Evaluation of the Colonization Capacity of a Probiotic Bacterium.

Study Overview
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Brief Summary
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The goal of this interventional study is to test the colonization of a new generation probiotic in normal weight and overweight/obese people. The main question aims to answer is if our bacteria is able to colonize the human intestine. Participants will recieve a probiotic pill every day during 15 consecutive days and fill in questionaries.

Detailed Description
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Normal weight and overweight volunteers will be recruited to evaluate the colonization capacity of the bacteria. In this case, stool samples will be taken before starting the intervention (T0), after the treatment (T1) and a week after fiinishing the administration of the probiotic (T2). All the subjects will receive the probiotic supplement in capsules taken daily, 7-8 normal weight subjects will take a concentration of 10^9-10 CFU and 7-8 overweight subjects will take a concentration of 10^9-10 CFU.

Official Title
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Evaluate the Colonization Capacity of a New Generation Probiotic Within the Project: Valorization of an Intestinal Bacterium as a Functional Ingredient to Prevent the Development of Metabolic Syndrome and Diabetes -BIOPRED

Conditions
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Weight, Body, Obese

Intervention / Treatment
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* Dietary Supplement: Probiotic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 65 years. Body mass index between 20-25 kg/m2 for normopese subjects and BMI 25-30 kg/m2 for overweight participants. Body weight and eating habits stable in the last three months before the first visit. Willingness to participate in the intervention study, giving their data and samples. Signature and acceptance of the informed consent. Exclusion Criteria: Preexistence of other physical conditions (food allergy/sensitivity, gastrointestinal conditions [such as inflammatory bowel disease, celiac disease, pancreatitis, chronic constipation, etc.], immunodeficiency) Eating disorders Use of antibiotics one month prior to the first visit Chronic use of medications (antacids, antidiabetics, anti-hypertensives, etc.) History or current abuse of drugs or alcohol Following a vegetarian, vegan, or other restrictive diet Any other reason deemed appropriate for exclusion at the clinician's discretion Non-compliance with adherence to treatment regimen Direct association with research and/or investigators

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We will try the probiotic in normal weight and overweight/obese people
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal weight<br>People with BMI between 20-25 will be enrolled in this group. They will take the probiotic capsule daily during 15 days. Dosis will be 10^9-10. | Dietary Supplement: Probiotic<br>* Resistant gastrointestinal capsules will be provided daily to the participants.<br>|
| Experimental: Overweight/Obese<br>People with BMI >25 will be enrolled in this group. They will take the probiotic capsule daily during 15 days. Dosis will be 10^9-10. | Dietary Supplement: Probiotic<br>* Resistant gastrointestinal capsules will be provided daily to the participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of our bacteria in feces | By specific PCR or by 16s sequencing | Before the end of 2023 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effect | Check if the probiotic is well tolerated. We will collect gastrointestinal symptoms and bristol scale. | Before the end of 2023 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotic, Obese, Colonization, Microbiota