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Ulcerative Colitis Chronic ModeratePhase 2PROCTONCT03565939

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

A Phase 2 study testing Trichuris suis ova in people with Ulcerative Colitis Chronic Moderate, run by ParaTech A/S at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ulcerative Colitis Chronic Moderate
What is being tested?
Trichuris suis ova
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
119 participants
Where
1 siteDenmark
Study dates
4 May 2018to 10 Jan 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent
  • Between 18 and 75 years of age
  • Established diagnosis of UC confirmed by endoscopic (sigmoidoscopy) and histological criteria, at least 3 months prior to inclusion
  • 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
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  • 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

Who cannot join

  • 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
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  • 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.
  • Well-founded doubt about the patient's cooperation, (e.g., addiction to alcohol or drugs).
  • Existing or intended pregnancy or breast-feeding
  • Participation in another clinical trial within the last 60 days, simultaneous participation in another clinical trial

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Hvidovre Hospital

    Hvidovre, 2650

Other trials in Denmark

About this study

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.

Being tested
Trichuris suis ova, Placebo
Keywords
Ulcerative Colitis, Trichuris suis, Trichuris suis ova, Probiotic, IBD, Inflammatory bowel diseases, Anti inflammatory, Hygiene Hypothesis, Helminths, Microbiome, MAYO
Medical subject headings
Colitis, Ulcerative, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trichuris suis ovaBiological

    Also called TSO

    Eggs from the pig whipworm

  • PlaceboBiological

    Solution without TSO

Study groups in NCT03565939
Study groupRoleWhat they receive
Trichuris suis ova (TSO)Active comparator7500 TSO suspension, orally every second week for 24 weeks.
Receives: Biological: Trichuris suis ova
PlaceboPlacebo comparatorSolution without TSO orally every second week for 24 weeks
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 24 weeks

Secondary outcomes (7)

  1. Response (Full Mayo)

    To achieve reduction of full Mayo score of 4 or more steps at 24 weeks (ITT, PP, complete steroid-free)

    Measured: 24 weeks

  2. 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)

    Measured: 24 weeks

  3. 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)

    Measured: 24 weeks

  4. 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)

    Measured: 12 and 24 weeks

  5. 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)

    Measured: 0-24 weeks

  6. 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)

    Measured: 0-24 weeks

  7. Disease severity

    To decrease disease severity assessed by pMayo scores at 12 to 24 weeks

    Measured: 12-24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2018
  2. Study start4 May 2018
  3. Primary completion10 Jan 2022
  4. Study completion10 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double-blind randomised, placebo-controlled, 24 weeks, comparative, exploratory phase II proof of concept trial.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
119 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03565939
Sponsor's protocol ID
PROCTO
Other IDs
2017-004772-65, 2017
Acronym
PROCTO
Status last verified
Apr 2022
First submitted
22 May 2018
Last updated
22 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trichuris suis ova in people with Ulcerative Colitis Chronic Moderate, run by ParaTech A/S at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Remission (Full Mayo) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03565939.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.

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