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

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

Sponsors

Lead Sponsor: ParaTech A/S

Source 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.

Overall Status Active, not recruiting
Start Date 2018-05-04
Completion Date 2022-01-01
Primary Completion Date 2021-12-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Response (Full MAYO) 24 weeks
Secondary Outcome
Measure Time Frame
Remission (Full MAYO) 24 weeks
Reduction in use of steroid 24 weeks
Enrollment 119
Condition
Intervention

Intervention Type: Biological

Intervention Name: Trichuris suis ova

Description: Eggs from the pig whipworm

Arm Group Label: Trichuris suis ova (TSO)

Other Name: TSO

Intervention Type: Biological

Intervention Name: Placebo

Description: Solution without TSO

Arm Group Label: Placebo

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

75 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Andreas M Petersen, MD, Ph.D Principal Investigator Hvidovre University Hospital
Overall Contact

Last Name: Michelle V Prosberg, MD

Phone: +4530343353

Email: [email protected]

Location
Facility: Hvidovre Hospital
Location Countries

Denmark

Verification Date

2021-11-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Trichuris suis ova (TSO)

Type: Active Comparator

Description: 7500 TSO suspension, orally every second week for 24 weeks.

Label: Placebo

Type: Placebo Comparator

Description: Solution without TSO orally every second week for 24 weeks

Acronym PROCTO
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Double-blind randomised, placebo-controlled, 24 weeks, comparative, exploratory phase II proof of concept trial.

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description: Double-blind

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