Multi-strain Probiotic Supplement for Digestive Comfort and Well-being in Healthy Women

This is a randomized, double-blind, placebo-controlled, decentralized clinical trial evaluating a commercially available multi-strain probiotic dietary supplement for its effects on gastrointestinal comfort and general well-being in healthy women.

All study procedures are conducted remotely through a secure digital research platform, including electronic informed consent, screening, questionnaire completion, supplement compliance tracking, and adverse event reporting. Participants complete a brief weekly diary of bowel habits and a fuller set of questionnaires at baseline, Week 4, and Week 8 covering gastrointestinal symptoms, psychological well-being, sleep, and fatigue. A facial photograph is also collected at baseline and Week 8 as part of an exploratory assessment of skin appearance.

The primary comparison of interest is the change in self-reported gas and bloating symptoms from baseline to Week 8 between the probiotic and placebo groups.

This study evaluates the product's effect on gastrointestinal comfort and general well-being in healthy adults; it is not designed to evaluate the diagnosis, treatment, or management of any disease.

Inclusion criteria

• Self-reported gas and/or bloating occurring on 4 or more days per week for at least the past 6 months
• Mild-to-moderate ongoing gastrointestinal symptoms at screening, defined as a PROMIS Gastrointestinal Gas and Bloating Scale T-score of 55 to 69, inclusive
• Body mass index (BMI) 18.5 to 32.5 kg/m2 (inclusive)
• Self-reported symptoms of hormonal imbalance within the past 3 months, including at least one of the following: irregular or unpredictable menstrual cycles, acne, excess facial or body hair growth, or scalp hair thinning
• If using psychotropic medication (including antidepressants, anxiolytics, mood stabilizers, or stimulants): stable medication and dose for at least three months prior to screening, with no anticipated changes during the study; medication name, dose, and start date recorded at screening
• If using hormonal contraception: stable method for at least three months prior to screening, with no anticipated changes during the study; method and start date recorded at screening
• Willing to abstain from all other probiotic and prebiotic supplements and probiotic-fortified functional foods from screening through study completion
• Willing and able to maintain consistent diet, physical activity, and medication habits for the duration of the study
• Willing and able to provide electronic informed consent and comply with the protocol
• Resident of the United States with access to a smartphone with internet access and a functioning front-facing or rear camera, to allow completion of all online instruments and the skin health selfie assessment
• Able to read and understand English at the 6th-grade level

Exclusion criteria

• Current use of a GLP-1 receptor agonist of any class or type, or use within the 3 months prior to screening
• Use of any probiotic or prebiotic dietary supplement within the 4 weeks prior to screening
• Use of systemic antibiotics within the 4 weeks prior to screening, or anticipated use during the study
• Diagnosed gastrointestinal disease or disorder, including inflammatory bowel disease (Crohn's disease, ulcerative colitis), celiac disease, gastroparesis, gastrointestinal malignancy, or prior bariatric or other major gastrointestinal surgery
• Current or past diagnosis of endometriosis or a thyroid or other endocrine/gynecological disorder, whether or not currently controlled
• Chronic or serious medical conditions, including uncontrolled cardiovascular, metabolic, neurologic, immune (including immunocompromised states), renal, or hepatic disease, or any medical condition deemed exclusionary by the Principal Investigator
• Current or past diagnosis of bipolar I/II disorder, schizophrenia spectrum or other psychotic disorder; psychiatric hospitalization, suicidal ideation, suicide attempt, or self-harm behavior in the past 12 months
• Initiation, discontinuation, or dose change of any psychotropic medication within the 3 months prior to screening
• Allergy or sensitivity to any ingredient in the study product
• History of drug or alcohol abuse in the past 12 months
• Currently pregnant, breastfeeding, or planning to become pregnant during the study period
• Participation in another interventional research study within 30 days prior to screening that could confound the outcomes of this study
• Currently in prison, in custody, or otherwise a ward of the state