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 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT07215351
Eligibility Criteria:
Inclusion Criteria:
* experience regular (2 or more days per week) bloating or constipation
* able to fast a minimum of 12 hours prior to testing visit
Exclusion Criteria:
* pregnant, planning to become pregnant, or breastfeeding
* sensitivity or allergic to any components of the study product (cascara sagrada bark powder, cape aloe leaves extract, senna leaf powder, frangula bark powder fennel seed powder, bentonite clay, burdock root powder, licorice root extract, slippery elm bark powder, Capiscum annuum L. Fruit powder, milk thistle seed powder, hydroxypropyl methylcellulose, cellulose, and silicon dioxide).
* experienced a severe allergic reaction that resulted in emergency care
* diagnosed with medical disorders linked to digestive/gut health such as celiac disease, crohn's disease, gastroesophageal reflux disease, heartburn, irritable bowel syndrome, ulcerative colitis, ulcers, etcetera.
* experiencing regular diarrhea
* active infection or illness
* diabetic
* hypertensive
* cardiovascular disease
* breast, uterine, or ovarian cancer
* uterine fibroids or endometriosis
* taking medications or supplements that may alter gut health including but not limited to diuretics, laxatives, anti-diarrheal, anticholinergic agents, or antispasmodic agents.
* previous adverse experience with laxatives
* taking medications known to interact with the dietary supplement's ingredients including blood pressure medications, anticoagulants, antiplatelets, blood thinners, cholesterol-lowering medications, diuretics, water pills, estrogen based contraceptives, non-steroidal anti-inflammatory drugs, digoxin, corticosteroids, Monoamine oxidase inhibitors, insulin, medications processed in the liver, diclofenac, fluvastatin, glipizide, ibuprofen, piroxicam, phenytoin, phenobarbital, or secobarbital.
* tobacco user
* strenuous activity within 24 hours of testing visits
* caffeine within 24 hours of testing visit
* alcohol within 24 hours of testing visit
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07215351
Study Brief:
Protocol Section:
NCT07215351