BridgeMD
New treatment option for Obesity
Official title Probiotic Intervention Study
ClinicalTrials.gov ID: NCT06030362
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50. Healthy volunteers may be eligible.
You may be able to join if
- Ages 18-50
- BMI 25-40
- Male and Female
- Not Pregnant or Nursing
You likely can't join if
- 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
See the full eligibility criteria
- Ages 18-50
- BMI 25-40
- Male and Female
- Not Pregnant or Nursing
- 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...
- 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.).
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.