Multi-strain Probiotic Supplement for Digestive Comfort and Well-being in Healthy Women
Effects of a Multi-Strain Probiotic Supplement on Gastrointestinal Comfort and General Well-Being in Women: A Randomized, Double-Blind, Placebo-Controlled, Decentralized Study
- Gastrointestinal Discomfort
- Bloating
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- Daily Nouri
- Enrolment target
- 160
- Started
- 19 September 2026
- Main results due
- 1 March 2027
- Study sites
- 1
- Registry updated
- 25 September 2026
Can you take part?
- Ages 25 years to 45 years.
- Women only.
- Healthy volunteers can take part.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(1)
Alethios
San Francisco, California, United States
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07831317. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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