ELCIE: Effects of rhLactoferrin on Chronic Inflammation in the Elderly

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02968992
• Collaborator: Ventria Bioscience (Industry)
• Enrollment: 36
• Location: 1
• Arms: 2
• Actual Duration (Months): 18.4
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate how recombinant human lactoferrin (rhLF) which is a partially iron saturated form of lactoferrin produced and purified from rice grain may improve mobility and memory in older adults with chronic inflammation. Lactoferrin, is a known multifunctional protein, and has been shown to have anti-inflammatory effects. A recombinant human version of this protein was recently developed and produced from rice. This is now available from the Ventria Bioscience Company in a controlled, pharmaceutical grade capsule. As part of this double blinded and randomized study, participants will take daily dosages of recombinant human lactoferrin (rhLF) or its matched placebo; to measure the effects of rhlactoferrin on chronic inflammation and its association with improving mobility and memory over a 6 month time period. During the study all participants will be asked to provide blood samples and will have physical and cognitive tests administered to them. By measuring biomarkers in the blood as well as changes in physical and cognitive measures, the investigators will gain an understanding of how rhlactoferrin may safely improve measures of chronic inflammation in older adults. As well as a better understanding of whether it has the potential to meaningfully influence important measures of physical and cognitive function known to be influenced by Chronic Inflammation (CI).

Condition or Disease	Intervention/Treatment	Phase
Inflammation; Cognitive Deterioration	Drug: rhLactoferrin; Other: Placebo	Phase 2

Detailed Description

The primary objective of this study is to examine in a double blinded and randomized trial the efficacy of Recombinant Human lactoferrin (rhLF) in reducing chronic inflammation as measured by IL-6 and sTNFR1 in the bloodstream. The primary end point is to gather information about the tolerability of and adherence to oral rhlactoferrin (rhLF) among older adults with CI over a six-month period. The exploratory objective is to assess the efficacy of rhlactoferrin (rhLF) in attenuating cognitive decline as measured by the Digit Symbol Substitution Test and Trail Making Test, as well as improving physical mobility as measured by performance on 4 meter and six-minute walk tests. Further physical and functional measurement data will be gather using an Acti-graph link Activity monitor, the raw data collected will be used to : (i) characterize cumulative daily activity, (ii) assess daily circadian patterns of activity, (iii) assess physical activity variability, (iv) model patterns of daily activity, and (iv) estimate walking speed. This additional data will complement mobility measures by describing function enacted in daily life

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: •Randomized: Participants are assigned to intervention groups by chance
• Primary Purpose: Treatment
• Official Title: Effects of Lactoferrin on Chronic Inflammation in the Elderly
• Actual Study Start Date: Aug 14, 2017
• Actual Primary Completion Date: Feb 25, 2019
• Actual Study Completion Date: Feb 25, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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 Comparator: 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.	Other: 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.

Outcome Measures

Primary Outcome Measures

1. The Effect of Rhlactoferrin on Serum Levels of Interleukin-6 (IL-6) [Baseline and 6 months]

   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

2. The Effect of Rhlactoferrin on Serum Levels of Tumor Necrosis Factor Alpha Receptor 1 (TNFR1) [From baseline to 6 months]

   The 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

Secondary Outcome Measures

1. Attenuating Cognitive Decline as Measured by the Digital Symbol Substitution Test [At 6 months]

   The 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.

2. Attenuating Cognitive Decline as Measured by the Trail Making Test A and B. [At 6 months]

   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.

3. Physical Mobility as Measured by 4 Meter Walk Test [At 6 months]

   A 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.

4. Physical Mobility as Measured by 6 Minute Walk Test [At 6 months]

   A 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.

5. Tolerability of Oral rhLactoferrin as Assessed by Patient Diary of Total Number of Side Effects [From baseline through 6 months.]

   Study coordinators administered side effect questionnaire at each visit and via phone every two weeks during the treatment period.

6. Physical Strength as Measured by Grip Strength [At 6 months]

   Hand 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 70 and older

• able to complete 4- meter timed walk; walking speed <1.0 m/sec

• serum IL-6 level ≥ 2.5 pg/ml or TNFR1 level ≥1500 pg/ml

Exclusion Criteria:

• Daily anti-inflammatory drug use (prednisone, Advil, Aleve, Remicade, Enbrel, methotrexate, standing nonsteroidal anti-inflammatory drugs (NSAID), aspirin greater than 325 mg per day)

• lower extremity mobility disability caused by Parkinson's disease,

• cerebral vascular accident (CVA) with residual motor deficit,

• severe osteoarthritis or rheumatoid arthritis

• symptomatic claudication

• hospitalization within 3 months for myocardial infarction (MI), angina, infection requiring antibiotics, or joint replacement.

• Mini-Mental State Examination (MMSE) < 21.

• Lactose intolerant

• allergy or intolerance to bovine products

• being a vegan (since vegans will want to avoid Bovine products.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jeremy D. Walston	Baltimore	Maryland	United States	21224

Sponsors and Collaborators

• Johns Hopkins University
• Ventria Bioscience

Investigators

• Principal Investigator: Jerermy D. Walston, MD, Johns Hopkins Universtiy

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 15, 2017

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT02968992
• Other Study ID Numbers: IRB00094982
• First Posted: Nov 21, 2016
• Last Update Posted: Mar 26, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Inflammation

