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

NCT03565939 | Completed Phase 2

• 2 other identifiers: PROCTO2017-004772-65
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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

Keywords

Ulcerative Colitis; Trichuris suis; Trichuris suis ova; Probiotic; IBD; Inflammatory bowel diseases; Anti inflammatory; Hygiene Hypothesis; Helminths; Microbiome; MAYO

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Response (Full Mayo)

  24 weeks

• Steroid free remission (Full Mayo)

  24 weeks

• Endoscopic remission

  24 weeks

• Symptomatic remission

  12 and 24 weeks

• Time to remission

  0-24 weeks

Study Arms (2)

Trichuris suis ova (TSO)

ACTIVE COMPARATOR

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

Biological: Trichuris suis ova

Placebo

PLACEBO COMPARATOR

Solution without TSO orally every second week for 24 weeks

Biological: Placebo

Interventions

Trichuris suis ova BIOLOGICAL

Eggs from the pig whipworm

Also known as: TSO

Trichuris suis ova (TSO)

Placebo BIOLOGICAL

Solution without TSO

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Between 18 and 75 years of age
• 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
• Mayo-score between 6 and 10 and including 6 and 10 corresponding to moderately active disease
• Calprotectin ≥ 250 µg/g and an endoscopic Mayo score ≥ 2
• Negative pregnancy test in females of childbearing potential and the use of an acceptable effective method of contraception
• 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
• Tapered down from last oral steroid ≥ 4 weeks ago

You may not qualify if:

• Disease extension corresponding only to E1 (proctitis), i.e. less than 15 cm from the anal verge
• Bowel surgery, except appendectomy and removal of polyps
• Septic complications
• Evidence of infectious diarrhea (i.e. pathogenic bacteria or Clostridium difficile toxin in stool)
• Abscess, perforation, active fistula or perianal lesions
• Abnormal hepatic function (ALAT or ALP \> 2.5 x ULN at screening), liver cirrhosis, or portal hypertension
• Abnormal renal function (Creatinine \> ULN) at screening
• 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
• Any condition associated with significant immunosuppression
• 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
• 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)).
• Treatment with systemic glucocorticosteroid within the last 4 weeks or treatment with topical steroid within the last 2 weeks prior to baseline
• 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
• Immunization with live vaccines within 12 weeks prior to baseline or during the trial
• 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.

Sponsors & Collaborators

• ParaTech A/S: lead

Study Sites (1)

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Andreas M Petersen, MD, Ph.D

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 21, 2018
• Study Start: May 4, 2018
• Primary Completion: January 10, 2022
• Study Completion: January 10, 2022
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)