Recruiting

Probiotic

Sponsor:

Daily Nouri

Code:

NCT07831317

Conditions

Gastrointestinal Discomfort

Bloating

Eligibility Criteria

Sex: Female

Age: 25 - 45

Healthy Volunteers: Accepted

Interventions

Active: Multi-strain probiotic dietary supplement

Placebo: Placebo

Study Details

Brief summary:

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.

Conditions

Gastrointestinal Discomfort

Bloating

Study ID

NCT07831317

Start date

Sep 19, 2026

Status verified date

Sep, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 25 - 45

Healthy Volunteers: Accepted

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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Probiotic Supplement

The study product is a commercially available multi-strain probiotic dietary supplement containing a blend of probiotic strains. Participants take one capsule by mouth daily, with or without food, for 8 weeks.

placebo comparator: Placebo

The placebo is manufactured to be visually identical to the active study product in appearance, size, color, weight, and packaging, but contains no active ingredients. Participants take one capsule by mouth daily, with or without food, for 8 weeks.

Interventions

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.

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 measure

  • Change in PROMIS Gastrointestinal Gas and Bloating Scale T-score from baseline to week 8 [ Time Frame: From baseline to week 8 assessment ]

Central Contacts and Locations

Central contacts

Alethios

650-206-8006support@alethios.com

Locations

Alethios

Recruiting

San Francisco, California, United States, 94109

More Information

Sponsor

Daily Nouri

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

Keywords

  • probiotics
  • bloating

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Daily Nouri on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.