Gastrointestinal DiscomfortNCT07831317
Multi-strain Probiotic Supplement for Digestive Comfort and Well-being in Healthy Women
A study testing Active: Multi-strain probiotic dietary supplement in people with Gastrointestinal Discomfort and Bloating, run by Daily Nouri at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Discomfort, Bloating
- What is being tested?
- Active: Multi-strain probiotic dietary supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Alethios
San Francisco, California, 94109
About this study
Official title: Effects of a Multi-Strain Probiotic Supplement on Gastrointestinal Comfort and General Well-Being in Women: A Randomized, Double-Blind, Placebo-Controlled, Decentralized Study
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.
Read the detailed description
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.
- Conditions
- Gastrointestinal Discomfort, Bloating
- Being tested
- Active: Multi-strain probiotic dietary supplement, Placebo: Placebo
- Keywords
- probiotics, bloating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active: Multi-strain probiotic dietary supplementDietary supplement
A capsule-in-capsule dietary supplement containing a seven-strain probiotic blend (12 billion CFU per capsule), taken once daily.
Placebo: PlaceboDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Supplement | Experimental | 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. Receives: Dietary Supplement: Active: Multi-strain probiotic dietary supplement |
| Placebo | Placebo comparator | 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. Receives: Dietary Supplement: Placebo: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From baseline to week 8 assessment
Secondary outcomes (10)
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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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.
Measured: From baseline to week 8 assessment
Stool Frequency
Number of bowel movements per week, self-reported via weekly diary
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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.
Measured: Weeks 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start19 Sep 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal DiscomfortStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daily Nouri
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara A Davis, PhD, RD, Principal investigator, Ingredient Factor, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831317
- Sponsor's protocol ID
- DNO003
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fabbrocini G, Bertona M, Picazo O, Pareja-Galeano H, Monfrecola G, Emanuele E. Supplementation with Lactobacillus rhamnosus SP1 normalises skin expression of genes implicated in insulin signalling and improves adult acne. Benef Microbes. 2016 Nov 30;7(5):625-630. doi: 10.3920/BM2016.0089. Epub 2016 Sep 6.
PubMed 27596801Honda S, Tominaga Y, Espadaler-Mazo J, Huedo P, Aguilo M, Perez M, Ueda T, Sawashita J. Supplementation with a Probiotic Formula Having beta-Glucuronidase Activity Modulates Serum Estrogen Levels in Healthy Peri- and Postmenopausal Women. J Med Food. 2024 Aug;27(8):720-727. doi: 10.1089/jmf.2023.k.0320. Epub 2024 Jun 16.
PubMed 38742994Verdenelli MC, Silvi S, Cecchini C, Orpianesi C, Cresci A. Influence of a combination of two potential probiotic strains, Lactobacillus rhamnosus IMC 501(R) and Lactobacillus paracasei IMC 502(R) on bowel habits of healthy adults. Lett Appl Microbiol. 2011 Jun;52(6):596-602. doi: 10.1111/j.1472-765X.2011.03042.x. Epub 2011 Mar 30.
PubMed 21395626
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Multi-Strain Probiotic Supplement on Gastrointestinal Comfort and General Well-Being in Women: A Randomized, Double-Blind, Placebo-Controlled, Decentralized Study
- ClinicalTrials.gov ID
- NCT07831317
- Acronym / sponsor ID
- DNO003
- Conditions
- Gastrointestinal Discomfort, Bloating
- Keywords
- probiotics, bloating
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Daily NouriIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic Supplement | Experimental | Dietary Supplement: Active: Multi-strain probiotic dietary supplementThe 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 | Placebo comparator | Dietary Supplement: Placebo: PlaceboThe 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. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active: Multi-strain probiotic dietary supplementA capsule-in-capsule dietary supplement containing a seven-strain probiotic blend (12 billion CFU per capsule), taken once daily. | Dietary supplement | Probiotic Supplement |
| Placebo: PlaceboA 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. | Dietary supplement | Placebo |
Primary outcome
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
10 secondary outcomes
Change in PROMIS Gastrointestinal Gas and Bloating Scale T-score from baseline to week 4
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
Time frame: From baseline to week 4 and 8 assessments
Change in PROMIS Fatigue Short Form T-scores from baseline to week 8
Time frame: From baseline to week 8 assessment
Change in PROMIS Sleep Disturbance Short Form T-scores from baseline to week 8
Time frame: From baseline to week 8 assessment
Change in WHO-5 Well-being Index from baseline to week 8
Time frame: From baseline to week 8 assessment
Stool Frequency
Time frame: Baseline to Week 8 (assessed weekly)
Bristol Stool Form Scale
Time frame: Baseline to Week 8 (assessed weekly)
Urgency Episodes
Time frame: From baseline to week 8 (assessed weekly)
Bloating Severity
Time frame: From baseline to week 8 (assessed weekly)
Product Perception Questionnaire
Time frame: Weeks 4 and 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Background: PubMed 27596801Fabbrocini G, Bertona M, Picazo O, Pareja-Galeano H, Monfrecola G, Emanuele E. Supplementation with Lactobacillus rhamnosus SP1 normalises skin expression of genes implicated in insulin signalling and improves adult acne. Benef Microbes. 2016 Nov 30;7(5):625-630. doi: 10.3920/BM2016.0089. Epub 2016 Sep 6.
- Background: PubMed 38742994Honda S, Tominaga Y, Espadaler-Mazo J, Huedo P, Aguilo M, Perez M, Ueda T, Sawashita J. Supplementation with a Probiotic Formula Having beta-Glucuronidase Activity Modulates Serum Estrogen Levels in Healthy Peri- and Postmenopausal Women. J Med Food. 2024 Aug;27(8):720-727. doi: 10.1089/jmf.2023.k.0320. Epub 2024 Jun 16.
- Background: PubMed 21395626Verdenelli MC, Silvi S, Cecchini C, Orpianesi C, Cresci A. Influence of a combination of two potential probiotic strains, Lactobacillus rhamnosus IMC 501(R) and Lactobacillus paracasei IMC 502(R) on bowel habits of healthy adults. Lett Appl Microbiol. 2011 Jun;52(6):596-602. doi: 10.1111/j.1472-765X.2011.03042.x. Epub 2011 Mar 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Barbara A Davis, PhD, RD principal investigator
Ingredient Factor, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active: Multi-strain probiotic dietary supplement in people with Gastrointestinal Discomfort and Bloating, run by Daily Nouri at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alethios (650-206-8006, support@alethios.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07831317, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.