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InflammationPhase 2ELCIENCT02968992

Effects of rhLactoferrin on Chronic Inflammation in the Elderly

A Phase 2 study testing rhLactoferrin in people with Inflammation and Cognitive Deterioration, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Inflammation, Cognitive Deterioration
What is being tested?
rhLactoferrin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteUnited States
Study dates
14 Aug 2017to 25 Feb 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Jeremy D. Walston

    Baltimore, Maryland, 21224

Other trials in United States

About this study

Official title: Effects of Lactoferrin on Chronic Inflammation in the Elderly

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).

Read the 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

Being tested
rhLactoferrin, Placebo
Medical subject headings
Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rhLactoferrinDrug

    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.

  • PlaceboOther

    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.

Study groups in NCT02968992
Study groupRoleWhat they receive
rhLactoferrinExperimentalrH 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.
Receives: Drug: rhLactoferrin
PlaceboPlacebo comparatorMatching placebo capsule will be provided by Ventria Biosciences and six capsules twice a day will be provided to the subjects in this arm.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Effect of Rhlactoferrin on Serum Levels of Interleukin-6 (IL-6)

    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

    Measured: Baseline and 6 months

  2. The Effect of Rhlactoferrin on Serum Levels of Tumor Necrosis Factor Alpha Receptor 1 (TNFR1)

    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

    Measured: From baseline to 6 months

Secondary outcomes (6)

  1. Attenuating Cognitive Decline as Measured by the Digital Symbol Substitution Test

    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.

    Measured: At 6 months

  2. Attenuating Cognitive Decline as Measured by the Trail Making Test A and B.

    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.

    Measured: At 6 months

  3. Physical Mobility as Measured by 4 Meter Walk Test

    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.

    Measured: At 6 months

  4. Physical Mobility as Measured by 6 Minute Walk Test

    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.

    Measured: At 6 months

  5. Tolerability of Oral rhLactoferrin as Assessed by Patient Diary of Total Number of Side Effects

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

    Measured: From baseline through 6 months.

  6. Physical Strength as Measured by Grip Strength

    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.

    Measured: At 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2016 (estimated)
  2. Study start14 Aug 2017
  3. Primary completion25 Feb 2019
  4. Study completion25 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02968992
Sponsor's protocol ID
IRB00094982
Other IDs
R21AG053681-01
Acronym
ELCIE
Status last verified
Sep 2023
First submitted
15 Nov 2016
Last updated
3 Oct 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rhLactoferrin in people with Inflammation and Cognitive Deterioration, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Effect of Rhlactoferrin on Serum Levels of Interleukin-6 (IL-6) (time frame: Baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02968992.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.

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