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

Ulcerative Colitis Chronic Moderate Clinical Trial

— PROCTO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03565939
• Other study ID #: PROCTO
• Secondary ID: 2017-004772-65
• Status: Completed
• Phase: Phase 2
• Start date: May 4, 2018
• Est. completion date: January 10, 2022

Study information

• Verified date: April 2022
• Source: ParaTech A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: January 10, 2022
• Est. primary completion date: January 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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-a 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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis Chronic Moderate

Intervention

Biological:
• Trichuris suis ova
Eggs from the pig whipworm
• Placebo
Solution without TSO

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
ParaTech A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission (Full Mayo)	To achieve clinical remission defined as full Mayo score = 2 at 24 weeks (long-term efficacy) (ITT, PP). The full Mayo score (range 0-12) is the sum of 4 clinical scores (stool frequency, rectal bleeding, mucosal appearance at endoscopy, physician rating of disease activity) each scored with a value 0 (normal), 1, 2, or 3 (worst).	24 weeks
Secondary	Response (Full Mayo)	To achieve reduction of full Mayo score of 4 or more steps at 24 weeks (ITT, PP, complete steroid-free)	24 weeks
Secondary	Steroid free remission (Full Mayo)	To achieve complete steroid free clinical remission defined as full Mayo score = 2 at 24 weeks (long-term efficacy) (complete steroid-free)	24 weeks
Secondary	Endoscopic remission	To achieve endoscopic remission defined as mucosal appearance Mayo sub-score of 0 or 1 at 24 weeks (long-term efficacy) (ITT, PP, complete steroid-free)	24 weeks
Secondary	Symptomatic remission	To achieve symptomatic remission defined as stool frequency Mayo sub-score of 0 or 1 and rectal bleeding Mayo sub-score of 0 at 12 weeks (short-term efficacy) and at 24 weeks (long-term efficacy) (ITT, PP, complete steroid-free)	12 and 24 weeks
Secondary	Time to remission	To reduce time to achieve remission defined as time to achieve a pMayo score = 1 and time to achieve symptomatic remission defined as stool frequency Mayo sub-score of 0 or 1 and rectal bleeding Mayo sub-score of 0 (0-24 weeks) (ITT, PP, complete steroid-free)	0-24 weeks
Secondary	Time to response	To reduce time to achieve response defined as time to achieve reduction in pMayo score of 3 or more steps (0-24 weeks) (ITT, PP, complete steroid-free)	0-24 weeks
Secondary	Disease severity	To decrease disease severity assessed by pMayo scores at 12 to 24 weeks	12-24 weeks