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:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT05367427
Eligibility Criteria:
Inclusion Criteria:
* Subjects who obtain a score between 13 and 39 points with diarrhea predominance in the Gastrointestinal Symptoms Rating Scale (GSRS-IBS) corresponding to the last week.
* Men and women between 18 and 65 years old.
* Absence of a family or social environment that prevents compliance with treatment.
* Adequate cultural level and understanding of the clinical study.
* Agree to voluntarily participate in the study and give their informed consent in writing.
Exclusion Criteria:
* Subjects with BMI \<18.5 or \>35 kg/m2.
* Subjects who have participated in programs and/or clinical trials and who have lost or gained more than 4 kg in the last 3 months.
* Subjects diagnosed with Diabetes Mellitus 1 or 2.
* Subjects diagnosed with metabolic syndrome, hypothyroidism and/or hyperthyroidism.
* Subjects with allergies to the excipients of the product/placebo.
* Subjects with an established diagnosis of eating behavior disorder.
* Women who do not agree to continue with their contraceptive method during the study period.
* Subjects who perform excessive physical exercise (\>2 h more than 3 times per week).
* Subjects who wish to start an exercise plan and/or dietary program during the study period.
* Subjects with serious diseases (liver disease, kidney disease, heart disease, lung disease, cancer, etc.).
* Subjects with chronic intestinal pathologies (gastritis, ulcerative colitis, irritable bowel syndrome, inflammatory bowel disease, Crohn's disease, intestinal perforation, history of gastroparesis, etc.).
* Subjects with autoimmune diseases and/or subjects undergoing treatment with corticosteroids, immunosuppressants and/or biologicals in the last 12 months.
* Subjects with major surgeries in the last 3 months or gastrointestinal surgery in the last 6 months.
* Subjects with weight loss surgery (gastric bypass, lap band)
* Subjects under treatment with oral antibiotics during the 30 days prior to the start of the study.
* Subjects with recent episodes of acute gastrointestinal illness such as nausea, vomiting or acute gastroenteritis 2 weeks before the start of the study.
* Subjects who wish to quit smoking during the duration of the study.
* Subjects who consume antioxidant supplements, omega 3 supplements, vitamins, minerals, prebiotic, synbiotic, parabiotic or probiotic products in the 4 weeks prior to the start of the study and who do not agree to suppress their consumption during the study period.
* Subjects with alcohol consumption greater than 30 g/day (equivalent to 300 ml of wine, about 3 beers or a glass (75 ml) of whisky, cognac, anise, etc.)).
* Subjects with regular use of antidiarrheal medications (\>2 per week) during the last 3 months prior to the start of the study.
* Subjects on anticoagulant therapy.
* Subjects with dementia, mental illness, or decreased cognitive function.
* Pregnant or lactating women.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05367427
Study Brief:
Protocol Section:
NCT05367427