Study Results

Participant Flow

Arm/Group Title	rhLactoferrin	Placebo
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	18	18
COMPLETED	18	17
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	rhLactoferrin	Placebo	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	18	18	36
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	18 100%	18 100%	36 100%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	82.6 (6.6)	79.6 (5.6)	81.1 (6.21)
Sex: Female, Male (Count of Participants)
Female	11 61.1%	11 61.1%	22 61.1%
Male	7 38.9%	7 38.9%	14 38.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	17 94.4%	17 94.4%	34 94.4%
Unknown or Not Reported	1 5.6%	1 5.6%	2 5.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 5.6%	0 0%	1 2.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	3 16.7%	3 16.7%	6 16.7%
White	14 77.8%	15 83.3%	29 80.6%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
BMI (Count of Participants)
BMI ≥ 30	5 27.8%	8 44.4%	13 36.1%
BMI < 30	13 72.2%	10 55.6%	23 63.9%
Physical mobility as measured by 4 meter walk test (m/sec) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [m/sec]	0.78 (0.17)	0.78 (0.13)	0.78 (0.15)
Physical strength as measured by grip strength (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	26.2 (7.3)	25.3 (6.7)	25.8 (6.9)
Physical mobility as measured by 6 minute walk test (meters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [meters]	358.9 (124.3)	345.8 (88.9)	352.3 (106.6)
Log Total Activity Count (Log Total Activity Count) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Log Total Activity Count]	14.26 (0.35)	14.46 (0.28)	14.35 (0.33)
Attenuating cognitive decline as measured by the trail making test A and B (seconds) [Mean (Standard Deviation) ]
Test A	48.3 (16.7)	54.1 (28.9)	51.1 (23.3)
Test B	101.1 (34.6)	109.3 (49.3)	104.9 (41.7)
Attenuating cognitive decline as measured by the digital symbol substitution test (Correct answers) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Correct answers]	33 (12)	31 (10)	32 (11)

Outcome Measures

1. Primary Outcome

Title	The Effect of Rhlactoferrin on Serum Levels of Interleukin-6 (IL-6)
Description	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
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	rhLactoferrin	Placebo
Arm/Group Description	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.	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.
Measure Participants	18	17
Mean (Standard Deviation) [Percent change of IL-6]	-0.640 (1.137)	0.932 (0.265)

2. Primary Outcome

Title	The Effect of Rhlactoferrin on Serum Levels of Tumor Necrosis Factor Alpha Receptor 1 (TNFR1)
Description	The 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
Time Frame	From baseline to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	rhLactoferrin	Placebo
Arm/Group Description	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.	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.
Measure Participants	18	17
Mean (Standard Deviation) [Percent change from baseline]	19.709 (85.084)	140.748 (43.24)

3. Secondary Outcome

Title	Attenuating Cognitive Decline as Measured by the Digital Symbol Substitution Test
Description	The 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.
Time Frame	At 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	rhLactoferrin	Placebo
Arm/Group Description	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.	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.
Measure Participants	18	17
Mean (95% Confidence Interval) [correct responses]	31.61	31

4. Secondary Outcome

Title	Attenuating Cognitive Decline as Measured by the Trail Making Test A and B.
Description	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.
Time Frame	At 6 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	rhLactoferrin	Placebo
Arm/Group Description	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.	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.
Measure Participants	18	17
Trail Making Test A	33.11	42.68
Trail Making Test B	122.73	131.24

5. Secondary Outcome

Title	Physical Mobility as Measured by 4 Meter Walk Test
Description	A 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.
Time Frame	At 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	rhLactoferrin	Placebo
Arm/Group Description	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.	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.
Measure Participants	18	17
Mean (95% Confidence Interval) [m/sec]	0.786	0.767

6. Secondary Outcome

Title	Physical Mobility as Measured by 6 Minute Walk Test
Description	A 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.
Time Frame	At 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	rhLactoferrin	Placebo
Arm/Group Description	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.	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.
Measure Participants	18	17
Mean (95% Confidence Interval) [meter]	359.66	334.94

7. Secondary Outcome

Title	Tolerability of Oral rhLactoferrin as Assessed by Patient Diary of Total Number of Side Effects
Description	Study coordinators administered side effect questionnaire at each visit and via phone every two weeks during the treatment period.
Time Frame	From baseline through 6 months.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	rhLactoferrin	Placebo
Arm/Group Description	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.	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.
Measure Participants	18	17
Mean (Standard Deviation) [Side effects/100 treatment days]	2.23 (3.16)	4.77 (4.23)

8. Secondary Outcome

Title	Physical Strength as Measured by Grip Strength
Description	Hand 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.
Time Frame	At 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	rhLactoferrin	Placebo
Arm/Group Description	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.	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.
Measure Participants	18	17
Mean (95% Confidence Interval) [kg]	23.493	20.294

Adverse Events

Time Frame	6 months
Arm/Group Title	rhLactoferrin		Placebo
Arm/Group Description	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.		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.
All Cause Mortality
	rhLactoferrin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/18 (0%)
Serious Adverse Events
	rhLactoferrin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		1/18 (5.6%)
Infections and infestations
Hospitalization	0/18 (0%)	0	1/18 (5.6%)	1
Other (Not Including Serious) Adverse Events
	rhLactoferrin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/18 (72.2%)		15/18 (83.3%)
Gastrointestinal disorders
Diarrhea	2/18 (11.1%)		5/18 (27.8%)
Constipation	3/18 (16.7%)		4/18 (22.2%)
General disorders
Loss of Appetite	2/18 (11.1%)		1/18 (5.6%)
Fatigue	5/18 (27.8%)		4/18 (22.2%)
Fever/chills	4/18 (22.2%)		0/18 (0%)
Other conditions	12/18 (66.7%)		9/18 (50%)
Skin and subcutaneous tissue disorders
Skin rash	0/18 (0%)		1/18 (5.6%)

Limitations/Caveats

The primary limitation of this study was the small sample size.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.