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 @ 11:07 PM
Ignite Modification Date:
2025-12-24 @ 11:07 PM
NCT ID:
NCT05477069
Eligibility Criteria:
Inclusion Criteria:
* Able to understand the study and the associated instructions
* Aged ≥18 years and ≤65 years
* Fasting with water and food for at least 10 hours
* BMI between ≥20 and ≤30 kg/m².
* Transit evaluated at 1 to 3 bowel movements/day
* Maintain regular physical activity and eating habits for the duration of the study
* Affiliated with a social security plan
* Have a freezer in their home and at work, if applicable
* Volunteer staying in the Isère department during the collection of the faeces (from 96 hours to 15 days max)
* Having signed the informed and collection consent
Exclusion Criteria:
Subject :
* with medical treatment (except oral contraception and/or probiotics and related products)
* with lactose and fructose intolerance
* with of gastroparesis
* who had a colonoscopy preparation up to 1 month prior to inclusion
* in the exclusion period of another clinical investigation,
* who receive more than 4500 euros of compensation due to his participation in other biomedical research in the 12 months preceding this study
* who cannot be contacted in case of emergency
* who has taken during the 15 days prior to inclusion and/or is scheduled to take the following treatments during the study: antidepressants, anxiolytics, antiparkinsonian agents, neuroleptics, antibiotics and prebiotics
* who has taken during the previous 7 days: at least once a treatment for irritable bowel syndrome (antispasmodics,..) or for constipation (laxative) or for diarrhea
* with a known food allergy
* who have to undergo colon surgery
* with intestinal obstruction history
* with hepatic, cardiac, congenital or renal comorbidity
* with long-standing diabetes
* with an inflammatory disease of the digestive tract, a history of digestive surgery
* who have been treated with radiotherapy or who have taken anti-inflammatory drugs for a long time
* with gastric fullness
* with known or suspected obstruction of the gastrointestinal tract (including known inflammatory bowel or intestinal diverticula)
* with presence of swallowing disorders or Zencker's diverticulum
* with nausea, deviated nasal septum
* with contraindications to esophageal tube placement (chronic esophageal pathology)
* drug or alcohol abuse (3 units for men and 2 units for women according to WHO criteria)
* with a known allergy to silicone or to iodine
* refusing medical imaging or surgery (in case of non-recovery of the capsule)
* protected person concerned by the articles L1121-5 to L1121-8 of the Public Health Code
* absence of highly effective contraception for women with childbearing capacity until the end of the cycle following the end of participation in the trial
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05477069
Study Brief:
Protocol Section:
NCT05477069