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
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
Connect with a study center
University Hospital Grenoble Alpes
Grenoble, 38043
FranceSite Not Available
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