin
n=18 Participants
rH lactoferrin will be provided by Ventria Biosciences. Each capsule will contain 250 mg of rH lactoferrin as active ingredient. Subjects will receive 1500 mg of lactoferrin in capsule form twice a day. Dosing will be six 250 mg capsules twice a day for six months.
rhLactoferrin: Eligible participants will be provided with Recombinant Human lactoferrin (rhLF) in 250 mg capsules along with detailed instructions for taking the study drug and they will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.
|
Placebo
n=17 Participants
Matching placebo capsule will be provided by Ventria Biosciences and six capsules twice a day will be provided to the subjects in this arm.
Placebo: Eligible participant will be provided with placebo in capsules of 250 mg along with detailed instructions for taking the placebo. Participants will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.
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|---|---|---|
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Attenuating Cognitive Decline as Measured by the Digital Symbol Substitution Test
|
31.61 correct responses
Interval 26.07 to 37.16
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31 correct responses
Interval 25.42 to 36.58
|
SECONDARY outcome
Timeframe: At 6 monthsPopulation: A total of 36 participants entered the study. One participant in the placebo group later dropped out and therefore was not included in the analysis. One additional participant in the placebo group was unable to complete Trail Making Test B, so they were not included in the analysis.
For test A, the test taker is given a sheet of paper that has the numbers 1-25 within individual circles randomly distributed on the page. The test taker is asked to connect the numbers sequentially over a period of 4 minutes (240 seconds). The score is recorded as the time it takes to complete the task in seconds. For test B, the test taker is given a piece of paper that has numbers 1-13 and letters A-L. Each letter or number is inside of a circle. The test taker must then draw a line from one circled number to the next circled letter (ie. 1 to A to 2 to B to 3 to C etc.) over a period of 6 minutes (360 seconds). The time it takes to complete this task is recorded in seconds.
Outcome measures
| Measure |
rhLactoferrin
n=18 Participants
rH lactoferrin will be provided by Ventria Biosciences. Each capsule will contain 250 mg of rH lactoferrin as active ingredient. Subjects will receive 1500 mg of lactoferrin in capsule form twice a day. Dosing will be six 250 mg capsules twice a day for six months.
rhLactoferrin: Eligible participants will be provided with Recombinant Human lactoferrin (rhLF) in 250 mg capsules along with detailed instructions for taking the study drug and they will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.
|
Placebo
n=17 Participants
Matching placebo capsule will be provided by Ventria Biosciences and six capsules twice a day will be provided to the subjects in this arm.
Placebo: Eligible participant will be provided with placebo in capsules of 250 mg along with detailed instructions for taking the placebo. Participants will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.
|
|---|---|---|
|
Attenuating Cognitive Decline as Measured by the Trail Making Test A and B.
Trail Making Test A
|
33.11 seconds
Interval 26.36 to 39.85
|
42.68 seconds
Interval 35.89 to 49.47
|
|
Attenuating Cognitive Decline as Measured by the Trail Making Test A and B.
Trail Making Test B
|
122.73 seconds
Interval 92.31 to 153.14
|
131.24 seconds
Interval 100.61 to 161.87
|
SECONDARY outcome
Timeframe: At 6 monthsA standard measurement of 4 meters is marked on a flat, long floor surface. The test taker is asked to walk the length at their usual pace while the test giver is recording the time with a stop watch. This test is repeated twice, and the average of the two recorded times is used as the data point.
Outcome measures
| Measure |
rhLactoferrin
n=18 Participants
rH lactoferrin will be provided by Ventria Biosciences. Each capsule will contain 250 mg of rH lactoferrin as active ingredient. Subjects will receive 1500 mg of lactoferrin in capsule form twice a day. Dosing will be six 250 mg capsules twice a day for six months.
rhLactoferrin: Eligible participants will be provided with Recombinant Human lactoferrin (rhLF) in 250 mg capsules along with detailed instructions for taking the study drug and they will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.
|
Placebo
n=17 Participants
Matching placebo capsule will be provided by Ventria Biosciences and six capsules twice a day will be provided to the subjects in this arm.
Placebo: Eligible participant will be provided with placebo in capsules of 250 mg along with detailed instructions for taking the placebo. Participants will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.
|
|---|---|---|
|
Physical Mobility as Measured by 4 Meter Walk Test
|
0.786 m/sec
Interval 0.701 to 0.871
|
0.767 m/sec
Interval 0.681 to 0.852
|
SECONDARY outcome
Timeframe: At 6 monthsA measured course is set up in an open area on a hard flat surface. The test taker walks on this measured course for 6 minutes, and the test administrators calculates the distance traveled over 6 minutes. The test taker is allowed to rest as is needed.
Outcome measures
| Measure |
rhLactoferrin
n=18 Participants
rH lactoferrin will be provided by Ventria Biosciences. Each capsule will contain 250 mg of rH lactoferrin as active ingredient. Subjects will receive 1500 mg of lactoferrin in capsule form twice a day. Dosing will be six 250 mg capsules twice a day for six months.
rhLactoferrin: Eligible participants will be provided with Recombinant Human lactoferrin (rhLF) in 250 mg capsules along with detailed instructions for taking the study drug and they will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.
|
Placebo
n=17 Participants
Matching placebo capsule will be provided by Ventria Biosciences and six capsules twice a day will be provided to the subjects in this arm.
