[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Helaina Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":5},"100633252","effera-dose-response-womens-health-100633252",false,"NCT07524270","Effera Dose Response: Women's Health","Dose-Response of Effera® Supplementation for Women's Health Outcomes","Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be eligible for participation:\n\n* Women, 18 - 40 years of age\n* No changes in hormonal contraception use in the past 6 months\n* Regular or mildly irregular cycles (24-45 days) for the past 3 months\n* 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)\n* 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\n* 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\n* 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.)\n* Generally healthy and free of diseases or disorders that impact functioning of the gastrointestinal system.\n* No recent or acute infection in the past 30 days and no chronic systemic illness\n* No psychiatric condition that, in the investigator's judgment, would impair consent capacity, protocol adherence, or valid completion of questionnaires.\n* If psychiatric medication is used: stable regimen for ≥3 months with no anticipated changes during the study\n* Body mass index (BMI) 18.5 to 32.5 kg\u002Fm2 (Inclusive)\n* Non-smoker\n* 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.\n* Willing and able to maintain consistent diet and physical activity habits\n* Willing and able to provide consent and comply with the protocol\n* Access to a smartphone, electronic, or personal computer with access to the internet to allow for completion of all online instruments and study reporting\n* Able to read and understand English at the 6th-grade level and sign the informed consent to participate in the study\n* Willing to use reliable contraception or maintain sexual abstinence during the study\n\nExclusion Criteria:\n\nParticipants will be excluded if any of the following apply:\n\n* Current or prior diagnosis from a licensed medical provider of Premenstrual Dysphoric Disorder (PMDD) or Premenstrual Syndrome (PMS) requiring ongoing medical or psychiatric treatment.\n* 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\n* Has any of the following medical conditions: bleeding disorders, active heart or cardiovascular disease, uncontrolled high blood pressure (≥ 140\u002F90 mmHg), renal or hepatic impairment\u002Fdisease, Type I or II diabetes, any neurologic disease or disorder that may impact cognition or mood, unstable thyroid disease, chronic inflammatory conditions, immune disorders (such as HIV\u002FAIDS), or any medical condition deemed exclusionary by the Principal Investigator (PI)\n* Acute illness or infection within the past 30 days\n* History of cancer (except localized skin cancer without metastases) within 5 years prior to screening.\n* 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\n* Habitual use of anti-inflammatory medications for 30 days prior to providing consent\n* Current or past diagnosis of bipolar I\u002FII disorder, schizophrenia spectrum or other psychotic disorder; psychiatric hospitalization, suicidal ideation, attempt, or self-harm behavior in the past 12 months\n* Initiation, discontinuation, or dose change of any psychotropic medication within the past 3 months, including antidepressants, anxiolytics, antipsychotics, mood stabilizers, stimulants, or sedative-hypnotics\n* Subject has an allergy to any ingredients in the study product\n* Subject has a history of drug or alcohol abuse in the past 12 months\n* Excessive alcohol intake defined as greater than 7 drinks\u002Fweek or binge episodes\n* 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.\n* Participating in or has participated in another research study within 30 days prior to the screening visit that could confound outcomes\n* Currently pregnant or lactating\n* Currently in prison, custody, or otherwise considered a ward of the state preventing their ability to free participate",true,"FEMALE","18 Years","40 Years",{"count":21,"type":22},160,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.\n\nThe main questions it aims to answer are:\n\nDoes effera® reduce the severity of menstrual symptoms?\n\nDoes effera® improve mood, gastrointestinal symptoms, and overall well-being?\n\nResearchers 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.