Clinical trial NCT05878444: Evaluation of the Colonization Capacity of a Probiotic Bacterium.
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Obese
Weight, Body
Keywords: probiotic
Obese
Colonization
Microbiota
Lead sponsor: Valencian Innovation Agency
Sponsor class: OTHER_GOV
First posted: 2023-05-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will try the probiotic in normal weight and overweight/obese people
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of our bacteria in feces
timeFrame: Before the end of 2023
Secondary outcomes:
measure: Adverse effect
timeFrame: Before the end of 2023
Other outcomes:
Locations:
city: Paterna
country: Spain
facility: Institute of Agrochemistry and Food Technology
state: Valencia
Study officials:
References: