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Probiotics for Obesity

N/A

Recruiting

Led By Arpana Gupta, PhD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 18-50

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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).

Awards & highlights

Study Summary

This trial tested new probiotics to help curb obesity: current standard of care for obesity and food addiction is difficult & lacks efficacy; bariatric surgery is an option but has barriers; new probiotics may provide an alternative way to reduce weight.

Who is the study for?

Adults aged 18-50 with a BMI of 25-40, who are not pregnant or nursing. Excluded if they have Type 1 diabetes, untreated thyroid disease, neurological issues, weigh over 400lbs, had certain abdominal surgeries, major medical conditions as determined by the study doctor, chronic pain or active psychiatric illness including eating disorders in the last two years.Check my eligibility

What is being tested?

This trial is testing whether probiotics can help people lose weight compared to a placebo. It's for those who find current obesity treatments ineffective and want to avoid bariatric surgery due to its risks and recovery time.See study design

What are the potential side effects?

Probiotics are generally safe with minimal side effects. Unlike some obesity medications that may cause adverse reactions, probiotics typically do not lead to significant discomfort or health issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 50 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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).

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Differences in metabolite concentrations pre & post intervention - Blood

Differences in metabolite concentrations pre & post intervention - Stool

Differences in microbiome levels pre & post intervention - Blood

+1 more

Secondary outcome measures

Anthropometrics - BMI

Anthropometrics - waist and hip circumference

Changes in Autonomic Measures - Diastolic & Systolic blood pressure

+9 more

Other outcome measures

Differences in Multimodal Brain Signatures

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: ProbioticActive Control1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,532 Previous Clinical Trials

10,265,168 Total Patients Enrolled

Arpana Gupta, PhDPrincipal InvestigatorThe Regents of the University of California, Los Angeles

2 Previous Clinical Trials

370 Total Patients Enrolled

Tien Dong, MD, PhDPrincipal InvestigatorThe Regents of the University of California, Los Angeles

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are octogenarians being recruited for participation in this investigation?

"As specified by the study's enrollment criteria, participants must be within 18 to 50 years of age."

Answered by AI

Is enrollment in this experiment available to me?

"Eligible candidates for this medical trial must possess an obesity diagnosis and be between the ages of 18-50. 100 patients are required to complete the study in entirety."

Answered by AI

Are there any vacancies for this clinical research currently available?

"Affirmative. Clinicaltrials.gov shows that this medical study is still recruiting patients since it was first posted on July 18th 2023 and last updated on September 8th 2023. They require a total of 100 participants from one location."

Answered by AI

How many participants are allowable in this experiment?

"Affirmative. The information published on clinicaltrials.gov underlines that this medical trial is currently recruiting patients, having been first posted on July 18th 2023 and last updated September 8th 202023. This research endeavour necessitates the recruitment of 100 participants from a single site."

Answered by AI

What goals is this research endeavor striving to attain?

"This clinical trial is aimed at measuring differences in blood metabolites pre and post intervention. Additionally, the study will track changes to heart rate variability, skin conductance response, and diastolic/systolic blood pressure three times - baseline (week 0), mid-study (week 6) and end of study (week 12)."

Answered by AI

Who else is applying?

What site did they apply to?

University of California

What portion of applicants met pre-screening criteria?

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

Need to lose weight. I've lost weight and it all comes back. As I get older it's harder and harder to loose without starving myself.

PatientReceived 2+ prior treatments

I have tried to lose weight, but as I get older, it becomes harder and harder. I have lost weight in the past through diet and exercise, but it has been more difficult to accomplish as I age.

PatientReceived no prior treatments

Recent research and studies

clinicaltrials.govStudy

Probiotic Intervention Study

Arpana Gupta 2023. "Probiotic Intervention Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06030362.

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