A | B | C | |
PARTICIPANT REGISTRATION FOR (ADD STUDY NAME HERE) | |||
Participant Name | (First Name) | (Last Name) | |
Participant Study Registration Number: | |||
Study enrollment date (DD-MMM-YYYY): | |||
Local Medical Record Number: | |||
Birthdate (DD-MMM-YYYY): | |||
Sex assigned at birth: | □ Male | □ Female | |
Name of Site PI: | |||
Name of Research Staff: | |||
Name of Physician Performing Endoscopy: | |||
Inclusion Criteria | |||
If the response to any of the following questions is “No” it is likely that the subject is NOT eligible for participation in this study, please discuss with the site-PI. | |||
Is the participant less than 6 years old? | □ Yes | □ No | |
Will the participant undergo an upper or lower GI endoscopy? | □ Yes | □ No | |
Is it possible to obtain appropriate consent? "(i.e., child is >10 kg or both parents available for consent) " | □ Yes | □ No | |
Exclusion Criteria | |||
If the response to any of the following questions is “Yes” it is likely that the subject is NOT eligible for participation in this study, please discuss with the site-PI. | □ Yes | □ No | |
Does the participant have known coagulopathy, thrombocytopenia (<150K platelets), or a bleeding disorder? | □ Yes | □ No | |
Does the participant have a known connective tissue disorder | □ Yes | □ No | |
Are there any other conditions that would make the participant ineligible for this study? | □ Yes | □ No | |
If yes, please describe briefly: | |||
Study Consent Procedures | |||
Was consent obtained? | □ Yes | □ No | |
Date consent obtained (DD-MMM-YYYY): | |||
Who signed the consent? | □ Subject | □ Legal Guardian | |
□ Mother | □ Other: ____________ | ||
□ Father | |||
Initials of Research Staff who obtained consent: | |||
Comments from registration process: |
A | B | C | D | |
PARTICIPANT’S CLINICAL HISTORY | ||||
Reason for endoscopy: | □ Foreign Body Removal | □ Diarrhea | □ Failure to thrive | |
□ Dysphagia | □ Constipation | □ Abdominal Pain | ||
□ Reflux | □ Nausea/vomiting | □ Routine Clinical Care | ||
□ GI bleeding "(e.g., hematemesis, melena)" | □ Aspiration | □ Other: ____________ | ||
Anthropometrics | ||||
Current height or length (cm) | Date measured: | |||
Current weight (kg) | Date measured: | |||
Are growth records available prior to study? | □ Yes | □ No | ||
Laboratory | ||||
Complete Blood Count (CBC) | □ Yes | □ No | (if data is available) | |
If yes, date of CBC (DD-MMM-YYYY): | ||||
WBC (K cells/µL) | ||||
Hemoglobin (g/dL) | ||||
Hematocrit (%) | ||||
Platelets (K cells/µL) | ||||
Neutrophils (K cells/µL) | ||||
Lymphocytes (K cells/µL) | ||||
Eosinophils (K cells/µL) | ||||
Liver and Kidney Panel | □ Yes | □ No | (if data is available) | |
If yes, date of labs (DD-MMM-YYYY): | ||||
Total Bilirubin (mg/dL) | ||||
Direct Bilirubin (mg/dL) | ||||
Albumin (g/dL) | ||||
Alkaline Phosphate (U/L) | ||||
Aspartate transaminase (U/L) | ||||
Alanine transaminase (U/L) | ||||
Blood urea nitrogen (mg/dL) | ||||
Creatinine (mg/dL) | ||||
Other labs | ||||
Erythrocyte sedimentaion rate (mm/hr) | Date measured: | |||
C-reactive protein (mg/dL) | Date measured: | |||
Iron, plasma (mcg/dL) | Date measured: | |||
Total iron binding capacity (mcg/dL) | Date measured: | |||
Urea (mm/L) | Date measured: | |||
Urine sodium (mEq/L) | Date measured: | |||
Gamma-glutamyl Transferase (U/L) | Date measured: | |||
Ferritin (ng/mL) | Date measured: | |||
Stool Studies | ||||
