Multi-strain Probiotic Supplement for Digestive Comfort and Well-being in Healthy Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-45
SponsorDaily Nouri
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Active: Multi-strain probiotic dietary supplement
Dietary supplementA capsule-in-capsule dietary supplement containing a seven-strain probiotic blend (12 billion CFU per capsule), taken once daily.
Placebo: Placebo
Dietary supplementA 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.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Probiotic SupplementExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 assessmentSecondary outcomes
1
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 assessment2
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 assessments3
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 assessment4
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 assessmentOther outcomes
1
Change in Automated Skin Appearance Parameters
At baseline and Week 8, participants capture a facial photograph within the study application following standardized on-screen guidance (front-facing, neutral expression, indirect daylight, no makeup). Images are analyzed by a contracted automated image analysis service that returns quantitative skin appearance parameters on a continuous 0 to 100 scale, with 0 representing the most pronounced visible presentation of the parameter and 100 representing the least visible presentation (i.e., a more favorable appearance). Pre-specified parameters are acne, redness, pigmentation, lines, and skin uniformity. These are image-derived appearance measures, not clinical or diagnostic assessments.
Time frame
Baseline to Week 8Sponsors and contacts
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Source ClinicalTrials.gov