Probiotic Intervention Study

NCT ID: NCT06030362

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-18
• Study Completion Date: 2026-07-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Probiotic

Group Type: ACTIVE_COMPARATOR

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Probiotic

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Arpana Church

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arpana Gupta, PhD

Role: PRINCIPAL_INVESTIGATOR

The Regents of the University of California, Los Angeles

Tien Dong, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Regents of the University of California, Los Angeles

Locations

University of California

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Allison Vaughan, MPH

Role: CONTACT

GuptaLab@mednet.ucla.edu

3108257206

Facility Contacts

Allison Vaughan, MPH

Role: primary

GuptaLab@mednet.ucla.edu

310-825-7206

Other Identifiers

IRB 22-000796

Identifier Type: -

Identifier Source: org_study_id