Probiotic Supplement for Digestive Comfort in Healthy Women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled trial evaluates a multi-strain probiotic dietary supplement in healthy women with mild-to-moderate gastrointestinal symptoms and hormonal fluctuation–related concerns. Participants take either the probiotic or placebo once daily for eight weeks, with remote screening, consent, and study activities via a secure digital platform. Primary outcomes assess changes in self-reported gas and bloating from baseline to Week 8, along with measures of sleep, energy, and mood collected through weekly diaries and periodic questionnaires. An exploratory skin appearance assessment is included through baseline and Week 8 photographs. The trial is decentralized and online-only, not designed to diagnose or treat disease.

Why it matters

Who can join: the full rules

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

Where it's running

• Alethios
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: Barbara A Davis, PhD, RD — Ingredient Factor, LLC
• Study coordinator: Alethios
• Email: support@alethios.com
• Phone: 650-206-8006

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.