Gut PermeabilityNCT07035964
Effects of Effera Human Lactoferrin at One Dose Compared to Placebo on Gut Permeability
A study testing human lactoferrin in people with Gut Permeability and Gut Health, run by Helaina Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the impact of 28-day supplementation with effera human lactoferrin, compared to a placebo control product on indicators of gut barrier health in males and females Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Permeability, Gut Health
- What is being tested?
- human lactoferrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2025to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or premenopausal female, 18 - 40 years of age, inclusive
- BMI ≥ 18.5 to < 40.0 kg/m2
- Abdominal adiposity defined by a waist circumference >40" in men or >35" in women measured at Visit 1.
- Reports at least mild GI symptoms from the 7d GI Symptom Questionnaire collected at visit
- 2. Mild GI symptoms will be defined as a combined weekly total score of gas/flatulence, abdominal distention/bloating, borborygmus/stomach rumbling, or burping symptoms ≥ 3.
- 5. Non-user or former user (daily use; cessation ≥ 12 months) of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months of visit 1, and has no plans to begin use during the study period.
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- 6. Non-habitual users (i.e., daily or almost daily) of marijuana or hemp products, including CBD/THC products, and willing to abstain from use throughout the study period (topical creams/lotions are allowed).
- 7. Willing to use personal smart phone with operating system (Android version 8.0 or newer; iOS version 15.5 or newer) capable of downloading the Cronometer app for diet records.
- 8. Willing to adhere to all study procedures, including lifestyle considerations ,and sign forms providing informed consent to participate in the study and authorization to release relevant protected health information to the Clinical Investigator.
Who cannot join
- Clinically important GI condition that would potentially interfere with the evaluation of the study product (e.g., inflammatory bowel disease, irritable bowel syndrome, Crohn's disease, celiac disease, history of surgery for weight loss, gastroparesis, and clinically significant lactose or gluten intolerance or other food or ingredient allergies).
- Recent (≤ 3 months of visit 1) endoscopy or colonoscopy preparation.
- Abnormal laboratory test results of clinical significance at visit 1, at the discretion of the Clinical Investigator. One re-test will be allowed on a separate day prior to visit 2, for participants with abnormal laboratory test results.
- Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at Visit 1. Stable use of hypertension medication is allowed (defined as no change in medication regimen within the 90 days prior to Visit 1).
- Uncontrolled and/or clinically important pulmonary (including uncontrolled asthma), cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), hepatic, renal, endocrine (including Type 1 and Type 2 diabetes mellitus), hematologic, immunologic, neurologic (such as Alzheimer's or Parkinson's disease), psychiatric (including depression and/or anxiety disorders) or biliary disorders. Conditions that are well-controlled or resolved will be assessed by the Clinical Investigator on a case-by-case basis.
- Unstable use (change in dose) of any prescription medications ≤ 90 d of visit 1, except for medications used PRN (e.g., asthma inhalers, non-drowsy seasonal allergy medications, etc.).
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- History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
- Major trauma or any surgical event within 3 months of visit 1.
- Currently scheduled, or planning to schedule, an elective surgical procedure during the study.
- Signs or symptoms of an active infection of clinical relevance within 5 days of visit 1. The visit may be rescheduled once all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 days prior to Visit 1. If an infection occurs during the study period, test visits will be rescheduled until signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 days prior to the scheduled study visits.
- Diagnosis of tuberculosis of hepatitis within 1 year prior to study.
- Extreme dietary habits (e.g., ketogenic, very high protein, very high fiber, vegan/vegetarian) at the discretion of the Clinical Investigator.
- Weight loss or gain >4.5 kg in the 3 months prior to visit 1.
- Currently or planning to be on a weight loss regimen during the study.
- Recent history (≤ 12 months visit 1) of alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 11⁄2 oz distilled spirits).
- Antibiotic use within 3 months of visit 1 and throughout the study period.
- Recent use of oral or injectable steroids, or topical or inhaled steroids (≥ 1500 μg/d), ≤ 90 dof visit 1.
- Regular use (≥ 3 days/week ≤ 1 month of visit 1) of anti-inflammatory medications (e.g., NSAIDS) and throughout the study period.
- Use of medications (over-the-counter or prescription) and/or dietary supplements known to influence GI function, including but not limited to: pre-, post-, and probiotic supplements, fiber supplements, laxatives, enemas, suppositories, H2 blockers, proton pump inhibitors, antacids, anti-diarrheal agents, anti-depressants, and/or anti-spasmodic within 2 weeks of visit 1 and throughout the study period.
- Recent use of dietary supplements containing bovine lactoferrin or iron in excess of the RDA (within 60 d of Visit 1). Standard multivitamin and mineral supplements are allowed.
- Exposure to any non-registered drug product within 1 month of visit 1 and throughout the study period.
- Pre-menopausal females with an irregular menstrual cycle (regular cycle defined as 21 to 35 days in length for the last 3 months prior to visit 1).
- Female who is diagnosed with Premenstrual Dysphoric Disorder (PMDD).
- Female who reports only experiencing GI symptoms around the time of menses.
- Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. Women who become pregnant during the study will be discontinued.
- Female who is unwilling to adhere to medically-recognized forms of birth control (e.g., hormonal and non-hormonal contraceptives, barrier methods, abstinence, etc).
- Female who is unwilling to wear a tampon during the collection of urine samples when these collections occur during the time of menstruation.
