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160 Participants NeededMy employer runs this trial

Probiotic Supplement for Gastrointestinal Discomfort

A
Overseen ByAlethios
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Daily Nouri

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

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Barbara A Davis, PhD, RD

Principal Investigator

Ingredient Factor, LLC

Are You a Good Fit for This Trial?

This trial is for healthy women who have mild-to-moderate stomach discomfort, like gas or bloating, and also experience symptoms related to hormonal changes. Participants must be able to take part in an online study from home.

Inclusion Criteria

Willing and able to provide electronic informed consent and comply with the protocol
Body mass index (BMI) 18.5 to 32.5 kg/m2 inclusive
Willing to abstain from all other probiotic and prebiotic supplements and probiotic-fortified functional foods from screening through study completion
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Exclusion Criteria

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
Allergy or sensitivity to any ingredient in the study product
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What Are the Treatments Tested in This Trial?

Interventions

  • Multi-strain probiotic dietary supplement

Trial Overview

The study tests a daily multi-strain probiotic supplement versus a placebo (inactive capsule) over 8 weeks. Women are randomly assigned to one group without knowing which they get. Researchers track digestive comfort, sleep, energy, and mood.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Probiotic SupplementExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Daily Nouri

Lead Sponsor

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