Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-24 @ 7:07 PM
NCT ID:
NCT07165457
Eligibility Criteria:
Inclusion Criteria:
* Healthy men and women aged between 18 and 70 years.
* Stable body weight (±5%) during the three months prior to study initiation.
* Physical examination and vital signs within normal limits or clinically irrelevant for the study.
* Subjects must be able to understand and willing to sign the informed consent form, and comply with all study procedures and requirements.
* Ongoing pharmacological/hormonal treatment will be permitted provided it does not affect the parameters under investigation and the dosage has been stable for at least three months prior to study initiation.
* Willingness to undergo all study procedures, including daily consumption of one probiotic capsule during the intervention.
* Availability in terms of time and location to attend the two scheduled in-person clinical evaluation sessions.
Exclusion Criteria:
* Volunteers undergoing pharmacological treatment with unstable dosing (less than 3 months prior to study initiation) will be excluded, particularly if treatments:
* Affect gastrointestinal function.
* Include chronically prescribed stomach protectants.
* Subjects with significant functional or structural abnormalities of the digestive system, such as malformations, angiodysplasias, active peptic ulcers, chronic inflammatory or malabsorption diseases, hiatal hernia, chronic reflux, etc.
* Subjects who have undergone surgical procedures resulting in permanent alterations of the digestive system (e.g., gastroduodenostomy) or bariatric surgery.
* Presence of systemic intestinal, hepatic, or renal diseases, such as uncontrolled thyroid disorders, cirrhosis, inflammatory bowel disease, untreated anemia, etc. (non-alcoholic fatty liver disease will not be excluded).
* Alcohol consumption exceeding the sex-specific limits (\>14 units/week for women, \>20 units/week for men).
* Pregnancy, lactation, or plans to become pregnant during the study period.
* Use of nutritional supplements that may affect study outcomes (e.g., weight-loss supplements, newly initiated fiber supplements, probiotics, postbiotics, etc.).
* Subjects with any type of cancer currently undergoing treatment, or with less than five years since cancer remission.
* Known allergy to any component of the investigational product.
* Presence of cognitive and/or psychological impairments.
* Anticipated poor compliance or, in the investigator's opinion, difficulty adhering to study procedures.
* Participation in any weight loss or body composition modification treatments.
* Use of antibiotics within 15 days prior to the baseline visit.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07165457
Study Brief:
Protocol Section:
NCT07165457