Intracolonic FODMAP Infusion in Healthy Volunteers

Ki vehet részt

• Subjects should provide written informed consent to participate in the study
• Women of child-bearing potential agree to apply a highly effective method of birth control during the entire duration of the trial. Highly effective birth control is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 years without spontaneous menses
• Subjects who are capable to understand the study and the questionnaires, and to comply with the study requirements
• Healthy volunteers should consider themselves healthy and should not be medically examined

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• Concomitant Kidney or Liver disease, Biliary obstruction
• Subject has received an investigational drug or used an investigational medical device within 30 days prior to randomization, or is currently enrolled in an investigational study
• History of major surgery of the gastrointestinal tract (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post-surgery are allowed)
• Known underlying organic gastrointestinal disease, including intestinal obstruction, ileus, intestinal perforation, severe inflammatory disorder like ulcerative colitis, Crohn's disease or toxic megacolon
• Diabetes mellitus types 1 and 2
• Decreased cardiac -or respiratory function
• History of skin allergies or a history of extreme sensitivity to cosmetics or lotions
• The use of following drugs 1 month prior to inclusion and during the whole study duration: laxatives, opioids, anti-acids, anticholinergics/antispasmodics, anticonvulsants, antidepressants, diuretics, antihypertensives, antipsychotics, calcium channel blockers, bile acid sequestrants, iron supplements, anticoagulants, HIV protease inhibitors (saquinavir, lopinavir), atorvastatine, negazodone, efavirenz, Sint-janskruid (CYP3A4 inducers)
• Pregnant or breastfeeding women
• Use of antibiotics in the past month
• Fragile skin vulnerable to skin tears
• Damaged epigastric skin (open wounds, rash, inflammation)
• Subjects who are unable to remain in a relaxed reclined position for the test duration