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The Effect of Serotonergic Modulation on Intestinal Permeability and Visceral Hypersensitivity in Healthy Individuals and Irritable Bowel Syndrome (IBS) Patients

NCT00731003 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-11-13

No results posted yet for this study

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) and administration of 5-hydroxytryptophan (5-HTP). ATD is based on ingestion of an amino acid drink devoid of the precursor of serotonin and hence caused a decreased serotonin level. 5-hydroxy-tryptophan is the direct precursor of serotonin and its administration, an increased serotonin level is expected. During these interventions, gut permeability and visceral sensitivity will be measured in healthy individuals and patients with irritable bowel syndrome, which is characterized by altered permeability and visceral hypersensitivity.

Conditions

  • Irritable Bowel Syndrome

Interventions

DRUG

Oxitriptan

100 mg 5-Hydroxytryptophan will be administered orally.

OTHER

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.

OTHER

Amino acid drink with tryptophan

Amino acid drink with tryptophan, placebo for the ATD procedure

DRUG

Placebo capsule

Placebo for 5-HTP

Sponsors & Collaborators

  • Top Institute Food and Nutrition

    collaborator OTHER

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • A AM Masclee, Prof. Dr. · Maastricht University Hospital

  • F Troost, PhD · Maastricht University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00731003 on ClinicalTrials.gov