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Probiotic Intervention Study

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Notable Primary endpoints: details revised at 6 of 6 entries Show 6 more changesShow less
    • Trial completed
    • Primary completion date changed from estimate of Dec 31, 2026 to Feb 19, 2026
    • Enrollment target: estimated 100 to confirmed 106
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints: details revised at 7 of 12 entries
    • Site details revised
  2. Notable Primary completion date: Dec 31, 2025 to Dec 31, 2026
    • Study completion date: Jul 31, 2026 to Jul 31, 2027
    • Site contact updated
    v5
  3. Minor 2 versions Re-verified since Jul 23, 2024, no change to tracked fieldsv3-v4
  4. Minor Secondary endpoints: details revised at 3 of 12 entriesv2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The current standard of care for obesity is the optimal management of comorbid conditions such as diabetes and hyperlipidemia, and counseling on diet, weight loss, or increased physical activity programs. However, lifestyle, diet, and behavioral interventions may provide between 7-10% reduction in initial weight and even fewer with long-term weight loss. In severely obese patients (BMI\>40 or BMI\>35 with comorbidities), bariatric surgery is also a potential treatment, but there is a high barrier for patients to undergo surgery for weight loss. These barriers include an aversion to major abdominal surgery, long recovery time, potential risk of vitamin deficiency, and risk for abdominal pain. For these reasons, there is a paramount need for other treatments for obesity and for food addiction. The current standard of care for obesity and food addiction is difficult to implement and lacks sustained efficacy. Most struggle to complete treatment, lose minimal weight, lack sustained weight loss, and engage in the well-known "YoYo" diet phenomenon. While bariatric surgery is currently the only effective treatment for obesity, there are several barriers associated with it such as eligibility requirements, invasiveness, difficult recovery, and cost making it not readily available for everyone. Some approved medications that help with obesity, such as orlistat, lorcaserin, or naltrexone-bupropion, have not been widely adopted by providers or patients due to their limited responses and adverse side effects. Probiotic cocktails have shown to be safe with little to no side effects. Preclinical models of probiotics demonstrate the ability to curb obesity in animal models. Therefore, a probiotic that is able to show significant weight loss along with lifestyle modifications would be highly adopted and desirable.
Trial Details
NCT Number NCT06030362
Lead Sponsor University of California, Los Angeles
Conditions
(from sponsor)
Obesity, Food Addiction
Related terms Food Addiction, Obesity
Enrollment 106 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov