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

Primary Purpose

Obese, Weight, Body

Status
Not yet recruiting
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Probiotic
Sponsored by
Valencian Innovation Agency
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obese focused on measuring probiotic, Obese, Colonization, Microbiota

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Institute of Agrochemistry and Food Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Normal weight

Overweight/Obese

Arm 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.

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.

Outcomes

Primary Outcome Measures

Presence of our bacteria in feces
By specific PCR or by 16s sequencing

Secondary Outcome Measures

Adverse effect
Check if the probiotic is well tolerated. We will collect gastrointestinal symptoms and bristol scale.

Full Information

First Posted
May 17, 2023
Last Updated
May 25, 2023
Sponsor
Valencian Innovation Agency
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1. Study Identification

Unique Protocol Identification Number
NCT05878444
Brief Title
Evaluation of the Colonization Capacity of a Probiotic Bacterium.
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Valencian Innovation Agency

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obese, Weight, Body
Keywords
probiotic, Obese, Colonization, Microbiota

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
We will try the probiotic in normal weight and overweight/obese people
Masking
Outcomes Assessor
Masking Description
Samples will be coded and they will not know the pacient personal/sociodemographic data.
Allocation
Non-Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Normal weight
Arm Type
Experimental
Arm 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.
Arm Title
Overweight/Obese
Arm Type
Experimental
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
Resistant gastrointestinal capsules will be provided daily to the participants.
Primary Outcome Measure Information:
Title
Presence of our bacteria in feces
Description
By specific PCR or by 16s sequencing
Time Frame
Before the end of 2023
Secondary Outcome Measure Information:
Title
Adverse effect
Description
Check if the probiotic is well tolerated. We will collect gastrointestinal symptoms and bristol scale.
Time Frame
Before the end of 2023

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Institute of Agrochemistry and Food Technology
City
Paterna
State/Province
Valencia
ZIP/Postal Code
46980
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yolanda Sanz Herranz, Pharmacist
Phone
+34 963 900 022
Ext
435240
Email
yolsanz@iata.csic.es
First Name & Middle Initial & Last Name & Degree
María Tamayo García, Nutritionist
Phone
+34 963 900 022
Ext
435234
Email
mtamayo@iata.csic.es
First Name & Middle Initial & Last Name & Degree
Yolanda Sanz Herranz, Pharmacist

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
confidentiality and protection of personal data law

Learn more about this trial

Evaluation of the Colonization Capacity of a Probiotic Bacterium.

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