Effects of a Multi-Strain Probiotic Supplement on Gastrointestinal Comfort and General Well-Being in Women: A Randomized, Double-Blind, Placebo-Controlled, Decentralized Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Change in PROMIS Gastrointestinal Gas and Bloating Scale T-score from baseline to week 8
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Active: Multi-strain probiotic dietary supplement (Dietary Supplement)
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.
干预措施: Placebo: Placebo (Dietary Supplement)
结局指标
主要结局
Change in PROMIS Gastrointestinal Gas and Bloating Scale T-score from baseline to week 8
时间窗: 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
次要结局
- Change in PROMIS Gastrointestinal Gas and Bloating Scale T-score from baseline to week 4(From baseline to week 4 assessment)
- Change in PROMIS Gastrointestinal Belly Pain, Constipation, and Diarrhea T-scores from baseline to weeks 4 and 8(From baseline to week 4 and 8 assessments)
- Change in PROMIS Fatigue Short Form T-scores from baseline to week 8(From baseline to week 8 assessment)
- Change in PROMIS Sleep Disturbance Short Form T-scores from baseline to week 8(From baseline to week 8 assessment)
- Change in WHO-5 Well-being Index from baseline to week 8(From baseline to week 8 assessment)
- Stool Frequency(Baseline to Week 8 (assessed weekly))
- Bristol Stool Form Scale(Baseline to Week 8 (assessed weekly))
- Urgency Episodes(From baseline to week 8 (assessed weekly))
- Bloating Severity(From baseline to week 8 (assessed weekly))
- Product Perception Questionnaire(Weeks 4 and 8)