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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
160
A capsule-in-capsule dietary supplement containing a seven-strain probiotic blend (12 billion CFU per capsule), taken once daily.
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.
Alethios
San Francisco, California, United States
Change in PROMIS Gastrointestinal Gas and Bloating Scale T-score from baseline to week 8
Participants rate each item on a 5-point frequency scale (Never, Rarely, Sometimes, Often, Always) reflecting the past 7 days
Time frame: From baseline to week 8 assessment
Change in PROMIS Gastrointestinal Gas and Bloating Scale T-score from baseline to week 4
Participants rate each item on a 5-point frequency scale (Never, Rarely, Sometimes, Often, Always) reflecting the past 7 days
Time frame: From baseline to week 4 assessment
Change in PROMIS Gastrointestinal Belly Pain, Constipation, and Diarrhea T-scores from baseline to weeks 4 and 8
Participants rate each item on a 5-point frequency scale (Never, Rarely, Sometimes, Often, Always) reflecting the past 7 days
Time frame: From baseline to week 4 and 8 assessments
Change in PROMIS Fatigue Short Form T-scores from baseline to week 8
Participants respond to 4 items about the past 7 days using a 5-point scale (Not at all, A little bit, Somewhat, Quite a bit, Very much).
Time frame: From baseline to week 8 assessment
Change in PROMIS Sleep Disturbance Short Form T-scores from baseline to week 8
Participants respond to 4 items about the past 7 days using 5-point response scales that vary by item (e.g., Very good/Good/Fair/Poor/Very poor for sleep quality; Not at all/A little bit/Somewhat/Quite a bit/Very much for other items).
Time frame: From baseline to week 8 assessment
Change in WHO-5 Well-being Index from baseline to week 8
Participants respond to 5 items about the past two weeks using a 6-point scale (All of the time, Most of the time, More than half of the time, Less than half of the time, Some of the time, At no time), each scored 0 to 5.
Time frame: From baseline to week 8 assessment
Stool Frequency
Number of bowel movements per week, self-reported via weekly diary
Time frame: Baseline to Week 8 (assessed weekly)
Bristol Stool Form Scale
A 7-point ordinal scale classifying stool consistency. Scores range from 1 (separate hard lumps) to 7 (watery, no solid pieces); types 3-4 are considered typical. Classification scale, not directional.Unit of Measure: Scores on a scale (1-7)
Time frame: Baseline to Week 8 (assessed weekly)
Urgency Episodes
Number of self-reported episodes of bowel urgency per week, captured via weekly diary. Unit of Measure: Episodes per week
Time frame: From baseline to week 8 (assessed weekly)
Bloating Severity
Self-reported bloating severity over the past week, captured via weekly diary. Scored 0-10, with higher scores indicating greater bloating severity. Unit of Measure: Units on a scale (0-10, higher scores indicate greater bloating severity)
Time frame: From baseline to week 8 (assessed weekly)
Product Perception Questionnaire
Participant-reported product experience and perception, assessed via a researcher-developed questionnaire covering product experience (ease of routine integration, ease of swallowing, gastric tolerability), perceived benefit across digestion, regularity, bloating, mood, energy, sleep, and skin, overall satisfaction and repurchase intent, and dosing pattern. Items are rated on a 5-point agreement scale (Strongly disagree, Disagree, Neither agree nor disagree, Agree, Strongly agree), except the dosing-pattern item, which is multiple choice.
Time frame: Weeks 4 and 8
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.