Is NCT07752823 recruiting in Del Mar, CA?

Yes, NCT07752823 is currently recruiting participants at its Del Mar, CA location. This sleep disturbance clinical trial is actively enrolling qualified participants.

How do I join the sleep disturbance clinical trial in Del Mar?

To join this clinical trial in Del Mar, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Del Mar clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Sleep Disturbance Clinical Trial in Del Mar, CA

About This Sleep Disturbance Study in Del Mar

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.

Sponsor: Holobiome, Inc.

Who Can Participate

Inclusion Criteria

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

Exclusion Criteria

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 exclusion criteria 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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Del Mar?

Yes, this clinical trial (NCT07752823) has an active research site in Del Mar, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Sleep Disturbance Treatment Options in Del Mar, CA

If you're searching for sleep disturbance treatment options in Del Mar, CA, this clinical trial (NCT07752823) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Del Mar research site is actively enrolling participants for this clinical trial. You'll receive care from experienced sleep disturbance specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all sleep disturbance clinical trials near you to find additional studies recruiting in your area.

Sleep Disturbance Clinical Trial in Del Mar, CA

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