Phase
Condition
Healthy Volunteers
Treatment
Innovative medical device for sampling small intestine content
Clinical Study ID
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 96 hours 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,antiparkinsonian agents, 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 drugsfor a 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
Study Description
Connect with a study center
University Hospital Grenoble Alpes
Grenoble, 38043
FranceSite Not Available

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