\n\nParticipants will:\n\nTake the assigned supplement (effera® or placebo) daily for 12 weeks\n\nComplete online questionnaires about menstrual symptoms, mood, and health\n\nOptionally share sleep and activity data from a wearable device",[28,29],"Womens Health","Menstrual Symptoms",[31,32,33,34,35,36,37],"Lactoferrin","Menstrual health","Dysmenorrhea","Effera","Gastrointestinal symptoms","Mood","Quality of life","RECRUITING","2026-04-06",{"date":41,"type":42},"2026-04-13","ACTUAL",{"date":44,"type":22},"2026-04",{"date":46,"type":22},"2026-12",{"name":48,"class":49},"Helaina Inc.","INDUSTRY",{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":16,"sex":57,"minAge":18,"maxAge":19,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100595708","effects-of-effera-human-lactoferrin-at-one-dose-compared-to-placebo-on-gut-permeability-100595708","NCT07035964","Effects of Effera Human Lactoferrin at One Dose Compared to Placebo on Gut Permeability","Randomized, Double-Blind, Placebo-Controlled, Parallel Study on the Effects of Effera Human Lactoferrin on Gastrointestinal Permeability","Inclusion Criteria:\n\n1. Male or premenopausal female, 18 - 40 years of age, inclusive\n2. BMI ≥ 18.5 to \\\u003C 40.0 kg\u002Fm2\n3. Abdominal adiposity defined by a waist circumference \\>40\" in men or \\>35\" in women measured at Visit 1.\n4. Reports at least mild GI symptoms from the 7d GI Symptom Questionnaire collected at visit\n\n2\\. Mild GI symptoms will be defined as a combined weekly total score of gas\u002Fflatulence, abdominal distention\u002Fbloating, borborygmus\u002Fstomach rumbling, or burping symptoms ≥ 3.\n\n5\\. 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.\n\n6\\. Non-habitual users (i.e., daily or almost daily) of marijuana or hemp products, including CBD\u002FTHC products, and willing to abstain from use throughout the study period (topical creams\u002Flotions are allowed).\n\n7\\. 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.\n\n8\\. 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.\n\nExclusion Criteria:\n\n1. 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).\n2. Recent (≤ 3 months of visit 1) endoscopy or colonoscopy preparation.\n3. 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.\n4. 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).\n5. Uncontrolled and\u002For 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\u002For 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.\n6. 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.).\n7. History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.\n8. Major trauma or any surgical event within 3 months of visit 1.\n9. Currently scheduled, or planning to schedule, an elective surgical procedure during the study.\n10. 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.\n11. Diagnosis of tuberculosis of hepatitis within 1 year prior to study.\n12. Extreme dietary habits (e.g., ketogenic, very high protein, very high fiber, vegan\u002Fvegetarian) at the discretion of the Clinical Investigator.\n13. Weight loss or gain \\>4.5 kg in the 3 months prior to visit 1.\n14. Currently or planning to be on a weight loss regimen during the study.\n15. 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).\n16. Antibiotic use within 3 months of visit 1 and throughout the study period.\n17. Recent use of oral or injectable steroids, or topical or inhaled steroids (≥ 1500 μg\u002Fd), ≤ 90 dof visit 1.\n18. Regular use (≥ 3 days\u002Fweek ≤ 1 month of visit 1) of anti-inflammatory medications (e.g., NSAIDS) and throughout the study period.\n19. Use of medications (over-the-counter or prescription) and\u002For 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\u002For anti-spasmodic within 2 weeks of visit 1 and throughout the study period.\n20. 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.\n21. Exposure to any non-registered drug product within 1 month of visit 1 and throughout the study period.\n22. 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).\n23. Female who is diagnosed with Premenstrual Dysphoric Disorder (PMDD).\n24. Female who reports only experiencing GI symptoms around the time of menses.\n25. 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.\n26. Female who is unwilling to adhere to medically-recognized forms of birth control (e.g., hormonal and non-hormonal contraceptives, barrier methods, abstinence, etc).\n27. Female who is unwilling to wear a tampon during the collection of urine samples when these collections occur during the time of menstruation.\n28. Known sensitivity, intolerability, or allergy to any of the study products, study foods, or their excipients.\n29. 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.","ALL",{"count":59,"type":22},46,[25],"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",[63,64],"Gut Permeability","Gut Health","2025-06-16",{"date":67,"type":42},"2025-06-25",{"date":69,"type":42},"2025-06-04",{"date":71,"type":22},"2025-08-30",{"name":48,"class":49},1,""]