Status:
COMPLETED
Intracolonic FODMAP Infusion in Healthy Volunteers
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
University of Auckland, New Zealand
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Irritable bowel syndrome (IBS) is one of the most common chronic diseases of the gut-brain axis. The underlying pathophysiology is multifactorial, poorly understood and differs between the subtypes: c...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Concomitant Kidney or Liver disease, Biliary obstruction
- Decreased cardiac -or respiratory function
- Pregnant or breastfeeding women
- Use of antibiotics in the past month
- History of skin allergies or a history of extreme sensitivity to cosmetics or lotions
- 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
- 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.
- 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)
Key Trial Info
Start Date :
June 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06488534
Start Date
June 26 2023
End Date
December 13 2024
Last Update
December 18 2025
Active Locations (1)
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1
KU Leuven
Leuven, Vlaams-Brabant, Belgium, 3000