Effera Dose Response: Women's Health

NCT07524270 | Recruiting

• 1 other identifier: HEL-001
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to learn if a human equivalent lactoferrin supplement (effera®) can improve menstrual symptoms, mood, and quality of life in healthy women aged 18-40. The main questions it aims to answer are: Does effera® reduce the severity of menstrual symptoms? Does effera® improve mood, gastrointestinal symptoms, and overall well-being? Researchers will compare three different doses of effera® to a placebo (a look-alike supplement with no active ingredient) to see if the supplement improves these outcomes. Participants will: Take the assigned supplement (effera® or placebo) daily for 12 weeks Complete online questionnaires about menstrual symptoms, mood, and health Optionally share sleep and activity data from a wearable device

Conditions

Womens Health; Menstrual Symptoms

Keywords

Lactoferrin; Menstrual health; Dysmenorrhea; Effera; Gastrointestinal symptoms; Mood; Quality of life

Outcome Measures

Primary Outcomes (1)

• Change in menstrual symptoms (MSQ-24 score)

  Menstrual symptoms will be assessed using the validated 24-item Menstrual Symptoms Questionnaire (MSQ-24), which measures the severity and frequency of physical, emotional, and behavioral symptoms associated with the menstrual cycle. Each item will be presented as a 5-level Likert scale (1=Never; 2=Rarely; 3=Sometimes; 4=Often; 5=Always). Higher scores indicate greater symptom burden.

  Baseline, Week 4, Week 8, and Week 12

Secondary Outcomes (4)

• Change in global health (PROMIS Global Health-10)

  Baseline, Week 4, Week 8, and Week 12

• Change in psychological distress (PHQ-4)

  Weekly from Baseline through Week 12

• Change in gastrointestinal symptoms (PROMIS-GI Short Form)

  Baseline, Week 4, Week 8, and Week 12

• Change in menstrual cycle-specific symptoms

  Baseline and monthly during the study (Weeks 4, 8, and 12)

Other Outcomes (1)

• Sleep and physical activity metrics (wearable devices)

  Continuously collected throughout the 12-week study period

Study Arms (4)

Arm 1: Placebo Comparator

PLACEBO COMPARATOR

Participants receive a matched placebo supplement daily for 12 weeks.

Other: Placebo

Arm 2: Effera® 100 mg

ACTIVE COMPARATOR

Participants receive 100 mg of effera® (human equivalent lactoferrin) once daily for 12 weeks.

Dietary Supplement: Effera® (human equivalent lactoferrin)

Arm 3: Effera® 200 mg (Split Dose)

ACTIVE COMPARATOR

Participants receive 200 mg of effera® daily, administered as two 100 mg doses, for 12 weeks

Dietary Supplement: Effera® (human equivalent lactoferrin)

Arm 4: Effera® 300 mg

ACTIVE COMPARATOR

Participants receive 300 mg of effera® once daily for 12 weeks.

Dietary Supplement: Effera® (human equivalent lactoferrin)

Interventions

Placebo OTHER

Matched placebo supplement identical in appearance and packaging to the active intervention, administered orally once daily for 12 weeks.

Arm 1: Placebo Comparator

Effera® (human equivalent lactoferrin) DIETARY_SUPPLEMENT

Effera® is a human equivalent lactoferrin supplement administered orally once daily at varying doses (100 mg, 200 mg, or 300 mg) depending on randomized assignment. Lactoferrin is a naturally occurring protein involved in immune regulation, iron metabolism, and inflammation.

Arm 2: Effera® 100 mg; Arm 3: Effera® 200 mg (Split Dose); Arm 4: Effera® 300 mg

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must meet all of the following criteria to be eligible for participation:
• Women, 18 - 40 years of age
• No changes in hormonal contraception use in the past 6 months
• Regular or mildly irregular cycles (24-45 days) for the past 3 months
• In the majority (\>3) of menstrual cycles over the past 6 months, experience menstrual cramps on a pain scale of at least 4 out of 10 (1=no pain at all and 10 = worst pain ever experienced)
• In the majority (\>3) of menstrual cycles over the past 6 months, experience pain so significant that it requires over-the-counter pain medication for at least 2 days (on average) per period
• In the majority (\>3) of menstrual cycles over the past 6 months, experience at least one day per cycle where menstrual symptoms either interfere with work or school performance, limit normal daily activities or exercise, or lead to staying home, leaving early, or modifying plans
• Reports noticeable mood or physical changes in the 5-7 days before menses in most cycles (irritability, mood, bloating, breast tenderness, cravings, sleep changes, etc.)
• Generally healthy and free of diseases or disorders that impact functioning of the gastrointestinal system.
• No recent or acute infection in the past 30 days and no chronic systemic illness
• No psychiatric condition that, in the investigator's judgment, would impair consent capacity, protocol adherence, or valid completion of questionnaires.
• If psychiatric medication is used: stable regimen for ≥3 months with no anticipated changes during the study
• Body mass index (BMI) 18.5 to 32.5 kg/m2 (Inclusive)
• Non-smoker
• Agrees to not use any new vitamin, mineral, or dietary supplement product until after study completion and to not take any vitamins, minerals or dietary supplements 24 hours prior to the exercise test visits.

You may not qualify if:

• Participants will be excluded if any of the following apply:
• Current or prior diagnosis from a licensed medical provider of Premenstrual Dysphoric Disorder (PMDD) or Premenstrual Syndrome (PMS) requiring ongoing medical or psychiatric treatment.
• History of any food allergies or intolerances that could impact digestive outcomes and history of irritable bowel syndrome, inflammatory bowel disease (Crohn's, ulcerative colitis, celiac), gastroparesis, chronic constipation or diarrhea requiring medication, or GI surgery
• Acute illness or infection within the past 30 days
• History of cancer (except localized skin cancer without metastases) within 5 years prior to screening.
• Recently started taking (within the past 90 days or has had their dosage adjusted in the past 90 days) antihypertensives, hypoglycemic medications, GLP1 agonists of any class or type, stimulatory asthma medications, or any other prescription or over-the-counter medication that confound the outcomes measured in this study
• Habitual use of anti-inflammatory medications for 30 days prior to providing consent
• Current or past diagnosis of bipolar I/II disorder, schizophrenia spectrum or other psychotic disorder; psychiatric hospitalization, suicidal ideation, attempt, or self-harm behavior in the past 12 months
• Initiation, discontinuation, or dose change of any psychotropic medication within the past 3 months, including antidepressants, anxiolytics, antipsychotics, mood stabilizers, stimulants, or sedative-hypnotics
• Subject has an allergy to any ingredients in the study product
• Subject has a history of drug or alcohol abuse in the past 12 months
• Excessive alcohol intake defined as greater than 7 drinks/week or binge episodes
• Any condition or abnormality that in the expert opinion of the PI, participation in the study would compromise the safety of the subject or the quality of the study data.
• Participating in or has participated in another research study within 30 days prior to the screening visit that could confound outcomes
• Currently pregnant or lactating

Sponsors & Collaborators

• Helaina Inc.: lead

Study Sites (2)

Alethios

San Francisco, California, 94104, United States

RECRUITING

Alethios, Inc.

San Francisco, California, 94109, United States

NOT YET RECRUITING

Related Publications (4)

• Peterson RD, van der Made J, Kaplan N, Donovan SM, Wang M, Dilger RN, Clark AJ. Effects of human lactoferrin (effera) at two doses versus bovine lactoferrin on the adult gut microbiome and fecal short-chain fatty acids: A randomized, double-blind trial. medRxiv preprint. DOI: https://doi.org/10.64898/2025.12.31.25343278.

  BACKGROUND

• Peterson RD, Guarneiri LL, Adams CG, Wilcox ML, Clark AJ, Rudemiller NP, Maki KC, Malinczak CA. A Randomized, Double-Blind, Controlled Trial to Assess the Effects of Lactoferrin at Two Doses vs. Active Control on Immunological and Safety Parameters in Healthy Adults. Int J Toxicol. 2025 Jan-Feb;44(1):12-28. doi: 10.1177/10915818241293723. Epub 2024 Oct 28.

  PMID: 39465888 BACKGROUND

• Ueno HM, Yoshise RE, Sugino T, Kajimoto O, Kobayashi T. Effects of a Bovine Lactoferrin Formulation from Cow's Milk on Menstrual Distress in Volunteers: A Randomized, Crossover Study. Int J Mol Sci. 2016 May 31;17(6):845. doi: 10.3390/ijms17060845.

  PMID: 27258249 BACKGROUND

• Kowalczyk P, Kaczynska K, Kleczkowska P, Bukowska-Osko I, Kramkowski K, Sulejczak D. The Lactoferrin Phenomenon-A Miracle Molecule. Molecules. 2022 May 4;27(9):2941. doi: 10.3390/molecules27092941.

  PMID: 35566292 BACKGROUND

Related Links

• Eligibility screening survey for this decentralized trial

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Chad Kerksick, PhD

CONTACT

(650) 206-8006; chad.kerksick@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding and randomization will be facilitated through the Alethios platform.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized assigment, double-blind administration, placebo-controlled

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: April 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (2)