Cognitive and Psychiatric Effects of Linaclotide on Patients With Constipation

NCT03342287 | Withdrawn

• 1 other identifier: 1088
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Constipation; Irritable Bowel Syndrome

Keywords

gut microbiome; anxiety; depression; cognition

Outcome Measures

Primary Outcomes (1)

• To measure anxiety and depression using the Depression, Anxiety and Stress Scale (DASS) in patients with IBS-C and CIC before and after treatment with Linaclotide

  Change from baseline to week 8

Secondary Outcomes (3)

• To measure neuropsychological performance in Patients with IBS-C and CIC using a standardized neuropsychological assessment in patients (CNS vital signs) before and after treatment with Linaclotide

  Change from baseline to week 8

• To determine changes in fecal microbiome profile before and after treatment with Linaclotide and whether these changes correlate with changes in psychiatric symptoms and cognition.

  Change from baseline to week 8

• To determine changes in inflammatory biomarker profile before and after treatment with Linaclotide and whether these changes correlate with changes in psychiatric symptoms and cognition.

  Change from baseline to week 8

Interventions

questionnaires OTHER

Questionnaires rating IBS symptoms, constipation, anxiety and depression

cognitive evaluation OTHER

Administration of online cognitive battery

Blood OTHER

Measurement of cytokines/inflammatory biomarkers

Fecal sample OTHER

Measurement of the gut microbiome

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with IBS-C or CIC starting on Linaclotide

You may qualify if:

• IBS-C or CIC as defined by Rome III criteria
• able to provide and sign informed consent
• age 18-65 years

You may not qualify if:

• Previous diagnosis of bipolar, schizophrenia, or schizoaffective disorder
• psychosis
• active suicidal thoughts
• presence of a major neurocognitive disorder, delirium or other cognitive disorder
• active substance dependence ( including the use of cannabis more than 3 times per week
• active eating disorder
• pregnant or breastfeeding

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University Medical Centre

Hamilton, Ontario, L8N3Z5, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and fecal samples collected.

MeSH Terms

Conditions

Constipation; Irritable Bowel Syndrome; Anxiety Disorders; Depression

Interventions

Surveys and Questionnaires; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Study Officials

• Paul Moayyedi, MD, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: November 14, 2017
• Study Start: March 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: March 1, 2021
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)