An observational study in Short Bowel Syndrome and Intestinal Failure, sponsored by Charite University, Berlin, Germany. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-01.
Sponsored by Charite University, Berlin, Germany · Observational
The aim of this prospective longitudinal study is to compare the quality of life of short bowel patients prior to and on teduglutide treatment with a non-treated patient group in a matched-pair design.
Short bowel syndrome (SBS) is a malabsorptive disorder mostly caused by surgical interventions, which may result in chronic intestinal failure (cIF). The incidence is progressively increasing due to more aggressive surgical and medical approaches. Parenteral nutrition is still the mainstay of treatment for patients with irreversible cIF. New hormonal therapies hold promise by romoting mucosal growth and intestinal absorption and thereby leading to a consequent reduction in parenteral support and symptoms related to large stomal or faecal losses. Outside the typical primary endpoints of cost data, quality of life (QoL) is an important and yet underappreciated consideration of the effectiveness of targeted therapies. In the clinical STEPS trial, Jeppesen et al. have previously shown a significant improvement of the SBS-QoL total score after 24 week treatment with teduglutide longitudinally but could not identify a statistical significance to the placebo group. Accordingly, Chen and colleagues carried out a post hoc analysis of the afore mentioned clinical trial data based on 86 patients and could confirm the results auf Jeppesen et al. Taken together, these clinical trial data did not show a direct benefit of teduglutide treatment on QoL in these patients, while real life data on QoL changes are not available yet. During the release of teduglutide in Germany, the PNLiver trial (DRKS00010993) recruited chronic intestinal failure patients with parenteral nutrition from 2014 till 2019 to evaluate the capability of non-invasive liver function tests in cIF patients in a cross-sectional (n=90) and longitudinal study (n=20. All participants underwent study visits including clinical examination, dynamic liver function assessment, comprehensive blood tests, nutritional status assessment and quality of life assessment (Short Form 36 [SF-36] and SBS-QoL). Therefore, we have a comprehensive data set of a large monocentric cIF cohort prior to teduglutide treatment. Consequently, our unique QoL data from the PNLiver trail enables a followup assessment for an observation period above 24 weeks of patients who were in the meantime exposed to teduglutide in a real life setting. Nevertheless, QoL also tends to improve with longer duration on HPN. Therefore, we are aiming to extend the results with a pairwise matched control group from non teduglutide-treated PNLiver trail patients and collect follow-up data from this group accordingly.
159 studies on the registry are indexed under Short Bowel Syndrome; 24 are open to participants now.
This study's planned enrollment of 40 is below the median of 53 across 36 observational studies indexed under Short Bowel Syndrome.
Browse Short Bowel Syndrome studies →Charite University, Berlin, Germany is the lead sponsor of 857 studies on the registry; 129 are open to participants now.
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A comprehensive data set of a large monocentric cIF cohort prior to teduglutide treatment from the PNLiver trail already exists. Consequently, we aim to have a follow-up assessment of patients who are in the meantime treated with teduglutide as a clinical routine procedure.
We aim to extent the results with a pairwise matched control group from non teduglutide-treated PNLiver trail patients and collect follow-up data from this group accordingly.
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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.
1. Quality of life assessment (SBS-QoL, SF- 36) 2. Nutrition status assessment (BIA, BMI) 3. Assessment of functional absorptive small bowel length (citrulline) 4. Clinical data (nutritional program, stool characteristics)
1. Quality of life assessment (SBS-QoL, SF- 36) 2. Nutrition status assessment (BIA, BMI) 3. Assessment of functional absorptive small bowel length (citrulline) 4. Clinical data (nutritional program, stool characteristics)
Drug: Teduglutide
Intervention group consists of patients, who receive teduglutide within routine medical care
changes in QoL data during teduglutide therapy
SBS-QoL, SF-36
Time frame: through study completion, an average of 1 year
changes in QoL data of patients without teduglutide therapy
SBS-QoL, SF-36
Time frame: through study completion, an average of 1 year
changes in QoL data of teduglutide treated patients compared to changes in pairwise matched controls
SBS-QoL, SF-36
Time frame: through study completion, an average of 1 year
BMI in kg/m^2
weight and height will be combined to report BMI in kg/m\^2
Time frame: through study completion, an average of 1 year
Body cell mass in kg
measured by bioelectrical impedance analysis
Time frame: through study completion, an average of 1 year
citrulline levels
Time frame: through study completion, an average of 1 year
stool characteristics by bristol stool scale
seven types of stool from 1 (hard lumps) till 7 (watery)
Time frame: through study completion, an average of 1 year
parenteral support frequency
Time frame: through study completion, an average of 1 year
parenteral support volume
Time frame: through study completion, an average of 1 year
parenteral support calories
Time frame: through study completion, an average of 1 year
Plan to share: No
This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Charite University, Berlin, Germany →