Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT04005456
Eligibility Criteria:
General Inclusion Criteria for 'N of 1' Tent:
* male or female
* ages 18-80, inclusive
* willing to give written informed consent to participate in the study
General Exclusion Criteria for 'M of 1' Tent:
* Medical History and Concurrent Diseases:
* A serious, unstable illness including cardiac, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic, immunologic/rheumatological, or hematologic disease.
* Known infection with HIV, TB or Hepatitis B or C.
* Inability to comply with study and/or follow-up visits.
* Any concurrent condition (including clinically significant abnormalities in medical history, physical examination or laboratory evaluations) which, in the opinion of the PI, would preclude safe participation in this study or interfere with compliance.
* Any sound medical, psychiatric and/or social reason which, in the opinion of the PI, would preclude safe participation in this study or interfere with compliance.
The following describes specific inclusion and/or exclusion criteria applicable to individual study arms.
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Wellness Umbrella:
Specific Exclusion Criteria:
* MOS SF-36 QN general score \< 60
Elevated Homocysteine Bucket:
Specific Inclusion Criteria:
* Elevated Homocysteine Level ≥ 10.4 µmol/L
Specific Exclusion Criteria:
* MOS SF-36 QN general score \< 60
Dental Health Umbrella:
Specific Inclusion Criteria:
* Participants with extensive gingivitis/periodontitis/Caries/Painful teeth/Fractured Teeth. Identification of any of the following on physical exam: gingivitis, receding gumlines, periodontitis, fractured teeth, multiple unrestored caries. Identification on history of bleeding gums, bleeding while flossing, bleeding when brushing, chronic sores in the mouth, painful teeth, pain when biting on aluminum foil.
Neurological Health Umbrella:
Specific Inclusion Criteria:
* Elevated score on any subscale of Depression Anxiety Stress Scale (DASS) QN; and/or a score demonstrating mild or moderate depression or anxiety on Beck Depression Score and Beck Anxiety Score; and/or a MOS SF-36 subscale Emotional Role Functioning or Mental Health \< 50; and/or PROMIS Cognitive Function QN score \< 50.
Autoimmune and Inflammatory Conditions Umbrella:
Specific Inclusion Criteria:
* Symptoms, signs, laboratory biomarkers or diagnosis consistent with the features/diagnosis of an Autoimmune/Inflammatory Condition (excluding metabolic disorders/atherosclerosis) and ill-defined conditions characterized by symptomatic fatigue/myalgias.
Elevated ANA Bucket:
Specific Inclusion Criteria:
* General Inclusion Criteria for Autoimmune and Inflammatory Conditions Umbrella
* Elevated ANA Level \> 1:40 titer (A specified sub-group for analysis will be all with two baseline elevated ANA Level \> 1:40 titer.)
Specific Exclusion Criteria:
* Symptoms, signs, laboratory biomarkers (excluding ANA) or diagnosis consistent with the features/diagnosis of an Autoimmune/Inflammatory Condition (excluding metabolic disorders/atherosclerosis)
Autoimmune Conditions Bucket:
Specific Inclusion Criteria:
* Established Diagnosis of an autoimmune condition (Systemic Lupus Erythematosus, Rheumatoid Arthritis, Inflammatory Bowel Disease and Hashimoto's Thyroiditis) with ANA level \>1:80 titer, rheumatoid factor (RF) ≥ 14 IU/ml, fecal calprotectin ≥ 50 mcg/g and thyroid autoantibody levels specifically thyroglobulin antibodies ≥ 115 IU/ml and/or thyroid peroxidase antibodies ≥ 35 IU/ml.
