Feasibility Study of an Innovative Medical Device for Sampling the Contents of the Small Intestine.

This medical device consists of a standard pill made of 3 capsules for the collection of intestinal microbiota. The pill is ingested by the volunteer and multi-omics analysis will be performed on intestinal fluid samples from the capsules and also on faeces.

First in man, involving a medical device, prospective, monocentric, not randomized, not controlled and open-label study.

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