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

NCT ID: NCT03565939

Last Updated: 2022-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-04
• Study Completion Date: 2022-01-10

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.

Conditions

Ulcerative Colitis Chronic Moderate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Trichuris suis ova (TSO)

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

Group Type: ACTIVE_COMPARATOR

Trichuris suis ova

Intervention Type: BIOLOGICAL

Eggs from the pig whipworm

Placebo

Solution without TSO orally every second week for 24 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Solution without TSO

Interventions

Trichuris suis ova

Eggs from the pig whipworm

Intervention Type: BIOLOGICAL

Placebo

Solution without TSO

Intervention Type: BIOLOGICAL

Other Intervention Names

TSO

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ParaTech A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas M Petersen, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Locations

Hvidovre Hospital

Hvidovre, , Denmark

Countries

Denmark

Other Identifiers

2017-004772-65

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PROCTO

Identifier Type: -

Identifier Source: org_study_id