Evaluation of the Colonization Capacity of a Probiotic Bacterium.

Obese Clinical Trial

— BIOPRED  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05878444
• Other study ID #: INNVA1/2021/32
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 1, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: May 2023
• Source: Valencian Innovation Agency
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: January 31, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Obese
• Weight, Body

Intervention

Dietary Supplement:
• Probiotic
Resistant gastrointestinal capsules will be provided daily to the participants.

Locations

Country	Name	City	State
Spain	Institute of Agrochemistry and Food Technology	Paterna	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Valencian Innovation Agency

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of our bacteria in feces	By specific PCR or by 16s sequencing	Before the end of 2023
Secondary	Adverse effect	Check if the probiotic is well tolerated. We will collect gastrointestinal symptoms and bristol scale.	Before the end of 2023