Probiotic Intervention Study for Obesity and Food Addiction

This study is looking at whether a daily dietary supplement, either a Probiotic or a Placebo (an inactive substance), can help people with obesity and food addiction. Researchers will study changes in certain substances in your blood and stool, as well as changes in the bacteria in your gut (microbiome), before and after taking the supplement for three months. The goal is to see if the Probiotic has an effect on these measurements. You may be able to join if you are between 18 and 50 years old, have a BMI (Body Mass Index) between 25 and 40, and are not pregnant or nursing. People with certain health conditions like Type 1 diabetes or recent drastic weight loss cannot participate. The current status of this study is unclear, but it aims to enroll 100 participants.

Study design
This is an interventional study, meaning participants will receive either a Probiotic or a Placebo dietary supplement. It plans to enroll 100 participants.
What's involved
You would take a dietary supplement once daily for 3 months. You would also provide stool samples three times and blood samples three times over the 12-week study period.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed for 12 weeks, with final measurements taken at the end of the 3-month intervention.

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NCT06030362

Probiotic Intervention Study

Recruiting
NAAges 18–50InterventionalTreatment
University of California, Los Angeles
~100 participants
Updated 2026-03-27 on ClinicalTrials.gov
What's tested:ProbioticPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Differences in metabolite concentrations pre & post intervention - Stool
Measured over 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).
+5 more outcomes measured
Obesity
Food Addiction
1 sites across 1 states
California1
  • Arpana Gupta, PhD · PRINCIPAL_INVESTIGATOR · The Regents of the University of California, Los Angeles
  • Tien Dong, MD, PhD · PRINCIPAL_INVESTIGATOR · The Regents of the University of California, Los Angeles

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Eligibility criteria

Inclusion

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

Exclusion

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.).
  • Differences in metabolite concentrations pre & post intervention - StoolCollected 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).

    Measurement of metabolomics via stool specimen.

  • Differences in metabolite concentrations pre & post intervention - BloodCollected three times, once at baseline appointment (week 0), once at mid-study appointment (week 6), and once at the final 3month appointment (week 12).

    Measurement of metabolomics via blood specimen.

  • Differences in microbiome levels pre & post intervention - StoolCollected 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).

    16S RNA sequencing to measure microbiome levels via stool specimen.

  • Differences in microbiome levels pre & post intervention - BloodCollected three times, once at baseline appointment (week 0), once at mid-study appointment (week 6), and once at the final 3month appointment (week 12).

    16S RNA sequencing to measure microbiome levels via blood specimen.

  • Differences in microbiome levels pre & post intervention - StoolCollected 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).

    Shotgun metagenomics, sequencing to measure microbiome levels via stool specimen.

  • Differences in microbiome levels pre & post intervention - BloodCollected three times, once at baseline appointment (week 0), once at mid-study appointment (week 6), and once at the final 3month appointment (week 12).

    Shotgun metagenomics, sequencing to measure microbiome levels via blood specimen.