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

Last updated: December 20, 2023
Sponsor: University Hospital, Grenoble
Overall Status: Completed

Phase

N/A

Condition

Healthy Volunteers

Treatment

Innovative medical device for sampling small intestine content

Clinical Study ID

NCT05477069
38RC18.011
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

For the first time in the world, the objective of this study is to evaluate on healthy volunteers, an innovative medical device for the capture of intestinal liquid.This medical device is not yet CE marked.

Eligibility Criteria

Inclusion

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 96hours to 15 days max)
  • Having signed the informed and collection consent

Exclusion

Exclusion Criteria: Subject :

  • with medical treatment (except oral contraception and/or probiotics and relatedproducts)
  • 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 otherbiomedical 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 thefollowing treatments during the study: antidepressants, anxiolytics, antiparkinsonianagents, neuroleptics, antibiotics and prebiotics
  • who has taken during the previous 7 days: at least once a treatment for irritablebowel 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 fora long time
  • with gastric fullness
  • with known or suspected obstruction of the gastrointestinal tract (including knowninflammatory 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 WHOcriteria)
  • 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 HealthCode
  • absence of highly effective contraception for women with childbearing capacity untilthe end of the cycle following the end of participation in the trial

Study Design

Total Participants: 16
Treatment Group(s): 1
Primary Treatment: Innovative medical device for sampling small intestine content
Phase:
Study Start date:
October 24, 2022
Estimated Completion Date:
November 06, 2023

Study Description

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.

Connect with a study center

  • University Hospital Grenoble Alpes

    Grenoble, 38043
    France

    Site Not Available

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