Placebo: Eligible participant will be provided with placebo in capsules of 250 mg along with detailed instructions for taking the placebo. Participants will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.
|
|---|---|---|
|
Physical Mobility as Measured by 6 Minute Walk Test
|
359.66 meter
Interval 303.02 to 416.3
|
334.94 meter
Interval 279.48 to 390.4
|
SECONDARY outcome
Timeframe: From baseline through 6 months.Study coordinators administered side effect questionnaire at each visit and via phone every two weeks during the treatment period.
Outcome measures
| Measure |
rhLactoferrin
n=18 Participants
rH lactoferrin will be provided by Ventria Biosciences. Each capsule will contain 250 mg of rH lactoferrin as active ingredient. Subjects will receive 1500 mg of lactoferrin in capsule form twice a day. Dosing will be six 250 mg capsules twice a day for six months.
rhLactoferrin: Eligible participants will be provided with Recombinant Human lactoferrin (rhLF) in 250 mg capsules along with detailed instructions for taking the study drug and they will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.
|
Placebo
n=17 Participants
Matching placebo capsule will be provided by Ventria Biosciences and six capsules twice a day will be provided to the subjects in this arm.
Placebo: Eligible participant will be provided with placebo in capsules of 250 mg along with detailed instructions for taking the placebo. Participants will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.
|
|---|---|---|
|
Tolerability of Oral rhLactoferrin as Assessed by Patient Diary of Total Number of Side Effects
|
2.23 Side effects/100 treatment days
Standard Deviation 3.16
|
4.77 Side effects/100 treatment days
Standard Deviation 4.23
|
SECONDARY outcome
Timeframe: At 6 monthsHand grip strength is measured by the amount of static force that the hand can squeeze around a dynamometer. An administrator recorded the reading on the device. The force was measured in kilograms.
Outcome measures
| Measure |
rhLactoferrin
n=18 Participants
rH lactoferrin will be provided by Ventria Biosciences. Each capsule will contain 250 mg of rH lactoferrin as active ingredient. Subjects will receive 1500 mg of lactoferrin in capsule form twice a day. Dosing will be six 250 mg capsules twice a day for six months.
rhLactoferrin: Eligible participants will be provided with Recombinant Human lactoferrin (rhLF) in 250 mg capsules along with detailed instructions for taking the study drug and they will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.
|
Placebo
n=17 Participants
Matching placebo capsule will be provided by Ventria Biosciences and six capsules twice a day will be provided to the subjects in this arm.
Placebo: Eligible participant will be provided with placebo in capsules of 250 mg along with detailed instructions for taking the placebo. Participants will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.
|
|---|---|---|
|
Physical Strength as Measured by Grip Strength
|
23.493 kg
Interval 20.694 to 26.337
|
20.294 kg
Interval 17.34 to 23.157
|
Adverse Events
rhLactoferrin
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
rhLactoferrin
n=18 participants at risk
rH lactoferrin will be provided by Ventria Biosciences. Each capsule will contain 250 mg of rH lactoferrin as active ingredient. Subjects will receive 1500 mg of lactoferrin in capsule form twice a day. Dosing will be six 250 mg capsules twice a day for six months.
rhLactoferrin: Eligible participants will be provided with Recombinant Human lactoferrin (rhLF) in 250 mg capsules along with detailed instructions for taking the study drug and they will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.
|
Placebo
n=18 participants at risk
Matching placebo capsule will be provided by Ventria Biosciences and six capsules twice a day will be provided to the subjects in this arm.
Placebo: Eligible participant will be provided with placebo in capsules of 250 mg along with detailed instructions for taking the placebo. Participants will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.
|
|---|---|---|
|
Infections and infestations
Hospitalization
|
0.00%
0/18 • 6 months
|
5.6%
1/18 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
rhLactoferrin
n=18 participants at risk
rH lactoferrin will be provided by Ventria Biosciences. Each capsule will contain 250 mg of rH lactoferrin as active ingredient. Subjects will receive 1500 mg of lactoferrin in capsule form twice a day. Dosing will be six 250 mg capsules twice a day for six months.
rhLactoferrin: Eligible participants will be provided with Recombinant Human lactoferrin (rhLF) in 250 mg capsules along with detailed instructions for taking the study drug and they will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.
|
Placebo
n=18 participants at risk
Matching placebo capsule will be provided by Ventria Biosciences and six capsules twice a day will be provided to the subjects in this arm.
Placebo: Eligible participant will be provided with placebo in capsules of 250 mg along with detailed instructions for taking the placebo. Participants will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
2/18 • 6 months
|
27.8%
5/18 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
0.00%
0/18 • 6 months
|
5.6%
1/18 • 6 months
|
|
General disorders
Loss of Appetite
|
11.1%
2/18 • 6 months
|
5.6%
1/18 • 6 months
|
|
General disorders
Fatigue
|
27.8%
5/18 • 6 months
|
22.2%
4/18 • 6 months
|
|
General disorders
Fever/chills
|
22.2%
4/18 • 6 months
|
0.00%
0/18 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
16.7%
3/18 • 6 months
|
22.2%
4/18 • 6 months
|
|
General disorders
Other conditions
|
66.7%
12/18 • 6 months
|
50.0%
9/18 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place