An observational study in Constipation and Irritable Bowel Syndrome, sponsored by McMaster University. Withdrawn at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-08-31.
Sponsored by McMaster University · Observational
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Among 50 studies in Constipation with a site in Canada — 5 open to participants now, 5 under way, 1 of them phase 3. Constipation · Canada.
Among the 50 studies in Constipation with a site in Canada, this one is the only one that started in 2016, is one of 2 observational ones, and was the 35th registered.
1,047 studies on the registry are indexed under Constipation; 161 are open to participants now.
Browse Constipation studies →5 of the 50 studies in Constipation with a site in Canada are open now. Recruiting first, the newest first:
Eli Lilly and Company · Sites in Canada, United States, Belgium and 5 more countries
Ages 18–75
Laval University · Sites in Canada
Ages 18+ · Women only
McMaster University · Sites in Canada
Ages 6–70
Nexira · Sites in Canada
Ages 30–60 · Healthy volunteers
Hamilton Health Sciences Corporation · Sites in Canada
Ages 4–17
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 99 Constipation studies recruiting now, 32 (32%) set no upper age limit and 52 (53%) stop at 75 or younger; 17 take children under 18; 28 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
50 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 15 · Phase 3 22 · Phase 4 3
First in 1996; this study’s year is marked. 1 started in 2016.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 227 across the 48 interventional studies, 267 across the 2 observational. Of the 44 that completed or were terminated, 22 (50%) have results posted.
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35 of 50 have an industry lead sponsor. The 10 most frequent:
McMaster University is the lead sponsor of 741 studies on the registry; 127 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
McMaster University has 2 studies filed under Constipation — fewer than ten, so there is no comparison to draw.
3 of the studies in Constipation with a site in Canada that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06836024Phase 3Hamilton Health Sciences CorporationA Trial of Actazin Versus PEG 3350 for Maintenance Therapy in Children With Constipation | 2026-12-30 |
| NCT07703254NexiraA Clinical Trial to Investigate the Efficacy of Acacia Fiber on Gastrointestinal Health and Microbiota Composition in Healthy Adults With Occasional Constipation | 2026-12 |
| NCT07545772Eli Lilly and CompanyA Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C) | 2027-07 |
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Among the 50 studies in Constipation with a site in Canada, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Irritable bowel syndrome (IBS) is a chronic, disabling functional gastrointestinal disorder that is characterized by abdominal pain or discomfort and a disturbance in bowel habit. It has long been recognized that psychological factors can be important in IBS, and that bi-directional signaling between the gut and the brain is likely involved in the pathophysiology of the syndrome. Approximately 50% of patients with IBS at a tertiary center will also meet criteria for anxiety or depression. Anti-depressant medications are widely used in the treatment of IBS, even without psychiatric comorbidity, with good evidence for both tricyclic antidepressants and selective serotonin reuptake inhibitors. Unfortunately both classes of anti-depressants have significant gastrointestinal side effects and a large number of patients cannot tolerate the medications.
Linaclotide, a guanylate cyclase agonist, has emerged as an important, novel treatment for patients with constipation-predominant IBS (IBS-C) and Chronic Idiopathic Constipation (CIC). Linaclotide is effective at relieving pain associated with IBS, which may be in part mediated by modulation of signaling between the gut and the brain. In this study the investigators will study the effect of Linaclotide on anxiety, depression and cognitive functioning in patients with IBS-C and CIC. If Linaclotide is also effective in treating anxiety and depression and improving cognitive functioning in patients with IBS-C and CIC, this will be an important therapeutic advance for the 50% of IBS patients with psychiatric comorbidity.
The investigators also propose to investigate the mechanisms by which Linaclotide may effect psychiatric symptoms and neuropsychological functioning by measuring changes in the gut microbiome and inflammatory biomarkers. The gut and the brain are intimately connected by several, bidirectional, signaling pathways including neural, humoral and immune mechanisms. The concept of the "gut-brain axis" has recently been supplanted by the "microbiota-gut-brain axis," emphasizing the important role the gut microbiota plays in mediating brain responses. The gut microbiota communicate with the brain through immune and neuronal pathways and some microbiota can directly secrete neurotransmitters such as serotonin, dopamine and gamma-aminobutyric acid (GABA) . In true bidirectional fashion, the brain can also influence the microbiota through the secretion of cortisol and sympathetic neurotransmission, changing gut motility, secretion and mucin production, which can affect the habitat of the resident microbiota and thereby alter the composition of the microbiota. Alterations in gut microbiota have been associated with irritable bowel syndrome in multiple studies.
Given the importance of the gut microbiota in mediating gut-brain responses, the investigators propose that the gut microbiota may play a direct role in the pathophysiology of anxiety and depression in patients with IBS. If Linaclotide is effective in reducing psychiatric and neuropsychological symptoms in patients with IBS, this may occur through changes in the gut microbiota, perhaps as a result of altered colonic motility and altered habitat of resident microbiota.
Patients with IBS-C or CIC starting on Linaclotide
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Questionnaires rating IBS symptoms, constipation, anxiety and depression
Administration of online cognitive battery
Measurement of cytokines/inflammatory biomarkers
Measurement of the gut microbiome
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
Time frame: Change from baseline to week 8
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
Neuropsychological testing will be performed using the standardized and validated CNS vital signs evaluation platform.
Time frame: 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.
Fecal microbiome profile will be characterized using our in-house bioinformatics pipelines that provide measures of diversity between time points as well as differences in taxa between time points. Measurements will be aggregated to arrive at one reported value including diversity measures for microbiome analysis.
Time frame: 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.
Inflammatory biomarkers measured will include IL-1, IL-6, TNF-alpha, IFN-gamma. Measurements will be aggregated to arrive at one reported value for average inflammatory biomarker levels.
Time frame: Change from baseline to week 8
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Mar 2016, a primary completion of Dec 2020 and a completion of Mar 2021. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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