Probiotic Treatment of Ulcerative Colitis With Trichuris Suis Ova (TSO) (PROCTO)
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|ClinicalTrials.gov Identifier: NCT03565939|
Recruitment Status : Recruiting
First Posted : June 21, 2018
Last Update Posted : September 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis Chronic Moderate||Biological: Trichuris suis ova Biological: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double-blind randomised, placebo-controlled, 24 weeks, comparative, exploratory phase II proof of concept trial.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Probiotic Treatment of Ulcerative Colitis With Trichuris Suis Ova (TSO)|
|Actual Study Start Date :||May 4, 2018|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Active Comparator: Trichuris suis ova (TSO)
7500 TSO suspension, orally every second week for 24 weeks.
Biological: Trichuris suis ova
Eggs from the pig whipworm
Other Name: TSO
Placebo Comparator: Placebo
Solution without TSO orally every second week for 24 weeks
Solution without TSO
- Response (Full MAYO) [ Time Frame: 24 weeks ]The proportion of TSO patients, compared with placebo patients (ie. a proportional difference), who obtain a reduction of 3 or more full MAYO (not an abbreviation) score steps between the baseline visit and the end of trial visit (week 24). The full MAYO score (range 0-12) is the sum of 4 clinical scores (stool frequency, rectal bleeding, findings on endoscopy, physician's global assessment) each scored with a value 0 (normal), 1, 2, or 3 (worst).
- Remission (Full MAYO) [ Time Frame: 24 weeks ]Proportions of TSO patients, compared with placebo patients (ie. a proportional difference), who obtain a full MAYO (not an abbreviation) score less than or equal to 2 at the end of trial visit (week 24) (remission)
- Reduction in use of steroid [ Time Frame: 24 weeks ]Mean value of total accumulated sum of milligram oral and rectal glucocorticosteroids taken by TSO patients during the trial compared with the corresponding mean value among placebo patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03565939
|Contact: Michelle V Prosberg, MDemail@example.com|
|Contact: Andreas M Petersen, MD, Ph.Dfirstname.lastname@example.org|
|Principal Investigator:||Andreas M Petersen, MD, Ph.D||Hvidovre University Hospital|