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Probiotic Treatment of Ulcerative Colitis With Trichuris Suis Ova (TSO) (PROCTO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03565939
Recruitment Status : Recruiting
First Posted : June 21, 2018
Last Update Posted : September 22, 2020
Information provided by (Responsible Party):
ParaTech A/S

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Chronic Moderate Biological: Trichuris suis ova Biological: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
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
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
Biological: Placebo
Solution without TSO

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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)

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03565939

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Contact: Michelle V Prosberg, MD +4530343353
Contact: Andreas M Petersen, MD, Ph.D

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Hvidovre Hospital Recruiting
Hvidovre, Denmark, 2650
Contact: Michelle V Prosberg, MD    +4530343353   
Contact: Andreas M Petersen, MD, Ph.D   
Sponsors and Collaborators
ParaTech A/S
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Principal Investigator: Andreas M Petersen, MD, Ph.D Hvidovre University Hospital
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Responsible Party: ParaTech A/S Identifier: NCT03565939    
Other Study ID Numbers: PROCTO
2017-004772-65 ( EudraCT Number )
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ParaTech A/S:
Ulcerative Colitis
Trichuris suis
Trichuris suis ova
Inflammatory bowel diseases
Anti inflammatory
Hygiene Hypothesis
Additional relevant MeSH terms:
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Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases