NCT06815926Completed
Clinical Trial to Evaluate the Effect of a Probiotic Product on Weight
Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy of a Probiotic Product in Weight Control
Source: ClinicalTrials.gov · Last updated 17 Jul 2025
Brief summary (registry, in English)
The study of the intestinal microbiota and its relationship with health and disease, as well as the use of probiotics as effective alternative treatments to improve people's well-being is a field of growing research in recent years. Overweight and obesity are increasingly common due to the current lifestyle, but this is not incompatible with the growing interest of the population in taking care of themselves, both physically and psychologically, and, in general, the interest in food supplements, including those based on probiotics, is increasingly common. The objective of the clinical trial is to evaluate the effectiveness of a food supplement based on probiotics to reduce body weight in 104 volunteers with overweight and type I obesity (BMI 25 - 34.9 kg/m2). This randomized, double-blind and placebo-controlled clinical trial has a 12-week intervention period, during which subjects have to take a daily dose of the product (probiotic or placebo). In this trial, anthropometric clinical data, the effect of the intervention on blood parameters and the composition of the intestinal microbiota will be analyzed.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 106 (actual)
- First submitted
- 4 Feb 2025
- Start date
- 12 Feb 2025
- Primary completion date
- 3 Jul 2025
- Lead sponsor
- Bioithas SL
- Diseases
- Obesity
- NCT number
- NCT06815926
What you commit to
- Study type: Interventional
- Participants enrolled: 106
- From 12 Feb 2025 to the primary completion date, 3 Jul 2025
- 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
- Subjects who have participated in a weight loss program or who have substantially modified their lifestyle habits (diet, physical exercise) during the previous 3 months.
- Treatment with antibiotics in the previous 4 weeks.
- Consumption of products or drugs intended for weight loss or satiety control, or that may influence weight in the previous 4 weeks.
- Consumption of products containing probiotics in the previous 2 months.
Other illness
- Subjects with diabetes (type I or II), hypothyroidism or other diseases that may promote weight gain.
- Presence of other serious pathologies, including cancer or autoimmune diseases, or any other that, at the medical discretion of the investigator, may influence the results of the study.
- Contraindication to taking the product under investigation, or allergy or intolerance to any of its ingredients.
Other
- In the case of women: pregnancy or breastfeeding, or plans to become pregnant during the course of the study.
Who the study is looking for
- Men and women aged ≥ 18 years.
- Body Mass Index (BMI) between 25.0 and 34.9 (overweight or obesity type I).
- Commitment to maintaining a lifestyle, including diet and sports habits, constant throughout the study.
- Signing of informed consent.
Age in the registry: 18 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 |
|---|---|---|---|
| MiBioPath Research Group (UCAM) Coordinator of this site? Confirm its status | Murcia | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.