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:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT04531033
Eligibility Criteria:
Inclusion Criteria:
* Participants will be male or female between the ages of 18-55 years;
* Participants will be apparently healthy and free from disease, as determined by a health history questionnaire;
* Participants will not be excluded if he or she has been clinically diagnosed with a carbohydrate malabsorption disorder, or is or has been prescribed to take prescription or over-the-counter medication for such;
* Participant has self-diagnosed or otherwise avoids consuming dairy, lactose, and other dairy-containing products, or regularly consumes Lactase enzymes for digestive support;
* Participant agrees and can comply with the study protocol;
* Participant provides signed and dated informed consent to participate in the study.
Exclusion Criteria:
* Participant is or may be pregnant, is trying to become pregnant, or is breastfeeding;
* Participant currently uses, or has discontinued the use of nicotine-containing products within twelve (12) months of the start of the study;
* Participant lives or works within an environment that chronically exposes the subject to second-hand smoke;
* Participant currently uses, or has discontinued the use of recreational drugs or medicinal marijuana within twelve (12) months of the start of the study;
* Participant has been clinically diagnosed with a digestive disorder such as gastrointestinal disease, chronic diarrhea or constipation, irritable or inflammatory bowel syndrome, Crohn's disease, or is, or has been prescribed to take prescription or over-the-counter medication for such;
* Participant has ever undergone gastric bypass surgery, or has undergone an abdominal or other gastrointestinal surgery within twelve (12) months of the start of the study;
* Participant is taking, or has taken antibiotic medications within two (2) weeks of the start of the study;
* Participant has undergone a colonoscopy within two (2) weeks of the start of the study, or is scheduled to receive a colonoscopy during the study;
* Participant has undergone a barium study or received an enema within two (2) weeks of the start of the study, or is scheduled to, or receives such during the study;
* Participant is taking, or has taken probiotics within two (2) weeks of the start of the study;
* Participant uses lactose digesting enzymes during the study;
* Participant is taking, or has taken weight loss, prebiotic \[e.g., fructo- or galacto-oligosaccharides (FOS or GOS), psyllium, or insulin fiber, etc.\], or laxative / stool softener dietary supplements, over-the-counter, or prescription medications within two (2) weeks of the start of the study;
* Participant is allergic to any ingredient present within the dietary supplement or placebo treatment;
* Participant reports any unusual adverse events associated with this study that, in consultation with the study investigators or the participant's doctor recommends removal from the study;
* Participant fails to comply with the study protocol.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04531033
Study Brief:
Protocol Section:
NCT04531033