CliniTest-reducing substance (during feeding) | □ Positive | □ Negative | Date measured: | |
Fecal Elastase (µg/g) | Date measured: | |||
Alpha1-Antitrypsin (mg/g) | Date measured: | |||
Stool pH (during feeding) | Date measured: | |||
Calprotectin (µg/mg) | Date measured: | |||
Lactoferrin (µg/ml) | Date measured: | |||
Stool Electrolytes | □ Yes | □ No | (if data is available) | |
If yes, date of labs (DD-MMM-YYYY): | ||||
Sodium (mmol/L) | ||||
Potassium (mmol/L) | ||||
Chlorine (mmol/L) | ||||
Bicarbonate (mEq/L) | ||||
Vitamin Deficiency | ||||
Vitamin A | □ Yes | □ No | □ Unknown | |
If yes, describe - provide lab value & range if present | ||||
Vitamin D | □ Yes | □ No | □ Unknown | |
If yes, describe - provide lab value & range if present | ||||
Vitamin E | □ Yes | □ No | □ Unknown | |
If yes, describe - provide lab value & range if present | ||||
Vitamin K | □ Yes | □ No | □ Unknown | |
If yes, describe - provide lab value & range if present | ||||
Gastroenterology Procedural History | □ Yes | □ No | □ Unknown | |
If yes, specify | □ Yes | □ No | Date measured: | |
If abnormal, select all locations that apply | □ Esophagus | |||
□ Stomach | ||||
□ Duodenum | ||||
□ Colon | ||||
□ Ileum |
A | B | |
Select all identities that apply, if there are additional identities not described below, please self-describe using Other. | ||
Race and/or Ethnicity:(Select all that apply) | □ Native American/Alaska Native | |
□ Black or African-American | ||
□ Middle Eastern/North African | ||
□ East Asian (e.g. Chinese, Japanese, Korean) | ||
□ Southeast Asian (e.g. Vietnamese, Filipino) | ||
□ South Asian (e.g. Indian, Pakistani) | ||
□ White | ||
□ Native Hawaiian or Other Pacific Islander | ||
□ Hispanic or Latino | ||
□ Not aligned with above categories: ___________________ (e.g., Ashkenazi Jewish, French Canadian, Afro-Caribbean, etc.) |
A | B | C | |
CHILD’S BIRTH HISTORY | |||
Country of birth? | |||
Estimated date of arrival in present country? (DD-MMM-YYYY): | □ Unknown or Does not apply | ||
Gestational age (weeks): | □ Unknown | ||
Expected due date if gestational age not remembered | □ Unknown | ||
Birth weight (g) | □ Unknown | ||
Birth length (cm) | □ Unknown | ||
Mode of delivery | □ Vaginal □ C section | □ Unknown |
A | B | C | D | |
CHILD’S PAST MEDICAL HISTORY | ||||
Prior hospitalizations | □ Yes | □ No | □ Unknown | |
Prior surgical therapies (e.g. tonsillectomy, appendectomy) | □ Yes | □ No | □ Unknown | |
Prior lead exposure testing | □ Yes | □ No | □ Unknown | |
If yes, what were the results? | □ Normal | □ Abnormal | □ Unknown | |
Failure to thrive as defined by physician | □ Yes | □ No | □ Unknown | |
Gastrointestinal Conditions | ||||
Inflammatory Bowel Disease (Crohn’s Disease or Ulcerative Colitis) | □ Yes | □ No | □ Unknown | |
Irritable Bowel Syndrome | □ Yes | □ No | □ Unknown | |
Celiac disease | □ Yes | □ No | □ Unknown | |
EoE (Eosinophilic Esophagitis) | □ Yes | □ No | □ Unknown | |
H. pylori Gastric Infection | □ Yes | □ No | □ Unknown | |
Allergic enteritis/milk intolerance | □ Yes | □ No | □ Unknown | |
Other Gastrointestinal Disease: | □ Yes | □ No | □ Unknown | |
If yes, list: | ||||
Developmental delay | □ Yes | □ No | □ Unknown | |
Asthma | □ Yes | □ No | □ Unknown | |
Eczema | □ Yes | □ No | □ Unknown | |
Food allergies | □ Yes | □ No | □ Unknown | |
Medication allergies | □ Yes | □ No | □ Unknown | |
Environmental allergies | □ Yes | □ No | □ Unknown | |
