Evaluation of the Colonization Capacity of a Probiotic Bacterium.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

EXploratory Study on Postprandial Energy Metabolism

NCT06786052

Obesity and Overweight Moderately Obese

RECRUITING PHASE2

Use of a Novel Synbiotic to Change Human Gut Bacteria and Improve Health in Obese Adults

NCT02355210

Intestinal Microbiota and Barrier Function

COMPLETED NA

Effects of Probiotics on Metabolic Syndrome ,Intestinal Microflora and SCFA.

NCT06183801

Metabolic Syndrome

COMPLETED NA

Effect of Synbiotic L. Fermentum Strains on Body Fat Mass

NCT05405205

Weight, Body

UNKNOWN NA

Prospective Tolerability Assessment of a Probiotic Dietary Supplement

NCT04044144

Healthy Adults

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obese Weight, Body

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

We will try the probiotic in normal weight and overweight/obese people

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Samples will be coded and they will not know the pacient personal/sociodemographic data.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Probiotic

Intervention Type DIETARY_SUPPLEMENT

Resistant gastrointestinal capsules will be provided daily to the participants.

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.

Group Type EXPERIMENTAL

Probiotic

Intervention Type DIETARY_SUPPLEMENT

Resistant gastrointestinal capsules will be provided daily to the participants.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Probiotic

Resistant gastrointestinal capsules will be provided daily to the participants.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes