Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Change in concentration of at-home (direct-to-consumer) specimen assays either saliva, blood or stool |
Mean difference in specimen assays as surrogates and/or markers for health outcomes. (Optional; among consented participants only) Potentially include saliva (IgG, cytokines, DHEA-S, Estradiol, Progesterone, Testosterone, Cortisol, Melatonin, CRP) blood (1 drop) (Cortisol, Homocysteine, Ferritin, TSH, HbA1c, Insulin, Vitamin D, DHEA-S, Testosterone, Estradiol, FSH, Total Cholesterol, HDL, LDL, Triglycerides, ApoA1, ApoB). Stool (microbial diversity). Test are optional. Unit of measure will vary based on test selected |
6 weeks |
|
Primary |
Change in GI (Gastrointestinal) Health (1) |
Mean difference in Gastrointestinal Health scores as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Belly Pain 5A (scale 2-25; with higher scores corresponding to more severe abdominal pain) |
6 weeks |
|
Primary |
Change in GI (Gastrointestinal) Health (2) |
Mean difference in Gastrointestinal Health scores as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Gas and Bloating 13A (scale 2-60; with higher scores corresponding to more severe gas/bloating) |
6 weeks |
|
Primary |
Change in GI (Gastrointestinal) Health (3) |
Mean difference in GI Health scores as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Constipation 9A (scale 5-45; with higher scores corresponding to more severe constipation) |
6 weeks |
|
Primary |
Change in GI (Gastrointestinal) Health (4) |
Mean difference in GI Health scores as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Diarrhea 6A (scale 2-30; with higher scores corresponding to more severe diarrhea) |
6 weeks |
|
Primary |
Change in GI (Gastrointestinal) Health (5) |
Mean difference in GI Health scores as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Gastroesophageal Reflux 13A (scale 8-64; with higher scores corresponding to more severe reflux) |
6 weeks |
|
Primary |
Change in GI (Gastrointestinal) Health (6) |
Mean difference in GI Health scores as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Nausea and Vomiting 4A (scale 3-20; with higher scores corresponding to more severe nausea and vomiting) |
6 weeks |
|
Secondary |
Change in feelings of anxiety |
Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety) |
6 weeks |
|
Secondary |
Change in GI-related Quality of Life (QOL) |
Mean difference in GI-related QOL as assessed by Digestion-associated QOL Questionnaire (DGLQ) (scale 0%-100%; with higher scores corresponding to worse GI-related QOL) |
6 weeks |
|
Secondary |
Change in mood (emotional distress-depression) |
Mean difference in emotional distress score as assessed by PROMIS Emotional Distress- Depression 4A (scale 4-20; with higher scores corresponding to greater levels of emotional distress) |
6 weeks |
|
Secondary |
Minimal clinically important difference (MCID) in GI Health (1) |
Likelihood of experiencing minimal clinically important difference in GI Health score as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Belly Pain 5A (scale 2-25; with higher scores corresponding to more severe abdominal pain) |
6 weeks |
|
Secondary |
Minimal clinically important difference (MCID) in GI Health (2) |
Likelihood of experiencing minimal clinically important difference in GI Health score as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Gas and Bloating 13A (scale 2-60; with higher scores corresponding to more severe gas/bloating) |
6 weeks |
|
Secondary |
Minimal clinically important difference (MCID) in GI Health (3) |
Likelihood of experiencing minimal clinically important difference in GI Health score as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Constipation 9A (scale 5-45; with higher scores corresponding to more severe constipation) |
6 weeks |
|
Secondary |
Minimal clinically important difference (MCID) in GI Health (4) |
Likelihood of experiencing minimal clinically important difference in GI Health score as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Diarrhea 6A (scale 2-30; with higher scores corresponding to more severe diarrhea) |
6 weeks |
|
Secondary |
Minimal clinically important difference (MCID) in GI Health (5) |
Likelihood of experiencing minimal clinically important difference in GI Health score as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Gastroesophageal Reflux 13A (scale 8-64; with higher scores corresponding to more severe reflux) |
6 weeks |
|
Secondary |
Minimal clinically important difference (MCID) in GI Health (6) |
Likelihood of experiencing minimal clinically important difference in GI Health score as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Nausea and Vomiting 4A (scale 3-20; with higher scores corresponding to more severe nausea and vomiting) |
6 weeks |
|
Secondary |
Minimal clinically important difference (MCID) in feelings of anxiety |
Likelihood of experiencing minimal clinically important difference in feelings of anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety) |
6 weeks |
|
Secondary |
Minimal clinically important difference (MCID) in GI-related QOL |
Likelihood of experiencing minimal clinically important difference in GI-related QOL score as assessed by Digestion-associated QOL Questionnaire (DGLQ) (scale 0%-100%; with higher scores corresponding to worse GI-related QOL) |
6 weeks |
|
Secondary |
Minimal clinically important difference (MCID) in mood (emotional distress-depression) |
Likelihood of experiencing minimal clinically important difference in mood score as assessed by PROMIS Emotional Distress- Depression 4A (scale 4-20; with higher scores corresponding to greater levels of emotional distress) |
6 weeks |
|