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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Daily Nouri • ClinicalTrials.gov ID: NCT07831317

Registry updated: 2026-09-25
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Description

This study looks at whether a daily probiotic supplement can help improve mild-to-moderate stomach and digestive symptoms, such as gas and bloating, in women who also experience symptoms commonly associated with hormonal fluctuations. Participants take either the probiotic or a placebo (a look-alike capsule with no active ingredients) once a day for 8 weeks, without knowing which one they are taking. Researchers will compare changes in digestive comfort, sleep, energy, and mood between the two groups over the study period. The study is conducted entirely online, so participants can take part from home.

Interventions

  • Active: Multi-strain probiotic dietary supplement (Dietary supplement)
    A capsule-in-capsule dietary supplement containing a seven-strain probiotic blend (12 billion CFU per capsule), taken once daily.
  • Placebo: Placebo (Dietary supplement)
    A capsule-in-capsule placebo manufactured to be visually identical to the active study product in appearance, size, color, weight, and packaging, containing no active ingredients, taken once daily.

Eligibility criteria

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

Conditions

Gastrointestinal Discomfort Bloating

Locations

  • Alethios — San Francisco, California, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record