NCT07831317 · Daily Nouri
Multi-strain Probiotic Supplement for Digestive Comfort and Well-being in Healthy Women
What this study is about
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.
View original scientific 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
DIETARY_SUPPLEMENT
Active: Multi-strain probiotic dietary supplement
A capsule-in-capsule dietary supplement containing a seven-strain probiotic blend (12 billion CFU per capsule), taken once daily.
DIETARY_SUPPLEMENT
Placebo: Placebo
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.
Primary outcome measures
Change in PROMIS Gastrointestinal Gas and Bloating Scale T-score from baseline to week 8
Time frame: From baseline to week 8 assessment
Participants rate each item on a 5-point frequency scale (Never, Rarely, Sometimes, Often, Always) reflecting the past 7 days
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- San Francisco, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 25, 2026 · Source of record for eligibility and locations