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Probiotic Intervention Study
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.
Conditions:
🦠 Obesity 🦠 Food Addiction
🗓️ Study Start (Actual) 18 July 2023
🗓️ Primary Completion (Estimated) 31 December 2025
✅ Study Completion (Estimated) 31 July 2026
👥 Enrollment (Estimated) 100
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Los Angeles, California, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Ages 18-50
    • * BMI 25-40
    • * Male and Female
    • * Not Pregnant or Nursing

    Exclusion Criteria:

    • * Co-morbidities including but not limited to:
    • * Type 1 (insulin dependent) diabetes
    • * vascular disease
    • * drastic weight loss (more than 10lbs over the preceding 2months)
    • * frequent strenuous exercise (i.e. marathon runners/heavy weight lifting)
    • * abdominal surgeries including weight loss surgery or partial/complete resection of stomach or bowel
    • * untreated thyroid disease
    • * neurological disease
    • * Major medical condition the PI/MD feels would put the subject at risk or interfere with data collection.
    • * Chronic pain
    • * Diagnosed DSM IV active psychiatric illness including eating disorders. Must not be active or present for at least 2 years. Participants with a positive endorsement on the MINI+ will be excluded.
    • * Using medications known to affect hunger/satiety/appetite
    • * Pregnant, lactating, postpartum less than 6months.
    • * Women of childbearing potential who are not practicing birth control or are planning to get pregnant during the study.
    • * Use of oral/IV antibiotics within the last 3 months
    • * Use of probiotics in the last 3 months.
    • * Heavy use of alcohol and drugs will be determined by a positive endorsement on the MINI+. If the MINI+ is positive for alcohol or drug dependence or abuse, the participant will be excluded. In regards to tobacco use, participants will be excluded if they smoke more than 1/2 pack per day.
    • * Cannabis use will not be exclusionary. If the MINI+ is positive for drug dependence or abuse, the participant will be excluded.
    • * Significant change in usual diet and/or weight loss of more than 10lbs in the last 2 months.
    • * Anyone taking medicines on the medication exclusion list.
    • * Non-English Speakers (due to the use of validated questionnaires and limited availability of translated copies, participants must be fluent in English so that they will be able to read and follow directions easily.
    • * Maintenance pharmacotherapies will not be exclusionary so long as they have been on a stable dose for 6months.
    • * Body weight at enrollment greater than 400lbs.
    • * Exclude from Optional MRI if: participant is unable to safely participate in the MRI (claustrophobia, presence of devices affected by MRI such as pacemakers, neurostimulators, metallic foreign bodies, etc.).
Ages Eligible for Study: 18 Years to 50 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 4 August 2023
  • First Submitted that Met QC Criteria 6 September 2023
  • First Posted 11 September 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 23 July 2024
  • Last Update Posted 25 July 2024
  • Last Verified July 2024
I'm interested ...!!