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 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT03277157
Eligibility Criteria:
Inclusion Criteria:
* Are willing and able to provide informed consent.
* Have confirmed diagnosis of PWS
* Are willing to have height and weight measured and provide demographic information (e.g. age, race, sex)
* Are 18-75 years of age
* Are willing to consume B. lactis B94 and placebo each for 4-week periods
* Are willing to complete a daily questionnaire throughout the 20-week period.
* Are willing to complete the Gastrointestinal Symptom Rating Scale (GSRS) monthly throughout the 20-week study
* Are willing to provide information about their dietary intake for 3-days every 4 weeks
* Are willing to provide a valid social security for study payment purposes
Exclusion Criteria:
* Have a milk protein allergy
* Are currently taking medications for diarrhea
* Are currently taking probiotics supplements and do not want to discontinue prior to the start of the baseline period (i.e. those that discontinue will be included)
* Have previously or are currently being treated for any gastrointestinal diseases such as (gastric ulcers, Crohn's, Celiac, ulcerative colitis, etc.).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03277157
Study Brief:
Protocol Section:
NCT03277157