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 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 1:11 AM
NCT ID:
NCT01463293
Eligibility Criteria:
Inclusion Criteria:
* Age 18 to 70 years
* Body mass index between 18.5 and 34.9 kg/m2
* Self-reported unsatisfactory defecation due to infrequent stools and/or difficult stool passage, which includes at least one of the following: symptoms of straining, difficulty expelling stool, a sense of incomplete evacuation, hard or lumpy stools, prolonged time to stool, or a need for manual maneuvers to pass stool.
* Estimated stool consistency \< 4.0 on BSSF (self-reported at screening) within the past month prior to enrollment.
* Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects
* Consent to the study and willing to comply with study product and methods
Exclusion Criteria:
* Major gastrointestinal complication (e.g. Crohn's disease, ulcer)
* Prior abdominal surgery that, in the opinion of the investigator, may present a risk for the subject or confound study results
* Clinically significant underlying systemic illness that may preclude the subject's ability to complete the trial or that may confound the study outcomes (e.g. bowel cancer, prostate cancer, terminal illness)
* Daily consumption of probiotics, prebiotics, fermented milk, and/or yogurt within 2 weeks of screening and throughout the trial other than the provided study products
* Non-laxative constipation medication use within 2 weeks of screening, laxative use within 48 hours of screening (rescue medication allowed for intolerable symptoms during study)
* Daily use of anticholinergic agents, opioid analgesics, calcium supplements, calcium-channel blockers, and NSAIDs
* Anticipated major dietary or exercise changes during the study
* Systemic steroid use
* Eating disorder
* Contraindication to dairy products (e.g., intolerance to lactose or any substance in the study product)
* History of alcohol, drug, or medication abuse
* Pregnant or lactating female, or pregnancy planned during study period
* Participation in another study with any investigational product within 30 days of screening
* Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01463293
Study Brief:
Protocol Section:
NCT01463293