Clinical Trial Results:
Influence of UDCA on fecal bile salt composition of IBD patients:
pilot study
Summary
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EudraCT number |
2014-003141-10 |
Trial protocol |
BE |
Global end of trial date |
10 Jan 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
04 Dec 2021
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First version publication date |
04 Dec 2021
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Other versions |
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Summary report(s) |
Summary |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
AGO/2014/004
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Ghent University Hospital
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Sponsor organisation address |
Corneel Heymanslaan 10, Ghent, Belgium, 9000
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Public contact |
Hiruz CTU, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
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Scientific contact |
Hiruz CTU, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
07 Sep 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
07 Sep 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
10 Jan 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To research the effects of UDCA administration on the fecal metabolites (especially bile salts) and fecal microbiota of IBD patients and healthy volunteers.
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Protection of trial subjects |
Ethics review and approval, informed consent, supportive care and routine monitoring.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Nov 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Belgium: 54
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Worldwide total number of subjects |
54
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EEA total number of subjects |
54
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
52
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From 65 to 84 years |
2
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85 years and over |
0
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Recruitment
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Recruitment details |
54 patients were screened from 05-06-2015 till 07-09-2016. 54 patients were enrolled. Patients that completed the study could not be determined as 32 CRFs were not completed/available. End of trial notification was dated 07-09-2016 (last patient last visit) and submitted to EC and CA 10-01-2019. | ||||||||||||||||||||
Pre-assignment
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Screening details |
Control group: age between 18-65 yrs, abscence of important gastrointestinal co-morbidity IBD group: Crohn's disease or Colitis ulcerosa, active disease at inclusion (CDAI ≥ 150 or UCDAI ≥ 3) IBD remission group: Crohn's disease or Colitis ulcerosa, Clinical remission (CDAI < 150 or UCDAI ≤ 2) PSC group: known PSC, Chronic treatment with UDCA | ||||||||||||||||||||
Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||
Blinding implementation details |
N/A
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Treatment arm | ||||||||||||||||||||
Arm description |
Two groups of patients were included. All patients received ursodeoxycholic acid: active IBD group (20 individuals), IBD remission group (1 individual) | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
Ursodeoxycholic acid
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Investigational medicinal product code |
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Other name |
UrsoFalk
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Per day, 250 mg milligram(s)
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Arm title
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No treatment arm | ||||||||||||||||||||
Arm description |
No treatment arm contains the healthy volunteer group (25 individuals) and primary sclerosing cholangitis group (0 individuals). | ||||||||||||||||||||
Arm type |
No intervention | ||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Unknown | ||||||||||||||||||||
Arm description |
ICF IBD signed but no CRF completed and thus impossible to determine in which group the subjects were enrolled. | ||||||||||||||||||||
Arm type |
unkown | ||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
Treatment arm
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Reporting group description |
Two groups of patients were included. All patients received ursodeoxycholic acid: active IBD group (20 individuals), IBD remission group (1 individual) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
No treatment arm
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Reporting group description |
No treatment arm contains the healthy volunteer group (25 individuals) and primary sclerosing cholangitis group (0 individuals). | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Unknown
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Reporting group description |
ICF IBD signed but no CRF completed and thus impossible to determine in which group the subjects were enrolled. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Treatment arm
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Reporting group description |
Two groups of patients were included. All patients received ursodeoxycholic acid: active IBD group (20 individuals), IBD remission group (1 individual) | ||
Reporting group title |
No treatment arm
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Reporting group description |
No treatment arm contains the healthy volunteer group (25 individuals) and primary sclerosing cholangitis group (0 individuals). | ||
Reporting group title |
Unknown
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Reporting group description |
ICF IBD signed but no CRF completed and thus impossible to determine in which group the subjects were enrolled. |
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End point title |
Change in fecal metabolite composition (especially bile salts) [1] | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Until 4 weeks after start of study.
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis available |
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Notes [2] - Impossible to determine as 32 CRFs were not completed/available. [3] - Impossible to determine as 32 CRFs were not completed/available. [4] - Impossible to determine as 32 CRFs were not completed/available. |
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No statistical analyses for this end point |
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End point title |
Change in fecal microbiota composition [5] | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Until 4 weeks after start of study.
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Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis available |
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Notes [6] - Impossible to determine as 32 CRFs were not completed/available. [7] - Impossible to determine as 32 CRFs were not completed/available. [8] - Impossible to determine as 32 CRFs were not completed/available. |
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No statistical analyses for this end point |
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End point title |
Tolerability of UDCA administration (adverse effects) | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Until 4 weeks after start of study.
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Notes [9] - Impossible to determine as 32 CRFs were not completed/available. [10] - Impossible to determine as 32 CRFs were not completed/available. [11] - Impossible to determine as 32 CRFs were not completed/available. |
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No statistical analyses for this end point |
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End point title |
Change in CDAI/UCDAI score, calprotectin levels | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Until 4 weeks after start of study.
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Notes [12] - Impossible to determine as 32 CRFs were not completed/available. [13] - Impossible to determine as 32 CRFs were not completed/available. [14] - Impossible to determine as 32 CRFs were not completed/available. |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Overall Study
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Assessment type |
Non-systematic | ||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||
Dictionary version |
24
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Reporting groups
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Reporting group title |
Treatment arm
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Reporting group description |
Two groups of patients were included. All patients received ursodeoxycholic acid: active IBD group (20 individuals), IBD remission group (1 individual) | ||||||||||||||||||||
Reporting group title |
No treatment arm
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Reporting group description |
No treatment arm contains the healthy volunteer group (26 individuals) and primary sclerosing cholangitis group (0 individuals). | ||||||||||||||||||||
Reporting group title |
Unknown
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Reporting group description |
ICF IBD signed but no CRF completed and thus impossible to determine in which group the subjects were enrolled. | ||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||
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Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No non-serious adverse events were recorded for the participating patients |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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16 Dec 2014 |
Amendment to information of the CT application form, the protocol and the ICF form have been made due to a change in the quality of IMP and conduct or management of the trial.
- Commercial investigational product was changed from Ursochol (150 mg tablets) to UrsoFalk (250 mg tablets). Active component remained the same.
- An extra group of patients was added: a PSC group (=Patients with known primary sclerosing cholangitis). |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
32 CRFs were not completed/available. No articles were published as no sufficient data was available. |