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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obese; Weight, Body
• Intervention / Treatment: Dietary supplement: Probiotic

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 Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• Spain
  • Valencia
    • Paterna, Valencia, Spain, 46980
      • Institute of Agrochemistry and Food Technology
      • Contact: Yolanda Sanz Herranz, Pharmacist; Phone Number: 435240 +34 963 900 022; Email: yolsanz@iata.csic.es
      • Contact: María Tamayo García, Nutritionist; Phone Number: 435234 +34 963 900 022; Email: mtamayo@iata.csic.es
      • Principal Investigator: Yolanda Sanz Herranz, Pharmacist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normal weight; 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; Resistant gastrointestinal capsules will be provided daily to the participants.
Experimental: Overweight/Obese; 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; Resistant gastrointestinal capsules will be provided daily to the participants.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Valencian Innovation Agency

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2023
• Primary Completion (Estimated): September 30, 2023
• Study Completion (Estimated): January 31, 2024

Study Registration Dates

• First Submitted: May 17, 2023
• First Submitted That Met QC Criteria: May 25, 2023
• First Posted (Actual): May 26, 2023

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Microbiota; probiotic; Obese; Colonization
• Additional Relevant MeSH Terms: Body Weight
• Other Study ID Numbers: INNVA1/2021/32

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: confidentiality and protection of personal data law

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No