Status:
COMPLETED
The Effect of Serotonergic Modulation on Intestinal Permeability and Visceral Hypersensitivity in Healthy Individuals and Irritable Bowel Syndrome (IBS) Patients
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Top Institute Food and Nutrition
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Serotonin, 5-hydroxytryptamin (5-HT), plays an important role in regulating the gastrointestinal functions. In this study we will modulate the serotonin system with acute tryptophan depletion (ATD) an...
Eligibility Criteria
Inclusion
- IBS-patients
- Inclusion criteria:
- IBS will be diagnosed according to the Rome III criteria\* \[35\]:
- Recurrent abdominal pain or discomfort at least 3 days per month in the last 3 months associated with 2 or more of the following:
- Improvement with defecation
- Onset associated with a change in frequency of stool
- Onset associated with a change in form (appearance) of stool
- Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
- Discomfort means an uncomfortable sensation not described as pain. In pathophysiological research and clinical trails, a pain/discomfort frequency of at least 2 days a week during screening evaluation is an indication for subject's eligibility.
- Based on the medical history and previous examination, no other causes for the abdominal complaints can be defined.
- Age between 18 and 65 years
- Healthy individuals
- Inclusion criteria:
- All subjects will be screened with a standardized psychiatric examination using the mini international neuropsychiatric interview (MINI) to determine present psychiatric state. General psychological state will be assessed using the 17 item Hamilton depression rating scale (HAM-D17), the Dutch version of the symptom checklist (SCL-90) and the hospital anxiety and depression rating scale (HADS). The psychiatric evaluation will be carried out by a psychiatrist. Volunteers with deviating scores on any topic will be excluded from participation.
- Healthy individuals between age 18 and 65 years will be included in the study.
Exclusion
- Exclusion criteria for IBS patients:
- Severe co-morbidity hindering a rectal barostat procedure, according to the gastroenterologist's perception.
- Abdominal surgery, except for uncomplicated appendectomy, laparoscopic cholecystectomy or hysterectomy.
- Inability to stop medication that can influence gastrointestinal motility or perception (like loperamide, butylscopolamine, psylliumsead (metamucil), duspatal, metoclopramide, domperidon, erytromycine), or serotonin metabolism (carbidopa) for at least 3 days before tests.
- History of psychiatric disorders including use of psychoactive medication or psychological symptomatology, defined as a diagnosis on the MINI, HAM-D17 score above 18, global severity index score on SCL-90 for females ≥150, for males ≥131, or HADS scores ≥ 8. First-degree family members with psychiatric disorders
- Administration of investigational drugs in the 180 days prior to the study
- Premenstrual syndrome, dieting, pregnancy, lactation
- Excessive alcohol consumption (\>20 alcoholic consumption per week)
- Smoking
- Blood donation within 3 months before the study period
- Self-admitted HIV-positive state
- Irregular day-night rhythm
- Exclusion criteria for healthy individuals:
- History of gastrointestinal, psychiatric disorders including use of psychoactive medication or psychological symptomatology, defined as a diagnosis on the MINI, HAM-D17 score above 18, global severity index score on SCL-90 for females ≥150, for males ≥131, or HADS scores ≥ 8 First-degree family members with psychiatric disorders
- Use of medication, except oral contraceptives, within 14 days prior to testing
- Administration of investigational drugs in the 180 days prior to the study
- Previous abdominal surgery (other than uncomplicated appendectomy, laparoscopic cholecystectomy and hysterectomy)
- Premenstrual syndrome, dieting, pregnancy, lactation
- Excessive alcohol consumption (\>20 alcoholic consumption per week)
- Smoking
- Blood donation within 3 months before the study period
- Self-admitted HIV-positive state
- Irregular day-night rhythm
- Severe co-morbidity hindering a rectal barostat procedure, according to the gastroenterologist's perception.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00731003
Start Date
April 1 2009
End Date
May 1 2011
Last Update
November 13 2014
Active Locations (1)
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1
Maastricht University Medical Center+
Maastricht, Limburg, Netherlands, 6200AZ