Protocol for a randomised, double-blinded, placebo-controlled, double-dummy 6-week clinical trial comparing the treatment effects of the glucagon-like peptide 1 receptor agonist liraglutide versus the bile acid sequestrant colesevelam on bile acid malabsorption

Publikation: Bidrag til tidsskriftKommentar/debatfagfællebedømt

Standard

Protocol for a randomised, double-blinded, placebo-controlled, double-dummy 6-week clinical trial comparing the treatment effects of the glucagon-like peptide 1 receptor agonist liraglutide versus the bile acid sequestrant colesevelam on bile acid malabsorption. / Kårhus, Martin Lund; Brønden, Andreas; Lyng Forman, Julie; Haaber, Anne; Vilsbøll, Tina; Sonne, David Peick; Knop, Filip K.Krag.

I: BMJ Open, Bind 11, Nr. 2, e044711, 2021.

Publikation: Bidrag til tidsskriftKommentar/debatfagfællebedømt

Harvard

Kårhus, ML, Brønden, A, Lyng Forman, J, Haaber, A, Vilsbøll, T, Sonne, DP & Knop, FKK 2021, 'Protocol for a randomised, double-blinded, placebo-controlled, double-dummy 6-week clinical trial comparing the treatment effects of the glucagon-like peptide 1 receptor agonist liraglutide versus the bile acid sequestrant colesevelam on bile acid malabsorption', BMJ Open, bind 11, nr. 2, e044711. https://doi.org/10.1136/bmjopen-2020-044711

APA

Kårhus, M. L., Brønden, A., Lyng Forman, J., Haaber, A., Vilsbøll, T., Sonne, D. P., & Knop, F. K. K. (2021). Protocol for a randomised, double-blinded, placebo-controlled, double-dummy 6-week clinical trial comparing the treatment effects of the glucagon-like peptide 1 receptor agonist liraglutide versus the bile acid sequestrant colesevelam on bile acid malabsorption. BMJ Open, 11(2), [e044711]. https://doi.org/10.1136/bmjopen-2020-044711

Vancouver

Kårhus ML, Brønden A, Lyng Forman J, Haaber A, Vilsbøll T, Sonne DP o.a. Protocol for a randomised, double-blinded, placebo-controlled, double-dummy 6-week clinical trial comparing the treatment effects of the glucagon-like peptide 1 receptor agonist liraglutide versus the bile acid sequestrant colesevelam on bile acid malabsorption. BMJ Open. 2021;11(2). e044711. https://doi.org/10.1136/bmjopen-2020-044711

Author

Kårhus, Martin Lund ; Brønden, Andreas ; Lyng Forman, Julie ; Haaber, Anne ; Vilsbøll, Tina ; Sonne, David Peick ; Knop, Filip K.Krag. / Protocol for a randomised, double-blinded, placebo-controlled, double-dummy 6-week clinical trial comparing the treatment effects of the glucagon-like peptide 1 receptor agonist liraglutide versus the bile acid sequestrant colesevelam on bile acid malabsorption. I: BMJ Open. 2021 ; Bind 11, Nr. 2.

Bibtex

@article{fe7c4c0d0eec42eb90d3a3d762efc8c2,
title = "Protocol for a randomised, double-blinded, placebo-controlled, double-dummy 6-week clinical trial comparing the treatment effects of the glucagon-like peptide 1 receptor agonist liraglutide versus the bile acid sequestrant colesevelam on bile acid malabsorption",
abstract = "Introduction Bile acid malabsorption (BAM) is a socially debilitating disease characterised by high stool frequency and urgency caused by a spillover of bile acids into the colon. Bile acid sequestrants (BASs) have limited therapeutic effect but represent the only available treatment option. Cases reporting total remission of BAM-related symptoms after treatment with liraglutide, a glucagon-like peptide 1 analogue, prompted us to design a clinical trial investigating the therapeutic effect of this compound in patients with BAM. Methods and analysis Fifty adult individuals with moderate or severe BAM as assessed by the 75 selenium-homotaurocholic acid test (SeHCAT) will, after a run-in period of 10 days with no BAM treatment, be randomised to either treatment with the BAS colesevelam or liraglutide (double blinded) for 6 weeks. Daily symptom diaries and questionnaires will be filled in. Blood and faecal samples will be collected and SeHCAT will be performed at baseline, after week 3 and at end of trial. The primary endpoint is change in daily stool frequency. Secondary endpoints include changes from baseline in questionnaires, biochemistry, SeHCAT and faecal bile acid content and microbial composition. Ethics and dissemination The study complies with Danish and European Union legislation and is approved by the Danish Medicines Agency, the Regional Scientific Ethics Committee of the Capital Region of Denmark and the Danish Data Protection Agency. The study is monitored by the Capital Region of Denmark's good clinical practice unit. All results, positive, negative and inconclusive, will be disseminated at national and/or international scientific meetings and in peer-reviewed scientific journals. Trial registration number EudraCA: 2018-003575-34; Pre-results. ",
keywords = "clinical trials, gastroenterology, hepatobiliary disease, malabsorption",
author = "K{\aa}rhus, {Martin Lund} and Andreas Br{\o}nden and {Lyng Forman}, Julie and Anne Haaber and Tina Vilsb{\o}ll and Sonne, {David Peick} and Knop, {Filip K.Krag}",
year = "2021",
doi = "10.1136/bmjopen-2020-044711",
language = "English",
volume = "11",
journal = "BMJ Open",
issn = "2044-6055",
publisher = "BMJ Publishing Group",
number = "2",

}

RIS

TY - JOUR

T1 - Protocol for a randomised, double-blinded, placebo-controlled, double-dummy 6-week clinical trial comparing the treatment effects of the glucagon-like peptide 1 receptor agonist liraglutide versus the bile acid sequestrant colesevelam on bile acid malabsorption

AU - Kårhus, Martin Lund

AU - Brønden, Andreas

AU - Lyng Forman, Julie

AU - Haaber, Anne

AU - Vilsbøll, Tina

AU - Sonne, David Peick

AU - Knop, Filip K.Krag

PY - 2021

Y1 - 2021

N2 - Introduction Bile acid malabsorption (BAM) is a socially debilitating disease characterised by high stool frequency and urgency caused by a spillover of bile acids into the colon. Bile acid sequestrants (BASs) have limited therapeutic effect but represent the only available treatment option. Cases reporting total remission of BAM-related symptoms after treatment with liraglutide, a glucagon-like peptide 1 analogue, prompted us to design a clinical trial investigating the therapeutic effect of this compound in patients with BAM. Methods and analysis Fifty adult individuals with moderate or severe BAM as assessed by the 75 selenium-homotaurocholic acid test (SeHCAT) will, after a run-in period of 10 days with no BAM treatment, be randomised to either treatment with the BAS colesevelam or liraglutide (double blinded) for 6 weeks. Daily symptom diaries and questionnaires will be filled in. Blood and faecal samples will be collected and SeHCAT will be performed at baseline, after week 3 and at end of trial. The primary endpoint is change in daily stool frequency. Secondary endpoints include changes from baseline in questionnaires, biochemistry, SeHCAT and faecal bile acid content and microbial composition. Ethics and dissemination The study complies with Danish and European Union legislation and is approved by the Danish Medicines Agency, the Regional Scientific Ethics Committee of the Capital Region of Denmark and the Danish Data Protection Agency. The study is monitored by the Capital Region of Denmark's good clinical practice unit. All results, positive, negative and inconclusive, will be disseminated at national and/or international scientific meetings and in peer-reviewed scientific journals. Trial registration number EudraCA: 2018-003575-34; Pre-results.

AB - Introduction Bile acid malabsorption (BAM) is a socially debilitating disease characterised by high stool frequency and urgency caused by a spillover of bile acids into the colon. Bile acid sequestrants (BASs) have limited therapeutic effect but represent the only available treatment option. Cases reporting total remission of BAM-related symptoms after treatment with liraglutide, a glucagon-like peptide 1 analogue, prompted us to design a clinical trial investigating the therapeutic effect of this compound in patients with BAM. Methods and analysis Fifty adult individuals with moderate or severe BAM as assessed by the 75 selenium-homotaurocholic acid test (SeHCAT) will, after a run-in period of 10 days with no BAM treatment, be randomised to either treatment with the BAS colesevelam or liraglutide (double blinded) for 6 weeks. Daily symptom diaries and questionnaires will be filled in. Blood and faecal samples will be collected and SeHCAT will be performed at baseline, after week 3 and at end of trial. The primary endpoint is change in daily stool frequency. Secondary endpoints include changes from baseline in questionnaires, biochemistry, SeHCAT and faecal bile acid content and microbial composition. Ethics and dissemination The study complies with Danish and European Union legislation and is approved by the Danish Medicines Agency, the Regional Scientific Ethics Committee of the Capital Region of Denmark and the Danish Data Protection Agency. The study is monitored by the Capital Region of Denmark's good clinical practice unit. All results, positive, negative and inconclusive, will be disseminated at national and/or international scientific meetings and in peer-reviewed scientific journals. Trial registration number EudraCA: 2018-003575-34; Pre-results.

KW - clinical trials

KW - gastroenterology

KW - hepatobiliary disease

KW - malabsorption

U2 - 10.1136/bmjopen-2020-044711

DO - 10.1136/bmjopen-2020-044711

M3 - Comment/debate

C2 - 33558360

AN - SCOPUS:85100707193

VL - 11

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 2

M1 - e044711

ER -

ID: 257972024