Recruiting

Probiotic

Sponsor:

UCLA

Code:

NCT06030362

Conditions

Obesity

Food Addiction

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Probiotic

Placebo

Study Details

Brief summary:

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 ID

NCT06030362

Start date

Jul 18, 2023

Status verified date

Mar, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

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.).

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Probiotic

placebo comparator: Placebo

Interventions

Probiotic

Dietary Supplement taken once daily for 3 months (90 days).

Placebo

Dietary Supplement taken once daily for 3 months (90days).

Primary outcome measure

  • Differences in metabolite concentrations pre & post intervention - Stool [ Time Frame: Collected three times by the participant at home, once at baseline (week 0), once at mid-study (week 6), and once at the final 3month appointment (week 12). ]
  • Differences in metabolite concentrations pre & post intervention - Blood [ Time Frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (week 6), and once at the final 3month appointment (week 12). ]
  • Differences in microbiome levels pre & post intervention - Stool [ Time Frame: Collected three times by the participant at home, once at baseline (week 0), once at mid-study (week 6), and once at the final 3month appointment (week 12). ]
  • Differences in microbiome levels pre & post intervention - Blood [ Time Frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (week 6), and once at the final 3month appointment (week 12). ]
  • Differences in microbiome levels pre & post intervention - Stool [ Time Frame: Collected three times by the participant at home, once at baseline (week 0), once at mid-study (week 6), and once at the final 3month appointment (week 12). ]
  • Differences in microbiome levels pre & post intervention - Blood [ Time Frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (week 6), and once at the final 3month appointment (week 12). ]

Central Contacts and Locations

Central contacts

Allison Vaughan, MPH

3108257206GuptaLab@mednet.ucla.edu

Locations

University of California

Recruiting

Los Angeles, California, United States, 90095

Contacts

Allison Vaughan, MPH

3108257206GuptaLab@mednet.ucla.edu

More Information

Sponsor

University of California, Los Angeles

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Keywords

  • Probiotic
  • Dietary Supplement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-03-27.