Short Bowel SyndromeNCT00248573
Mechanisms of Adaptation in Human Short Bowel Syndrome
An observational study of Short Bowel Syndrome, run by Emory University at 2 sites in United States.
Trial summary
This is an observational, natural history trial of mechanisms of gut adaptation in adult short bowel syndrome (SBS). Patients with SBS (< 200 cm small bowel ± colon) will be studied initially 2-9 months after the last small bowel resection and again exactly 6 months after the initial study. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Short Bowel Syndrome
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2004to Jul 2013
- 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: 1) Adults aged 18-75 with less than 200cm small bowel remaining after latest(SBR); 2) Subject able to enter the study within 2-24 months of latest SBR; 3)(BMI) ≥ 17 kg/m2; 4) Subject is living at home, clinically stable and expected to survive at least one year; 5) Subject able to take some oral solid diet and oral medications; 6) Intact stomach and duodenum and at least 30 cm of in-continuity jejunum and/or ileum (presence of residual colon is not a specific eligibility criterion); 7) Accurate records available on residual small bowel/colonic length (accurate tape measurement in operation room or small bowel follow-through performed within 3 months of entry); 8) Subject has the ability to understand the requirements of the study, provide written informed consent and agrees to participate in all assessments.
Inclusion Criteria: 1) Adult male or female with less than 200 small bowel remaining after latest small bowel resection (SBR); 2) Subject able to enter the study within 2-24 months of latest SBR; 3) Age 18-75 years; 4) Body mass index (BMI) ≥ 17 kg/m2; 5) Subject is living at home, clinically stable and expected to survive at least one year; 6) Subject able to take some oral solid diet and oral medications; 7) Intact stomach and duodenum and at least 30 cm of in-continuity jejunum and/or ileum (presence of residual colon is not a specific eligibility criterion); 8) Accurate records available on residual small bowel/colonic length (accurate tape measurement in operation room or small bowel follow-through performed within 3 months of entry); 9) Subject has the ability to understand the requirements of the study, provide written informed consent and agrees to participate in all GCRC assessments.
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Exclusion Criteria: 1) Evidence of active malignancy during the past 5 years (with the exception of non-metastatic skin cancer; 2) Evidence of uncontrolled hypertension, congestive heart failure, myocardial infarction or angina; 3) History or evidence of stroke or clinically serious neurologic dysfunction since last SBR; 4) Evidence of acute infectious illness requiring hospitalization within the previous 4 weeks; 5) History of steroid-or oxygen-dependent lung disease; 6) History of mental deficiency, alcoholism, or other substance abuse problems; 7) Pregnancy or lactation ; 8) Evidence of worsening of Crohn's disease within 2 months prior to study (i.e. worsening diarrhea, new abdominal pain, rectal bleeding, and, when clinically applicable, abnormal radiographic and/or endoscopic findings); 9) Condition requiring daily systemic corticosteroids exceeding a dose equivalent to 10 mg/d of prednisone or significant immunosuppressant therapy (with the exception of Crohn´s disease); 11) Subject has received glutamine or growth hormone within 2 months prior to study.
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Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
This is an observational, natural history trial of mechanisms of gut adaptation in adult short bowel syndrome (SBS). Patients with SBS (< 200 cm small bowel ± colon) will be studied initially 2-9 months after the last small bowel resection and again exactly 6 months after the initial study. GCRC-studies will examine intestinal nutrient absorption, gut barrier functions and gut mucosal biopsy specimens for markers of nutrient transport and cell proliferation and apoptosis.
Read the detailed description
Short bowel syndrome (SBS) is a condition that occurs after massive surgical removal of sections of the small bowel required to treat conditions such as Crohn's disease, lack of adequate blood flow to the intestine, trauma, twisting of the bowel and other disorders. Patients with SBS develop severe diarrhea, weight loss, loss of nutrients in the stool, malnutrition, dehydration and deficiency of specific nutrients. SBS is thus a major cause of intestinal failure in adults and children. SBS has a high rate of death and medical complications and patients experience enormous health care-related costs and decreased quality of life. Patients with SBS often require intravenous feeding [known as parenteral nutrition (PN)] due to chronic malabsorption and malnutrition and also commonly develop infections from intestinal bacteria, suggesting abnormalities in the intestinal "barrier" to bacteria present in the intestine. In animal models of SBS, increased growth of the intestinal lining (mucosa) and improved nutrient absorption occur over time (intestinal adaptation). Although SBS patients commonly exhibit decreased diet-induced diarrhea within the first 2 years after intestinal surgery, very little is known about how the intestinal mucosa adapts in patients with SBS. The proposed pilot study will be the first comprehensive study of serial changes in gut mucosal structure and function in the early period (2-30 months) of SBS in humans. Our Specific Aims are designed to determine: 1) whether the residual small bowel and colonic mucosa in SBS patients exhibits adaptive growth, with concomitantly improved nutrient absorption and gut barrier function; 2) The underlying mechanisms of early gut adaptation in human SBS, by evaluating changes in mucosal cell growth and production of key molecules that are responsible for nutrient transport/absorption and gut barrier function; and 3) The utility of plasma citrulline concentrations and serum flagellin antibody titers as markers for human intestinal absorptive capacity and gut barrier function, respectively. Our research will provide important and new information on the natural history and underlying causes of early intestinal adaptation in man. This information will be valuable in the design of future therapeutic studies in patients with SBS that hold promise for improving the rehabilitation of these individuals.
- Conditions
- Short Bowel Syndrome
- Medical subject headings
- Short Bowel Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
intestinal gene expression
Measured: 2011-2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2005 (estimated)
- Study startOct 2004
- Primary completionSep 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas R. Ziegler, MD, Emory University
- Investigators
- Thomas R Ziegler, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00248573
- Sponsor's protocol ID
- 0299-2004
- Other IDs
- R03DK067123
- Status last verified
- Dec 2013
- First submitted
- 3 Nov 2005
- Last updated
- 17 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Adaptation in Human Short Bowel Syndrome
- ClinicalTrials.gov ID
- NCT00248573
- Acronym / sponsor ID
- 0299-2004
- Conditions
- Short Bowel Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Oct 2004
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 4 Nov 2005 (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.
This is an observational, natural history trial of mechanisms of gut adaptation in adult short bowel syndrome (SBS). Patients with SBS (< 200 cm small bowel ± colon) will be studied initially 2-9 months after the last small bowel resection and again exactly 6 months after the initial study. GCRC-studies will examine intestinal nutrient absorption, gut barrier functions and gut mucosal biopsy specimens for markers of nutrient transport and cell proliferation and apoptosis.
Detailed description
Short bowel syndrome (SBS) is a condition that occurs after massive surgical removal of sections of the small bowel required to treat conditions such as Crohn's disease, lack of adequate blood flow to the intestine, trauma, twisting of the bowel and other disorders. Patients with SBS develop severe diarrhea, weight loss, loss of nutrients in the stool, malnutrition, dehydration and deficiency of specific nutrients. SBS is thus a major cause of intestinal failure in adults and children. SBS has a high rate of death and medical complications and patients experience enormous health care-related costs and decreased quality of life. Patients with SBS often require intravenous feeding [known as parenteral nutrition (PN)] due to chronic malabsorption and malnutrition and also commonly develop infections from intestinal bacteria, suggesting abnormalities in the intestinal "barrier" to bacteria present in the intestine. In animal models of SBS, increased growth of the intestinal lining (mucosa) and improved nutrient absorption occur over time (intestinal adaptation). Although SBS patients commonly exhibit decreased diet-induced diarrhea within the first 2 years after intestinal surgery, very little is known about how the intestinal mucosa adapts in patients with SBS. The proposed pilot study will be the first comprehensive study of serial changes in gut mucosal structure and function in the early period (2-30 months) of SBS in humans. Our Specific Aims are designed to determine: 1) whether the residual small bowel and colonic mucosa in SBS patients exhibits adaptive growth, with concomitantly improved nutrient absorption and gut barrier function; 2) The underlying mechanisms of early gut adaptation in human SBS, by evaluating changes in mucosal cell growth and production of key molecules that are responsible for nutrient transport/absorption and gut barrier function; and 3) The utility of plasma citrulline concentrations and serum flagellin antibody titers as markers for human intestinal absorptive capacity and gut barrier function, respectively. Our research will provide important and new information on the natural history and underlying causes of early intestinal adaptation in man. This information will be valuable in the design of future therapeutic studies in patients with SBS that hold promise for improving the rehabilitation of these individuals.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1) Adults aged 18-75 with less than 200cm small bowel remaining after latest(SBR); 2) Subject able to enter the study within 2-24 months of latest SBR; 3)(BMI) ≥ 17 kg/m2; 4) Subject is living at home, clinically stable and expected to survive at least one year; 5) Subject able to take some oral solid diet and oral medications; 6) Intact stomach and duodenum and at least 30 cm of in-continuity jejunum and/or ileum (presence of residual colon is not a specific eligibility criterion); 7) Accurate records available on residual small bowel/colonic length (accurate tape measurement in operation room or small bowel follow-through performed within 3 months of entry); 8) Subject has the ability to understand the requirements of the study, provide written informed consent and agrees to participate in all assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
intestinal gene expression
Time frame: 2011-2012
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 17 Dec 2013.
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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.
Thomas R Ziegler, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Short Bowel Syndrome, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 17 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
intestinal gene expression (time frame: 2011-2012). 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 17 Dec 2013.