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Cognitive and Psychiatric Effects of Linaclotide on Patients With Constipation

NCT03342287 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2021-08-31

No results posted yet for this study

Summary

Irritable Bowel syndrome - constipation predominant (IBS-C) is a chronic and disabling,disorder of the gut that is characterized by abdominal pain or discomfort. Approximately 50% of patients with IBS-C will also meet criteria for anxiety or depression.

Anti depressant medication is widely used in the treatment of IBS. Linaclotide is a novel medication for IBS that is also effective at relieving pain associated with IBS, which may be in part to signalling between the gut and the brain. However, the impact of Linaclotide on the psychiatric symptoms of anxiety and depression on IBS has not been investigated.

Conditions

Interventions

OTHER

questionnaires

Questionnaires rating IBS symptoms, constipation, anxiety and depression

OTHER

cognitive evaluation

Administration of online cognitive battery

OTHER

Blood

Measurement of cytokines/inflammatory biomarkers

OTHER

Fecal sample

Measurement of the gut microbiome

Sponsors & Collaborators

Principal Investigators

  • Paul Moayyedi, MD, PhD · McMaster University

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2020-12-31
Completion
2021-03-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT03342287 on ClinicalTrials.gov