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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05878444
Other study ID # INNVA1/2021/32
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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