GUT-FEELINGS: Using Citizen Science for Large-Scale Prebiotic Clinical Trials for Mental Health in Adults, Wave 1
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Change in feelings of anxiety
研究概览
简要总结
The goal of this study is to evaluate the effects of different products in participants experiencing feelings of anxiety. The main question it aims to answer is:
- Do these products affect feelings of anxiety and related wellness outcomes compared with a placebo?
Researchers will compare participants taking active products to those taking a placebo to see whether the active products influence feelings of anxiety and related outcomes, and to monitor safety.
Participants will:
- Be randomly assigned to receive either an active product or a placebo (an inactive look-alike).
- Take their assigned product or placebo without knowing which group they are in until the study is completed.
- Complete evaluations and tasks to track safety, feelings of anxiety, and related health outcomes.
详细描述
This is a parallel group, randomized, double-blind, placebo-controlled study assessing the effects (if any) of different prebiotics (products) on self-reported feelings of anxiety and related health outcomes. The study is conducted in two sequential waves, each enrolling a similar population and evaluating distinct interventions, under a unified master protocol. Participants will not know their study arm assignment until the study is completed.
The master protocol structure permits an efficient shared infrastructure for oversight, data management, safety monitoring, and biospecimen handling while maintaining scientific independence between the two waves. Each participant completes a 17-week study duration consisting of a 12-week double-blind intervention period (daily oral powder sachet consumed with food or beverage) followed by a 4-week washout period. This enables both within-arm time-course modeling and between-arm comparisons across intervention and post-intervention phases.
Following electronic informed consent, identity verification via one-time passcode, and baseline health assessments, participants are stratified to ensure balanced distribution across arms. Within each stratum, participants are randomized to active or shared placebo arms and to compensation tiers that will enable the assessment of how (if) compensation affects study participation and compliance.
To comprehensively track biological dynamics, the trial integrates multi-omic biospecimen collections and digital biomarker telemetry. Participants self-collect stool samples across four timepoints for deep metagenomic sequencing, untargeted fecal metabolomics, and to create a biobank. Finger-prick capillary blood samples are collected via microsampling devices for blood proteomic profiling at two time points. A consented sub-cohort applies an over-the-counter continuous glucose monitor for two weeks to evaluate glucose dynamics. Additional digital health streams include passive nightly wearable telemetry, weekly smartphone-based optical AI facial scans (Intelliprove) tracking physiological vitals, passive GPS-derived home-time proportion metrics, and weekly photographic food recall diaries.
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
- Double (Participant, Investigator)
盲法说明
The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Criteria: 3.1 Inclusion
- •Participants must meet all of the following criteria:
- •Adults aged 21-80 years (inclusive) at the time of electronic informed consent, of any ethnicity, race, or gender identity
- •Assigned sex at birth determines sex-specific PRO branching (e.g., menstrual interference) where applicable
- •Reside in the contiguous 48 states in the United States and is able to provide a valid US shipping address and and 10-digit mobile phone number
- •Per state regulations, individuals residing in New York, New Jersey, and Rhode Island will be excluded
- •Capable of providing voluntary, electronic informed consent and willing to comply with study procedures, including remote biospecimen collection
- •PROMIS Anxiety 8A T-score between 55.0 and 69.9 (inclusive) at screening, corresponding to mild-to-moderate anxiety symptoms.
- •On a stable medication regimen for ≥30 days prior to screening and willing to maintain that regimen for the duration of the trial, unless changes are deemed medically necessary by the participant's healthcare provider. Stable, prescribed psychotropic medications (including SSRIs, SNRIs, and other antidepressants or anxiolytics) are not exclusionary.
- •Willing to take a study product and not know the intervention arm assignment (active or placebo) or the product identity.
- •Reliable daily access to the internet via mobile device or computer
- •3.2 Exclusion
- •Individuals who report any of the following during screening may be excluded from participation:
- •Currently pregnant, planning to become pregnant during the trial, or breastfeeding
- •Unable to read and understand English at a 7th-grade reading level
- •Currently enrolled in another interventional clinical trial or planning to enroll in one during the trial timeline
- •Heavy alcohol consumption (defined for female sex assigned at birth >/= 2 alcoholic beverages/day, male sex assigned at birth >/=3/day) or use of recreational or illicit drugs other than cannabis
- •History of bariatric or weight-loss surgery (e.g., Roux-en-Y gastric bypass, sleeve gastrectomy, adjustable gastric banding, or biliopancreatic diversion).
- •Reports a current diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease).
- •Current or recent (within 3 months) major illness, surgery, or hospitalization posing a known significant safety risk
- •Diagnosis of cardiac dysfunction, severe liver disease, or severe kidney disease that presents a known contraindication to study product ingredients or substantial safety risk:
- •NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure
- •Significant immunocompromise, including diagnosed primary or acquired immunodeficiency, current chemotherapy, current immunotherapy, current use of immunosuppressive medications, or daily corticosteroid dose >5 mg prednisone-equivalent
- •Antibiotic use (oral, IV) currently or within 30 days prior to screening
- •Plans to start a new structured dietary regimen (including new probiotic or prebiotic supplementation outside the study product) during the trial period
- •Use of medications with a well-established interaction posing a substantial safety risk with study product ingredients
- •Active suicidality as determined by a response of 3 in item 9 of the PHQ-9 score at screening
- •Known hypersensitivity to any component of the study products
- •Wave-specific
排除标准
- •per Subprotocol A (Wave 1) or Subprotocol B (Wave 2)
- •Note on medication exclusions: routine prescription medications (including antihypertensives, anticoagulants at standard outpatient doses, antiseizure medications, and medications carrying a grapefruit-consumption warning) are not categorically excluded. Specific medications posing a documented safety risk in combination with the food ingredients (products) are addressed by the study screening Q-bank.
- •Participants residing in the states of New York, New Jersey, or Rhode Island are not eligible to participate in the study. This restriction is due to state regulatory requirements governing direct-to-consumer at-home laboratory specimen collection and processing that cannot be accommodated within the fully decentralized design of the study. No alternative collection pathway is available under the current protocol.
- •To ensure compliance, state-of-residence logic is built into the enrollment platform. Participants who indicate a residential address in New York, New Jersey, or Rhode Island will not be eligible. This automated screening ensures that ineligible participants are not inadvertently enrolled in the study.
研究组 & 干预措施
Active Gut Feeling Product 1
Active Gut Feeling Product 1
干预措施: Active Gut Feeling Product 1 (Other)
Active Gut Feeling Product 2
Active Gut Feeling Product 2
干预措施: Active Gut Feeling Product 2 (Other)
Placebo Gut Feeling Product Control
Placebo Gut Feeling Product Control
干预措施: Placebo Gut Feeling Control Product (Other)
结局指标
主要结局
Change in feelings of anxiety
时间窗: 18 weeks
Change in feelings of anxiety: Difference between rates of change over time in feelings of anxiety score as assessed by PROMIS Anxiety 8A (scale 8-40; with higher scores corresponding to more severe anxiety)
次要结局
- Change in sleep(18 weeks)
- Change in severity of generalized anxiety(18 weeks)
- Change in the severity of depression(18 weeks)
- Change in recovery from stress and adversity(18 weeks)
- Change in measure of self-perceived success(18 weeks)
- Change in depression, anxiety, and stress(18 weeks)