An Assessment of Cognitive Function in Irritable Bowel Syndrome

NCT01304355 | Unknown DMC

• 1 other identifier: APC024-GC/ANMS
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 2

Brief Summary

Irritable bowel syndrome (IBS) is a common disorder affecting up to 20% of the general population. Despite the prevalence of the disorder, it remains poorly understood. This is reflected in a symptom based diagnostic scheme, the lack of a suitable biological marker and inadequate treatment options. Current knowledge suggests the disorder is as a result of a dysregulated brain-gut axis, a complex construct describing the bidirectional communication systems underpinning normal gastrointestinal functioning. The investigators hypothesize here that the disruption of this brain-gut axis is facilitated by an increased degradation of tryptophan along the kynurenine pathway. This metabolic abnormality has the potential to impact on both GI and CNS signaling through its effects on serotonergic signaling and the impact of metabolites like kynurenic acid and quinolinic acid on cognitive processes respectively. Previous data from our laboratory indicated increased tryptophan degradation in IBS patients and suggested the metabolites produced as putative biological markers of the condition. In this study the investigators aim to reconcile cognitive impairment in IBS with GI and CNS symptom severity and kynurenine pathway metabolites. The investigators will establish these baseline measures in IBS compared to control subjects. A battery of cognitive assessments will be carried out using a computerized testing system. Standardized rating scales will be used to assess GI and CNS symptom severity. GC-MS/MS, a recently acquired technology platform in our laboratory, will be used to quantify plasma quinolinic acid levels.

Conditions

Irritable Bowel Syndrome

Keywords

IBS; Cognition; Kynurenine Pathway; Gastrointestinal

Outcome Measures

Primary Outcomes (6)

• CANTAB Assessments

  Cognitive assessments using CANTAB, a computerised cognitive assessment package

  Baseline

• IBS Symptom Severity

  As assessment of IBS symptom severity using validated questionnaires

  Baseline

• Kynurenine Pathway Metabolies

  Plasma tryptophan, kynurenine, kynurenic acid, quinolinic acid

  Baseline

• Glucocorticoids

  Plasma/Salivary Cortisol

  Baseline

• Cytokines

  Plasma Cytokine concentrations

  Baseline

• Psychiatric Comorbidity

  Psychiatric comorbidity will be assessed according to DSM-IV criteria

  Baseline

Secondary Outcomes (1)

• Sleep Quality

  Baseline

Study Arms (2)

Controls

Healthy Control Subjects

IBS Group

Subjects diagnosed with IBS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

IBS Patients will be recruited from a university database of IBS patients, comprising people who have previously either attended gastroenterology clinics at Cork University Hospital or responded to direct advertisement regarding participation in IBS research. Healthy Controls will be recruited from responders to a direct advertisement regarding participation in IBS research

You may qualify if:

• Be able to give written informed consent,
• Be between the ages of 18 and 65 years of age,
• Must be female,
• IBS patients must have a confirmed clinical diagnosis IBS using Rome III criteria
• Healthy subjects must be in generally good health as determined by the investigator
• Pregnant women
• Individuals with known lactose intolerance or immunodeficiency will be excluded

You may not qualify if:

• Are less than 18 and greater than 65 years of age,
• Have a significant acute or chronic coexisting illness \[cardiovascular, gastrointestinal, immunological, or any condition which contraindicates, in the investigators judgement, entry to the study\].
• Having a condition or taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results; to include, anti-psychotics and steroids (in healthy and IBS subjects).
• Have evidence of immunodeficiency; bleeding disorder or coagulopathy.
• Subjects may not be receiving treatment involving experimental drugs. If the subject has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study.

Sponsors & Collaborators

• University College Cork: lead
• Science Foundation Ireland: collaborator
• American Neurogastroenterology and Motility Society: collaborator

Study Sites (2)

Cork University Hospial

Cork, Cork, Ireland

RECRUITING

University College Cork

Cork, Cork, Ireland

RECRUITING

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Biospecimen

Retention: SAMPLES WITH DNA

Plasma Serum Saliva

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Gerard Clarke, PhD

  University College Cork

  PRINCIPAL INVESTIGATOR

• Timothy G Dinan, Professor

  University College Cork

  PRINCIPAL INVESTIGATOR

• John F Cryan, PhD

  University College Cork

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerard Clarke, PhD

CONTACT

003535214901415; g.clarke@ucc.ie

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 24, 2011
• First Posted: February 25, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: February 25, 2011

Record last verified: 2011-02

Locations

IE (2)