Other | □ Yes | □ No | □ Unknown | |
If yes, list: |
A | B | C | D | |
CHILD’S MEDICATIONS | ||||
Antacids | □ Yes | □ No | ||
If yes, select all that apply: | □ PPI (e.g., Omeprazole - Zegerid, Pantoprazole - Protonix) | |||
□ H2 Blocker (e.g., Famotidine - Pepcid, Ranitidine - Zantac) | ||||
Probiotics | □ Yes | □ No | ||
Vitamin supplementation | □ Yes | □ No | ||
If yes, select all that apply: | □ Vitamin D | |||
□ Vitamin K | ||||
□ Vitamin A | ||||
□ Vitamin B12 | ||||
□ Vitamin E | ||||
□ Other | ||||
Mineral or micronutrient supplementation | □ Yes | □ No | ||
If yes, select all that apply: | □ Calcium | |||
□ Iron | ||||
□ Zinc | ||||
□ Other | ||||
Immunosuppressants or Immunomodulators | ||||
If yes, select all that apply: | □ Oral Steroids | |||
□ IV Steroids | ||||
□ Asthma Inhaler | ||||
□ Tacrolimus/Sirolimus | ||||
□ 6MP | ||||
□ AZA | ||||
□ Other | ||||
Over-the-counter medications | □ Yes | □ No | ||
Other medications | □ Yes | □ No | ||
If yes, list: |
A | B | C | D | |
DIETARY QUESTIONNAIRE | ||||
Questions about Liquids | ||||
Now I would like to ask you about liquids that [NAME] had yesterday during the day or at night. Please tell me about all drinks, whether [NAME] had them at home, or somewhere else. Yesterday during the day or at ight, did [NAME] have...? | ||||
Plain water? | □ Yes | □ No | □ I don’t know | |
Infant formula, such as [insert local names of common formula]? In the United States, for example: Similac, Enfamil, Neocate, Elecare, Happy Baby, Earth’s Best, or Gerber | □ Yes | □ No | □ I don’t know | |
If yes, how many times? | ||||
Milk from animals, including fresh, tinned or powdered? | □ Yes | □ No | □ I don’t know | |
If yes, how many times? | ||||
If yes, was the milk or were any of the milk drinks a sweet or flavored type of milk? | □ Yes | □ No | □ I don’t know | |
Yogurt drinks such as [insert local names of common types of yogurt drinks]? | □ Yes | □ No | □ I don’t know | |
If yes, how many times? | ||||
If yes, was the yogurt or were any of the yogurt drinks a sweetened or flavored type of yogurt drink, such as Danimals or similar liquid yogurt drinks, kefir, or buttermilk ? | □ Yes | □ No | □ I don’t know | |
Chocolate-flavored drinks including those made from syrups or powders? | □ Yes | □ No | □ I don’t know | |
Fruit juice or fruit-flavored drinks including those made from syrups or powders? | □ Yes | □ No | □ I don’t know | |
Sodas, malt drinks, sports drinks or energy drinks? | □ Yes | □ No | □ I don’t know | |
Tea, coffee, or herbal drinks? | □ Yes | □ No | □ I don’t know | |
If yes, were any of these drinks sweetened or flavored? | □ Yes | □ No | □ I don’t know | |
Clear broth or clear soup? | □ Yes | □ No | □ I don’t know | |
Any other liquids? | □ Yes | □ No | □ I don’t know | |
If yes, what was/were the liquids? | ||||
If yes, was the drink or were any of these drinks sweetened or flavored? | □ Yes | □ No | □ I don’t know | |
When did the participant last eat? | □ 0-3 hours ago □ 3-6 hours ago □ 6-12 hours | □ 12-18 hours ago □ 18-24 hours ago | □ I don’t know | |
Questions about Foods | ||||
Now I would like to ask you about the foods that [NAME] ate yesterday during the day or at night. I will ask you about different. types of foods, and I would like to know whether your child ate the food even if it was combined with foods in a mixed dish like [list common local. examples of mixed dishes]. Please do not answer "yes" for any food or ingredient used in a small amount to add flavo to a dish. Yesterday during the day or at night, did [NAME] eat: | ||||
