IBS, Diarrhea PredominantNCT00619125
Proposal Evaluating Time-specific Relationships Between Variables of Pain, Stress, and Bloating in IBS Diarrhea and Constipation Symptoms Using a Palm Pilot
An observational study of IBS, Diarrhea Predominant and IBS, Constipation Predominant, run by University of North Carolina, Chapel Hill.
Trial summary
Purpose: The associations between pain, stress, bloating, and their short interval temporal relationships to defecation in IBS D, C \& M are of great interest to the field of functional GI disorders, but have not been adequately studied. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- IBS, Diarrhea Predominant, IBS, Constipation Predominant, IBS, Mixed Symptoms
- What is being tested?
- palm pilot recording responses to questionnaires
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Apr 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 80 male and female subjects will be recruited: 20 with IBS D; 20 with IBS C; 20 with IBS M; 20 control (no bowel symptoms). We will target patients who have maintained a diagnosis of IBS with Diarrhea (IBS-D), IBS with Constipation (IBS-C, IBS with Mixed Stool pattern (IBS-M), using Rome III Criteria as well as control subjects without bowel symptoms. Subject participation will be limited to patients who maintain mild or moderate symptom severity score on the functional bowel disorders severity index (FBDSI.) providing they have at least 3 symptom episodes of pain or discomfort in a given week, to assure adequate data collection.
Who may be able to join
- The subject signs and dates a written informed consent form (ICF) prior to any study-related activities, including discontinuation of any prohibited medications.
- The subject has been diagnosed with either IBS-C, IBS-D, IBS-M, or has no history of gastrointestinal symptoms (control group).
- The subject has at least 3 pain episodes a week and does not have constant, unremitting abdominal pain.
- The subject is at least 18 years of age and less than 75 years of age at the time of the screening visit.
- The subject is fluent in English.
- The subject is an ambulatory outpatient. Ambulatory is defined as not depending exclusively on a wheelchair for mobility. Nursing home subjects may be enrolled provided they are ambulatory. Subjects with spinal cord injuries resulting in paraplegia may not be enrolled.
Who cannot join
- The subject exhibits evidence of a biochemical or structural abnormality of the digestive tract. These conditions include (but are not limited to) the following:
- Inflammatory bowel disease (Crohn's disease or ulcerative colitis),
- GI surgery (with the exceptions of appendectomy; cholecystectomy; benign polypectomy; fundoplication without gas bloat syndrome, 6 months post-surgery; herniorrhaphy without bowel resection, 1 month post-surgery; hemorrhoidectomy, at least 2 months post-surgery; and hiatal hernia repair),
- GI malignancy, GI obstruction
- In the opinion of the investigator the subject has a concurrent illness or disability (excluding IBS) that may affect the interpretation of clinical efficacy and/or safety data or otherwise contraindicates participation in this clinical study (e.g., an unstable cardiovascular, renal, hepatic, pulmonary, endocrine, metabolic, GI, hematological, or neurological condition).
- The subject has been diagnosed with a major psychiatric disorder within the past 2 years that required hospitalization and/or involved an attempted suicide (e.g., major depression or psychoses). Subjects diagnosed with a major psychiatric disorder that did not require hospitalization or involve an attempted suicide must have remained on a stable dose of medication for at least 6 months prior to the screening visit.
- The subject has a history of alcohol or substance abuse within the past 2 years.
- The subject has any evidence or treatment of malignancy (other than localized basal cell, squamous cell skin cancer or cancer in situ that has been resected) within the previous 5 years.
About this study
Official title: A Proposal to Evaluate Time-specific Relationships Between Variables of Pain, Stress, and Bloating in the Onset of IBS Diarrhea and Constipation Symptoms Using Ecological Momentary Assessment (EMA)
Purpose: The associations between pain, stress, bloating, and their short interval temporal relationships to defecation in IBS D, C \& M are of great interest to the field of functional GI disorders, but have not been adequately studied. Broad recall based assessments (i.e.,over past week or month) of pain and bloating have been key features of the diagnosis of IBS, however such long term retrospective recall of symptom experience has been shown to be unreliable and influenced by outside factors (heuristics, recall bias, etc.). Short interval assessment may provide a more accurate picture of patient symptom experience Participants: Patients with IBS in general and IBS subtypes (IBS-C, D, M) Procedures (methods): Study participants could be asked to record data at randomly assigned points throughout the day, as well as during the course of a diarrheal or constipated stool (i.e., prior to and right after a bowel movement).
