Evaluation of the Colonization Capacity of a Probiotic Bacterium.

Phase 1

Not yet recruiting

• Conditions: Weight, Body; Obese
• Interventions: Dietary Supplement: Probiotic

• Registration Number: NCT05878444
• Lead Sponsor: Valencian Innovation Agency

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.

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-17
• Study First Submitted QC: 2023-05-25
• Last Update Submitted: 2023-05-25
• Study First Posted: 2023-05-26
• Last Update Posted: 2023-05-26
• Study Start: 2023-06-01
• Primary Completion: 2023-09-30
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal weight	Probiotic	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.
Overweight/Obese	Probiotic	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.

Primary Outcome Measures

Name	Time	Method
Presence of our bacteria in feces	Before the end of 2023	By specific PCR or by 16s sequencing

Secondary Outcome Measures

Name	Time	Method
Adverse effect	Before the end of 2023	Check if the probiotic is well tolerated. We will collect gastrointestinal symptoms and bristol scale.

Trial Locations

Locations (1)

Institute of Agrochemistry and Food Technology; 🇪🇸 Paterna, Valencia, Spain