NCT06244186Completed
The Effect of Lactobacillus Delbrueckii Subsp. Bulgaricus on Human's Weight Reduction
Source: ClinicalTrials.gov · Last updated 6 Feb 2024
Brief summary (registry, in English)
To evaluate the improvement in weight, body fat, and BMI after adding probiotics as a once-daily therapy for 84 days in overweight individuals.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 2 Jan 2024
- Start date
- 10 Sept 2021
- Primary completion date
- 1 Nov 2022
- Lead sponsor
- China Medical University Hospital
- Diseases
- Obesity
- NCT number
- NCT06244186
What you commit to
- Study type: Interventional
- Participants enrolled: 36
- From 10 Sept 2021 to the primary completion date, 1 Nov 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Short-term use of steroids, NSAIDs, immunosuppressive drugs, interferons, immunomodulators, or any changes in the dose of long-term medications within the last month
- Use of any weight-loss drugs in the last three months (including Orlistat, Lorcaserin, and liraglutide)
- History of allergy to the investigational product
Other illness
- History of diabetic ketoacidosis
- Medical records indicating the occurrence of cerebrovascular disease, acute myocardial infarction, coronary artery bypass surgery, placement of coronary artery stents, or peripheral vascular disease within the last 6 months
- Occurrence of acute infectious diseases within the last month and antibiotic use for \> 7 days
- History of any cancer or undergoing cancer treatment in the past 5 years
- History of alcohol abuse
Lab values
- Impaired kidney function (eGFR \< 30 mL/min/1.73 m2)
Other
- Abnormal liver function (GOT or GPT greater than 3 times the normal upper limit) or liver cirrhosis
- Participation in any other interventional clinical research within the last month
- Pregnant and breastfeeding women
- Participants deemed unsuitable for inclusion by the principal investigator
Who the study is looking for
- Age ≥ 20 years old
- Overweight (BMI ≥ 23) or body fat percentage ≥ 25% for males and ≥ 30% for females
- Having any of the following risk factors: Atherosclerotic cardiovascular disease, type 2 diabetes, age ≥ 45 years for males, ≥ 55 years for females or postmenopausal, hypertension, dyslipidemia (total cholesterol \> 200 mg/dL or low-density lipoprotein cholesterol \> 130 mg/dL or triglycerides \> 130 mg/dL), high-density lipoprotein cholesterol \< 40 mg/dL
- If routinely taking medication for lowering blood glucose, blood pressure, or lipid levels, there should not be significant dosage changes within the past three months
- Being willing to participate after receiving an explanation from the physician, completing the trial plan, and signing the consent form
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.