- Known sensitivity, intolerability, or allergy to any of the study products, study foods, or their excipients.
- Has a condition the Clinical Investigator believes would interfere with his ability to provide informed consent, and comply with the study protocol, which might confound the interpretation of the study results, or put the participant at undue risk.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Biofortis Inc
Addison, Illinois, 60101
Dr Antoo, MD, 630-617-200, biofortisresearch@mxns.com
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Parallel Study on the Effects of Effera Human Lactoferrin on Gastrointestinal Permeability
The purpose of this study is to evaluate the impact of 28-day supplementation with effera human lactoferrin, compared to a placebo control product on indicators of gut barrier health in males and females
Read the detailed description
Samples will be retained for possible analyses such lactoferrin absorption and immune biomarkers
- Conditions
- Gut Permeability, Gut Health
- Being tested
- human lactoferrin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human lactoferrinDietary supplement
Also called effera
effera human lactoferrin
PlaceboDietary supplement
Also called Control
Placebo Control
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplement: effera human lactoferrin | Experimental | Dietary supplement: effera human lactoferrin Receives: Dietary Supplement: human lactoferrin |
| Dietary Supplement: Placebo Control | Placebo comparator | Dietary Supplement: Placebo Control Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
lactulose to mannitol ratio
Change from baseline of lactulose to mannitol ratio
Measured: 0, 4 weeks
Secondary outcomes (1)
Markers of gut barrier function
Change from baseline in markers of gut barrier function (such as the change in 2-8 h urine LMR from baseline to day 28, change in 7d GI Symptom Questionnaire scores from baseline to day 28, change in Digestion-associated Quality of Life Questionnaire (DQLQ) score from baseline to day 28 and change in fasting plasma LBP concentrations from baseline to day 28)
Measured: 0, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start4 Jun 2025
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut PermeabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helaina Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biofortis Mérieux NutriSciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035964
- Sponsor's protocol ID
- BIO-2504
- Status last verified
- Jun 2025
- First submitted
- 6 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Parallel Study on the Effects of Effera Human Lactoferrin on Gastrointestinal Permeability
- ClinicalTrials.gov ID
- NCT07035964
- Acronym / sponsor ID
- BIO-2504
- Conditions
- Gut Permeability, Gut Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Helaina Inc.Industry (pharma, biotech, devices)
- Collaborators
- Biofortis Mérieux NutriSciences
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the impact of 28-day supplementation with effera human lactoferrin, compared to a placebo control product on indicators of gut barrier health in males and females
Detailed description
Samples will be retained for possible analyses such lactoferrin absorption and immune biomarkers
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement: effera human lactoferrin | Experimental | Dietary Supplement: human lactoferrinDietary supplement: effera human lactoferrin |
| Dietary Supplement: Placebo Control | Placebo comparator | Dietary Supplement: PlaceboDietary Supplement: Placebo Control |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male or premenopausal female, 18 - 40 years of age, inclusive
- BMI ≥ 18.5 to < 40.0 kg/m2
- Abdominal adiposity defined by a waist circumference >40" in men or >35" in women measured at Visit 1.
- Reports at least mild GI symptoms from the 7d GI Symptom Questionnaire collected at visit
- 2. Mild GI symptoms will be defined as a combined weekly total score of gas/flatulence, abdominal distention/bloating, borborygmus/stomach rumbling, or burping symptoms ≥ 3.
Key exclusion criteria (29 listed)
- Clinically important GI condition that would potentially interfere with the evaluation of the study product (e.g., inflammatory bowel disease, irritable bowel syndrome, Crohn's disease, celiac disease, history of surgery for weight loss, gastroparesis, and clinically significant lactose or gluten intolerance or other food or ingredient allergies).
- Recent (≤ 3 months of visit 1) endoscopy or colonoscopy preparation.
- Abnormal laboratory test results of clinical significance at visit 1, at the discretion of the Clinical Investigator. One re-test will be allowed on a separate day prior to visit 2, for participants with abnormal laboratory test results.
- Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at Visit 1. Stable use of hypertension medication is allowed (defined as no change in medication regimen within the 90 days prior to Visit 1).
- Uncontrolled and/or clinically important pulmonary (including uncontrolled asthma), cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), hepatic, renal, endocrine (including Type 1 and Type 2 diabetes mellitus), hematologic, immunologic, neurologic (such as Alzheimer's or Parkinson's disease), psychiatric (including depression and/or anxiety disorders) or biliary disorders. Conditions that are well-controlled or resolved will be assessed by the Clinical Investigator on a case-by-case basis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| human lactoferrinAlso: efferaeffera human lactoferrin | Dietary supplement | Dietary supplement: effera human lactoferrin |
| PlaceboAlso: ControlPlacebo Control | Dietary supplement | Dietary Supplement: Placebo Control |
Primary outcome
lactulose to mannitol ratio
Time frame: 0, 4 weeks
Change from baseline of lactulose to mannitol ratio
1 secondary outcome
Markers of gut barrier function
Time frame: 0, 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing human lactoferrin in people with Gut Permeability and Gut Health, run by Helaina Inc. 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 9 inclusion and 29 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: looking for participants now, as of the sponsor's last update on 25 Jun 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ross Peterson, Ph.D. (7204097993, ross@myhelaina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lactulose to mannitol ratio (time frame: 0, 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2025.