Symptomatic Fatigue and Myalgia Bucket:
Specific Inclusion Criteria:
* Two of the following five features have been generally present for at least 3 months:
* Widespread bodily pain (pain in 3 of 5 regions (Left upper, right upper, left lower, right lower, axial) with and without symptomatic trigger points
* Generalized fatigue
* Sleep disturbances including awakening unrefreshed
* Cognitive (memory or thought) problems
* Post-exertional malaise
Gastrointestinal Health Umbrella:
Specific Inclusion Criteria:
* Symptoms, signs, laboratory biomarkers or diagnosis consistent with the features/diagnosis of Irritable Bowel Syndrome and other GI symptomatology (excluding Inflammatory Bowel Disease) as well as physiological challenges with healthy detoxification
IBS Bucket:
Specific Inclusion Criteria:
* Symptoms, signs, laboratory biomarkers or diagnosis consistent with the features/diagnosis of Irritable Bowel Syndrome and other GI symptomatology (excluding Inflammatory Bowel Disease)
Detoxification Bucket:
Specific Inclusion Criteria:
* Symptoms, signs, laboratory biomarkers or diagnosis consistent physiological challenges with healthy detoxification
Wellness Detoxification Bucket:
Specific Inclusion Criteria:
* Symptoms, signs, laboratory biomarkers or diagnosis consistent physiological challenges with healthy detoxification
Metabolic Health Umbrella:
Specific Inclusion Criteria:
* BMI\>= 18.5 and \<40
Consequences of Metabolic Function/Dysfunction Bucket - Crossover Design:
Specific Inclusion Criteria:
* BMI\>= 18.5 and \<40
* Metabolic Dysfunction is defined as having at least two of the following: Glucose ≥ 100 mg/dl; Homeostatic Model of Assessment for Insulin Resistance (HOMA-IR) (Glucose \[mg/dl\]Insulin \[µiu/L)/405), score ≥ 2.0; HbA1c ≥ 5.7%; Triglycerides ≥ 100 mg/dl; Low Density Lipoprotein Particle Number (LDLp) \>1000, lipoprotein (a) (lp(a)) \> 30 mg/dl ; HDL (women) ≤ 50 ng/ml; HDL (men) ≤ 40 ng/ml; and blood pressure ≥ 135/85 mm Hg.
Specific Exclusion Criteria:
* Any of the following: Fasting Blood Glucose ≥ 125mg/dl; HbA1c ≥ 6.5% and Blood Pressure ≥ 165/95 mm Hg.
Consequences of Metabolic Function/Dysfunction Bucket - Randomization/Inclusion Design:
Specific Inclusion Criteria:
* BMI\>= 18.5 and \<40
* Metabolic Dysfunction is defined as having at least two of the following: Glucose ≥ 100 mg/dl; Homeostatic Model of Assessment for Insulin Resistance (HOMA-IR) (Glucose \[mg/dl\]Insulin \[µiu/L)/405), score ≥ 2.0; HbA1c ≥ 5.7%; Triglycerides ≥ 100 mg/dl; Low Density Lipoprotein Particle Number (LDLp) \>1000, lipoprotein (a) (lp(a)) \> 30 mg/dl; HDL (women) ≤ 50 ng/ml; HDL (men) ≤ 40 ng/ml; and blood pressure ≥ 135/85 mm Hg
Specific Exclusion Criteria:
* Any of the following: Fasting Blood Glucose ≥ 125mg/dl; HbA1c ≥ 6.5% and Blood Pressure ≥ 165/95 mm Hg.
Reproductive Health Umbrella:
Specific Inclusion Criteria:
* Applicable to female Participants: a clinical diagnosis of fibrocystic breast and/or increased risk for Breast cancer, polycystic ovary syndrome, endometriosis, premenstrual syndrome, peri-menopause and menopausal conditions.
* Applicable to male Participants: a diagnosis of testosterone deficiency and andropause/late onset hypogonadism or prostate health concerns.
Perimenopausal and Menopausal Transitions Bucket:
Specific Inclusion Criteria:
* Female with signs/symptoms consistent with a clinical diagnosis of peri-menopause and menopausal conditions.
Premenstrual Syndrome Bucket:
Specific Inclusion Criteria:
* Female with a diagnosis of premenstrual syndrome and/or signs/symptoms/biomarkers consistent with estrogen/progesterone imbalances.
PCOS Bucket:
Specific Inclusion Criteria:
* Female with signs/symptoms/biomarkers consistent with a clinical diagnosis of PCOS.
Andropause/Late Onset Hypogonadism Bucket:
Specific Inclusion Criteria:
* Male with signs/symptoms/biomarkers consistent with a clinical diagnosis of Andropause/Late Onset Hypogonadism.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04005456
Study Brief:
Protocol Section:
NCT04005456