- Being tested
- palm pilot recording responses to questionnaires
- Medical subject headings
- Ichthyosis Bullosa of Siemens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
palm pilot recording responses to questionnairesOther
Short interval assessment (provided by data from palm pilot) may provide a more accurate picture of patient symptom experience.
| Study group | Role | What they receive |
|---|---|---|
| A | 20 patients with IBS C Receives: Other: palm pilot recording responses to questionnaires | |
| D | 20 Subjects without IBS | |
| B | 20 patients with IBS D Receives: Other: palm pilot recording responses to questionnaires | |
| C | 20 patients with IBS M Receives: Other: palm pilot recording responses to questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine relation of pain and bloating relative to average pain and bloating scores
Measured: 2 weeks
Secondary outcomes (1)
determine the association of acute stress with increased pain and bloating scores or with defecation in IBS
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startApr 2008
- Primary completionMar 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS, Diarrhea PredominantStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc.
- Responsible party
- Sponsor
- Investigators
- Douglas Drossman, MD, Principal investigator, UNC-Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619125
- Sponsor's protocol ID
- 07-1782
- Status last verified
- Oct 2011
- First submitted
- 24 Jan 2008
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proposal to Evaluate Time-specific Relationships Between Variables of Pain, Stress, and Bloating in the Onset of IBS Diarrhea and Constipation Symptoms Using Ecological Momentary Assessment (EMA)
- ClinicalTrials.gov ID
- NCT00619125
- Acronym / sponsor ID
- 07-1782
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc.
- Study start
- Apr 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 20 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: The associations between pain, stress, bloating, and their short interval temporal relationships to defecation in IBS D, C \& M are of great interest to the field of functional GI disorders, but have not been adequately studied. Broad recall based assessments (i.e.,over past week or month) of pain and bloating have been key features of the diagnosis of IBS, however such long term retrospective recall of symptom experience has been shown to be unreliable and influenced by outside factors (heuristics, recall bias, etc.). Short interval assessment may provide a more accurate picture of patient symptom experience Participants: Patients with IBS in general and IBS subtypes (IBS-C, D, M) Procedures (methods): Study participants could be asked to record data at randomly assigned points throughout the day, as well as during the course of a diarrheal or constipated stool (i.e., prior to and right after a bowel movement).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | – | Other: palm pilot recording responses to questionnaires20 patients with IBS C |
| D | – | –20 Subjects without IBS |
| B | – | Other: palm pilot recording responses to questionnaires20 patients with IBS D |
| C | – | Other: palm pilot recording responses to questionnaires20 patients with IBS M |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 80 male and female subjects will be recruited: 20 with IBS D; 20 with IBS C; 20 with IBS M; 20 control (no bowel symptoms). We will target patients who have maintained a diagnosis of IBS with Diarrhea (IBS-D), IBS with Constipation (IBS-C, IBS with Mixed Stool pattern (IBS-M), using Rome III Criteria as well as control subjects without bowel symptoms. Subject participation will be limited to patients who maintain mild or moderate symptom severity score on the functional bowel disorders severity index (FBDSI.) providing they have at least 3 symptom episodes of pain or discomfort in a given week, to assure adequate data collection.
Key inclusion criteria (6 listed)
- The subject signs and dates a written informed consent form (ICF) prior to any study-related activities, including discontinuation of any prohibited medications.
- The subject has been diagnosed with either IBS-C, IBS-D, IBS-M, or has no history of gastrointestinal symptoms (control group).
- The subject has at least 3 pain episodes a week and does not have constant, unremitting abdominal pain.
- The subject is at least 18 years of age and less than 75 years of age at the time of the screening visit.
- The subject is fluent in English.
Key exclusion criteria (8 listed)
- The subject exhibits evidence of a biochemical or structural abnormality of the digestive tract. These conditions include (but are not limited to) the following:
- In the opinion of the investigator the subject has a concurrent illness or disability (excluding IBS) that may affect the interpretation of clinical efficacy and/or safety data or otherwise contraindicates participation in this clinical study (e.g., an unstable cardiovascular, renal, hepatic, pulmonary, endocrine, metabolic, GI, hematological, or neurological condition).
- The subject has been diagnosed with a major psychiatric disorder within the past 2 years that required hospitalization and/or involved an attempted suicide (e.g., major depression or psychoses). Subjects diagnosed with a major psychiatric disorder that did not require hospitalization or involve an attempted suicide must have remained on a stable dose of medication for at least 6 months prior to the screening visit.
- The subject has a history of alcohol or substance abuse within the past 2 years.
- The subject has any evidence or treatment of malignancy (other than localized basal cell, squamous cell skin cancer or cancer in situ that has been resected) within the previous 5 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| palm pilot recording responses to questionnairesShort interval assessment (provided by data from palm pilot) may provide a more accurate picture of patient symptom experience. | Other | A, B, C |
Primary outcome
To determine relation of pain and bloating relative to average pain and bloating scores
Time frame: 2 weeks
1 secondary outcome
determine the association of acute stress with increased pain and bloating scores or with defecation in IBS
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Drossman, MD principal investigator
UNC-Chapel Hill
Questions about this trial
What is this clinical trial studying?
An observational study of IBS, Diarrhea Predominant and IBS, Constipation Predominant, run by University of North Carolina, Chapel Hill.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine relation of pain and bloating relative to average pain and bloating scores (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2017.