Quality of Life in Patients With Short Bowel Syndrome Treated Without and With Teduglutide - a Prospective Nested Matched Pair Analysis

NCT04733066 | Unknown DMC

• 1 other identifier: IIR-DE-002726
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Short Bowel Syndrome; Intestinal Failure

Keywords

Quality of Life; Teduglutide; GLP-2 Analogue

Outcome Measures

Primary Outcomes (3)

• changes in QoL data during teduglutide therapy

  SBS-QoL, SF-36

  through study completion, an average of 1 year

• changes in QoL data of patients without teduglutide therapy

  SBS-QoL, SF-36

  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

  through study completion, an average of 1 year

Secondary Outcomes (7)

• BMI in kg/m^2

  through study completion, an average of 1 year

• Body cell mass in kg

  through study completion, an average of 1 year

• citrulline levels

  through study completion, an average of 1 year

• stool characteristics by bristol stool scale

  through study completion, an average of 1 year

• parenteral support frequency

  through study completion, an average of 1 year

Study Arms (2)

Non-treatment Group

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)

Teduglutide-treated Group

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

Interventions

Teduglutide DRUG

Intervention group consists of patients, who receive teduglutide within routine medical care

Teduglutide-treated Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• SBS-associated adult chronic IF with parenteral nutritional support
• signed informed consent

You may not qualify if:

• teduglutide stop before study initiation
• refusal or withdrawal of consent

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Takeda: collaborator

Study Sites (1)

Charite University, Berlin, Germany

Berlin, 10117, Germany

RECRUITING

Related Publications (4)

• Jeppesen PB, Pertkiewicz M, Forbes A, Pironi L, Gabe SM, Joly F, Messing B, Loth S, Youssef NN, Heinze H, Berghofer P. Quality of life in patients with short bowel syndrome treated with the new glucagon-like peptide-2 analogue teduglutide--analyses from a randomised, placebo-controlled study. Clin Nutr. 2013 Oct;32(5):713-21. doi: 10.1016/j.clnu.2013.03.016. Epub 2013 Mar 28.

  PMID: 23587733 BACKGROUND

• Chen K, Mu F, Xie J, Kelkar SS, Olivier C, Signorovitch J, Jeppesen PB. Impact of Teduglutide on Quality of Life Among Patients With Short Bowel Syndrome and Intestinal Failure. JPEN J Parenter Enteral Nutr. 2020 Jan;44(1):119-128. doi: 10.1002/jpen.1588. Epub 2019 Apr 21.

  PMID: 31006876 BACKGROUND

• Bluthner E, Bednarsch J, Pape UF, Karber M, Maasberg S, Gerlach UA, Pascher A, Wiedenmann B, Pratschke J, Stockmann M. Advanced liver function assessment in patients with intestinal failure on long-term parenteral nutrition. Clin Nutr. 2020 Feb;39(2):540-547. doi: 10.1016/j.clnu.2019.02.039. Epub 2019 Mar 5.

  PMID: 30885502 BACKGROUND

• Bluthner E, Bednarsch J, Stockmann M, Karber M, Pevny S, Maasberg S, Gerlach UA, Pascher A, Wiedenmann B, Pratschke J, Pape UF. Determinants of Quality of Life in Patients With Intestinal Failure Receiving Long-Term Parenteral Nutrition Using the SF-36 Questionnaire: A German Single-Center Prospective Observational Study. JPEN J Parenter Enteral Nutr. 2020 Feb;44(2):291-300. doi: 10.1002/jpen.1531. Epub 2019 Mar 13.

  PMID: 30864177 BACKGROUND

MeSH Terms

Conditions

Short Bowel Syndrome; Intestinal Failure

Interventions

teduglutide

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Elisabeth Blüthner, MD

CONTACT

004930450665209; elisabeth.bluethner@charite.de

Sophie Pevny, Dr.

CONTACT

sophie.pevny@charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 29, 2020
• First Posted: February 1, 2021
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2022
• Last Updated: February 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)