Yogurt, other than yogurt drinks? (i.e. yogurt eaten with spoon) | □ Yes | □ No | □ I don’t know | |
If yes, how many times? | ||||
Porridge, bread, rice, noodles, pasta, or [insert other commonly consumed grains from including foods made from grains like rice dishes, noodle dishes, etc.]? | □ Yes | □ No | □ I don’t know | |
Pumpkin, carrots, sweet red peppers, squash, or sweet potatoes that are yellow or orange inside? [any additions to this list should meet criteria for defining foods and liquids as 'sources' of vitamin A] | □ Yes | □ No | □ I don’t know | |
Plantains, white potatoes, white yams, manioc, cassava or other starchy vegetables like jicama, parsnips, taro root, turnips, breadfruit, etc. [insert other commonly consumed strachy tubers or starchy tuberous roots that are white or pale inside]? | □ Yes | □ No | □ I don’t know | |
Dark green leafy vegetables, such as arugula, spinach, broccoli, kale, watercress, lettuce (e.g. romaine) [insert commonly consumed vitamin A-rich dark green leafy vegetables]? | □ Yes | □ No | □ I don’t know | |
Any other vegetables, such as asparagus, eggplant, avocado, beets, cabbage, cauliflower, green pepper, mushroom, lettuce (e.g. iceberg), celery, tomato, etc. [insert commonly consumed vegetables]? | □ Yes | □ No | □ I don’t know | |
Ripe mangoes, ripe papayas, or other vitamin-A rich fruits like cantaloupe, dried peaches, apricot, or ripe passionfruit | □ Yes | □ No | □ I don’t know | |
Any other fruits, such as as apple, banana, blackberry, blueberry, grapefruit, kiwi, orange, honeydew melon, figs, grapes, etc. [insert commonly consumed fruits]? | □ Yes | □ No | □ I don’t know | |
Liver kidney, heart or other organ meats like gizzard, blood sausage, intestines, etc. [insert commonly consumed organ meats]? | □ Yes | □ No | □ I don’t know | |
Sausages, hot dogs, ham, bacon, salami, canned meat, beef jerky/ biltong, or [insert other commonly consumed processed meats]? | □ Yes | □ No | □ I don’t know | |
Any other meat, such asbeef, pork, lamb, goat, chicken, duck, turkey, deer, or [insert other commonly consumed meat]? | □ Yes | □ No | □ I don’t know | |
Eggs? | □ Yes | □ No | □ I don’t know | |
Fresh fish, dried fish or shellfish? | □ Yes | □ No | □ I don’t know | |
Beans, peas, lentils, nuts, seeds, chickpeas or [insert commonly consumed foods made from beans, peas, lentils, nuts, or seeds]? | □ Yes | □ No | □ I don’t know | |
Hard or soft cheese such as cheddar, gouda, American cheese, Swiss cheese, brie, cottage cheese [insert commonly consumed types of cheese]? | □ Yes | □ No | □ I don’t know | |
Sweet foods such as chocolates, candies, pastries, cakes, biscuits, or frozen treats like ice cream and popsicles, or [insert other commonly consumed sentinel sweet foods]? | □ Yes | □ No | □ I don’t know | |
Chips, crisps, puffs, French fries, fried dough, instant noodles, fried plantain snacks or [insert other commonly consumed sentinel fried and salty foods]? | □ Yes | □ No | □ I don’t know | |
Any other solid, semi-solid or soft foods? | □ Yes | □ No | □ I don’t know | |
If yes, list all the solid, semi-solid, or soft foods that do not fit the food groups above: | ||||
How many times did the participant eat any solid, semi-solid, or soft foods yesterday during the day or night? |