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Factors Affecting Dissatisfaction to Treatments in Patients With Chronic Constipation and IBS With Constipation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02813616
Recruitment Status : Completed
First Posted : June 27, 2016
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Guido Basilisco, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief Summary:
Chronic constipation (CC) and Irritable Bowel Syndrome with Constipation (IBS-C) are two conditions difficult to manage because factors affecting dissatisfaction to treatments are misleading. This observational multicentric national study is aimed to assess which factors are related with a clinically significant improvement in patients with CC and IBS-C. Patients will be evaluated at baseline and after every one-month "standard of care" therapy with standardised questionnaires to assess bowel habit and satisfaction to treatments. Somatisation, quality of life, colonic transit time and resting anal pressure will be assessed at baseline.

Condition or disease
Constipation Irritable Bowel Syndrome

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 78 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Factors Affecting Dissatisfaction to Treatments in Patients With Chronic Constipation and Irritable Bowel Syndrome With Constipation. Pooled Analysis of Multiple Prospective N-of-1 Treatment Optimization Trials
Actual Study Start Date : February 2016
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation




Primary Outcome Measures :
  1. Number of patients achieving a sustained improvement [ Time Frame: 2 months ]
    Sustained improvement is defined as a satisfaction score > 4 on a 7 point visual analogue scale for 2 consecutive months with the same treatment regimen.


Secondary Outcome Measures :
  1. Factors associated with sustained improvement: Gender [ Time Frame: 2 months ]
    Male vs Female

  2. Factors associated with sustained improvement: Age [ Time Frame: 2 months ]
    Years

  3. Factors associated with sustained improvement; Somatisation score [ Time Frame: 2 months ]
    Standardized score

  4. Factors associated with sustained improvement: Quality of life [ Time Frame: 2 months ]
    Standardized score

  5. Factors associated with sustained improvement: Anal resting pressure [ Time Frame: 2 months ]
    mmHg

  6. Factors associated with sustained improvement: Colonic transit time [ Time Frame: 2 months ]
    Hours

  7. Factors associated with sustained improvement: Monthly bowel frequency [ Time Frame: 2 months ]
    N°/day/month

  8. Factors associated with sustained improvement: Monthly Stool form [ Time Frame: 2 months ]
    Bristol stool form score (1-7): score/day/month

  9. Factors associated with sustained improvement: Defecatory symptoms [ Time Frame: 2 months ]
    Monthly N° of symptoms associated with defecation: N°/day/month

  10. Factors associated with sustained improvement: Abdominal pain severity [ Time Frame: 2 months ]
    pain score (0-10) /day/month


Other Outcome Measures:
  1. Agreement between M-PAC-Sym and Satisfaction Score [ Time Frame: 1 month ]
    The agreement between M-PAC-SYM defined non-responders (change of M-PAC-SYM<0.24) and unsatisfied patients (satisfaction score ≤4) requiring treatment switch.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
outpatients reffering to a third level center
Criteria

Inclusion Criteria:

  • All patients aged 18 - 80 years old with IBS-C and CC. The diagnosis of CC and IBS-C will be defined according to Rome III criteria.

Exclusion Criteria:

  • Patients with secondary causes of CC
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813616


Locations
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Italy
IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano, Italy, 20148
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Investigators
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Principal Investigator: Guido Basilisco Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Guido Basilisco, Doctor, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT02813616    
Other Study ID Numbers: SC-2016
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Constipation
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases