The Effect of Serotonergic Modulation on Intestinal Permeability and Visceral Hypersensitivity in Healthy Individuals and Irritable Bowel Syndrome (IBS) Patients
NCT ID: NCT00731003
Last Updated: 2014-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2009-04-30
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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I
ATD procedure
Acute tryptophan depletion
Acute tryptophan depletion employs the oral ingestion of an amino acid mixture devoid of tryptophan, the precursor of serotonin, which results in lowered serotonin levels.
II
Oxitriptan
Oxitriptan
100 mg 5-Hydroxytryptophan will be administered orally.
III
Amino acid mixture with tryptophan
Amino acid drink with tryptophan
Amino acid drink with tryptophan, placebo for the ATD procedure
IV
Placebo capsule
Placebo capsule
Placebo for 5-HTP
Interventions
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Oxitriptan
100 mg 5-Hydroxytryptophan will be administered orally.
Acute tryptophan depletion
Acute tryptophan depletion employs the oral ingestion of an amino acid mixture devoid of tryptophan, the precursor of serotonin, which results in lowered serotonin levels.
Amino acid drink with tryptophan
Amino acid drink with tryptophan, placebo for the ATD procedure
Placebo capsule
Placebo for 5-HTP
Eligibility Criteria
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Inclusion Criteria
1. 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.
2. Based on the medical history and previous examination, no other causes for the abdominal complaints can be defined.
3. Age between 18 and 65 years
Healthy individuals
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 Criteria
2. Abdominal surgery, except for uncomplicated appendectomy, laparoscopic cholecystectomy or hysterectomy.
3. 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.
4. 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
5. Administration of investigational drugs in the 180 days prior to the study
6. Premenstrual syndrome, dieting, pregnancy, lactation
7. Excessive alcohol consumption (\>20 alcoholic consumption per week)
8. Smoking
9. Blood donation within 3 months before the study period
10. Self-admitted HIV-positive state
11. Irregular day-night rhythm
1. 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
2. Use of medication, except oral contraceptives, within 14 days prior to testing
3. Administration of investigational drugs in the 180 days prior to the study
4. Previous abdominal surgery (other than uncomplicated appendectomy, laparoscopic cholecystectomy and hysterectomy)
5. Premenstrual syndrome, dieting, pregnancy, lactation
6. Excessive alcohol consumption (\>20 alcoholic consumption per week)
7. Smoking
8. Blood donation within 3 months before the study period
9. Self-admitted HIV-positive state
10. Irregular day-night rhythm
11. Severe co-morbidity hindering a rectal barostat procedure, according to the gastroenterologist's perception.
18 Years
65 Years
ALL
Yes
Sponsors
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Top Institute Food and Nutrition
OTHER
Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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A AM Masclee, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Hospital
F Troost, PhD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University
Locations
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Maastricht University Medical Center+
Maastricht, Limburg, Netherlands
Countries
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References
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Keszthelyi D, Troost FJ, Jonkers DM, van Eijk HM, Lindsey PJ, Dekker J, Buurman WA, Masclee AA. Serotonergic reinforcement of intestinal barrier function is impaired in irritable bowel syndrome. Aliment Pharmacol Ther. 2014 Aug;40(4):392-402. doi: 10.1111/apt.12842. Epub 2014 Jun 18.
Keszthelyi D, Troost FJ, Jonkers DM, Kruimel JW, Leue C, Masclee AA. Decreased levels of kynurenic acid in the intestinal mucosa of IBS patients: relation to serotonin and psychological state. J Psychosom Res. 2013 Jun;74(6):501-4. doi: 10.1016/j.jpsychores.2013.01.008. Epub 2013 Feb 15.
Keszthelyi D, Troost FJ, Jonkers DM, van Donkelaar EL, Dekker J, Buurman WA, Masclee AA. Does acute tryptophan depletion affect peripheral serotonin metabolism in the intestine? Am J Clin Nutr. 2012 Mar;95(3):603-8. doi: 10.3945/ajcn.111.028589. Epub 2012 Feb 1.
Other Identifiers
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MEC 08-2-070
Identifier Type: -
Identifier Source: org_study_id