Evaluation of the Colonization Capacity of a Probiotic Bacterium. (BIOPRED)

Valencian Innovation Agency

Status and phase: Not yet enrolling; Phase 1

Conditions: Obese; Weight, Body

Treatments: Dietary Supplement: Probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT05878444

INNVA1/2021/32

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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15 participants in 2 patient groups

Normal weight

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Probiotic

Overweight/Obese

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Probiotic