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Trial record 1 of 42 for:    TSO
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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 12, 2019
Sponsor:
Information provided by (Responsible Party):
ParaTech A/S

Tracking Information
First Submitted Date  ICMJE May 22, 2018
First Posted Date  ICMJE June 21, 2018
Last Update Posted Date September 12, 2019
Actual Study Start Date  ICMJE May 4, 2018
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2018)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2018)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Probiotic Treatment of Ulcerative Colitis With Trichuris Suis Ova (TSO)
Official Title  ICMJE Probiotic Treatment of Ulcerative Colitis With Trichuris Suis Ova (TSO)
Brief Summary The PROCTO trial is a double-blind randomized, placebo-controlled, 24-week, comparative, exploratory phase II proof of concept trial. The trial will be conducted with 2 treatment groups as a parallel group comparison and will serve to compare a 7500 TSO regimen vs. placebo for achieving clinically meaningful responses in Ulcerative Colitis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
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)
Masking Description:
Double-blind
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis Chronic Moderate
Intervention  ICMJE
  • Biological: Trichuris suis ova
    Eggs from the pig whipworm
    Other Name: TSO
  • Biological: Placebo
    Solution without TSO
Study Arms  ICMJE
  • Active Comparator: Trichuris suis ova (TSO)
    7500 TSO suspension, orally every second week for 24 weeks.
    Intervention: Biological: Trichuris suis ova
  • Placebo Comparator: Placebo
    Solution without TSO orally every second week for 24 weeks
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2018)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Signed informed consent
  2. Between 18 and 75 years of age
  3. Established diagnosis of UC confirmed by endoscopic (sigmoidoscopy) and histological criteria, at least 3 months prior to inclusion
  4. Disease extension corresponding to E2 (left side colitis) or E3 (extensive colitis) according to the Montreal Classification, i.e. at least 15 cm from anal verge, confirmed by an index sigmoidoscopy
  5. Mayo-score between 6 and 10 and including 6 and 10 corresponding to moderately active disease
  6. Calprotectin ≥ 250 µg/g and an endoscopic Mayo score ≥ 2
  7. Negative pregnancy test in females of childbearing potential and the use of an acceptable effective method of contraception
  8. No treatment or if treated with 5-Aminosalicyl acid (5-ASA): 5-ASA ≥ 8 weeks with a stable dose for at least 4 weeks both oral and rectal use
  9. Tapered down from last oral steroid ≥ 4 weeks ago

Exclusion Criteria:

  1. Disease extension corresponding only to E1 (proctitis), i.e. less than 15 cm from the anal verge
  2. Bowel surgery, except appendectomy and removal of polyps
  3. Septic complications
  4. Evidence of infectious diarrhea (i.e. pathogenic bacteria or Clostridium difficile toxin in stool)
  5. Abscess, perforation, active fistula or perianal lesions
  6. Abnormal hepatic function (ALAT or ALP > 2.5 x ULN at screening), liver cirrhosis, or portal hypertension
  7. Abnormal renal function (Creatinine > ULN) at screening
  8. Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder, which in the opinion of the investigator might have an influence on the patient's compliance or the interpretation of the results
  9. Any condition associated with significant immunosuppression
  10. Treatment with immunosuppressants or anti-cancer drugs, e.g., anti-TNF-α agents, anti-integrin agents, azathioprine or 6-MP, 6-thioguanine, methotrexate, tacrolimus, cyclophosphamide, or cyclosporine within the last 3 months prior to baseline
  11. Treatment with systemic broad-spectrum antibiotics (e.g. metronidazole or ciprofloxacin), anti-parasitic medications, or probiotic (e.g. fecal transplantation) medication within the last 4 weeks prior to baseline, except for probiotic lactobacillus or bifidobacteria within 2 week prior to baseline (and minimum 1 week before screening visit (sampling and biopsies)).
  12. Treatment with systemic glucocorticosteroid within the last 4 weeks or treatment with topical steroid within the last 2 weeks prior to baseline
  13. Application of systemic non-steroidal anti-inflammatory drugs (NSAIDs) within 2 weeks before baseline visit for more than 3 consecutive days, except acetylsalicylic acid ≤ 350 mg/d which is allowed
  14. Immunization with live vaccines within 12 weeks prior to baseline or during the trial
  15. Travelling to rural districts in countries outside of Europe, USA, Australia or Canada within the last 12 weeks prior to baseline or during trial participation. If patients travel outside of Europe, USA, Australia or Canada they must be tested negative in the standard stool tests (parasites, bacteria and virus) when they return, as at the screening visit.
  16. Well-founded doubt about the patient's cooperation, (e.g., addiction to alcohol or drugs).
  17. Existing or intended pregnancy or breast-feeding
  18. Participation in another clinical trial within the last 60 days, simultaneous participation in another clinical trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michelle V Prosberg, MD +4530343353 michelle.vernstroem.prosberg@regionh.dk
Contact: Andreas M Petersen, MD, Ph.D andreas.munk.petersen@regionh.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03565939
Other Study ID Numbers  ICMJE PROCTO
2017-004772-65 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ParaTech A/S
Study Sponsor  ICMJE ParaTech A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andreas M Petersen, MD, Ph.D Hvidovre University Hospital
PRS Account ParaTech A/S
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP