Parasite protein injection aims to tame Crohn's Flare-Ups
NCT ID NCT02281916
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tested the safety of P28GST, a protein from a parasite, in 10 adults with moderate Crohn's disease. Participants received three injections over three months. The goal was to see if the protein could safely control inflammation, especially after intestinal surgery. The study is complete, but results are not yet widely available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- P28GST (a protein from a parasite, given as an injection)
- What this could lead to
- If it works, this could point toward a new way to control inflammation in Crohn's disease without long-term side effects.
- What could go wrong
- This is a very small, early-phase safety study with only 10 people. It is not designed to prove effectiveness, and the approach is experimental.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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10 people
The number who actually took part.
- Start date
-
Mar 2014
- Finished
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Feb 2018
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Subjects between the ages of ≥18 years at inclusion. * Subjects with ileal or ileo-colic CD without fistula * Subjects operated or not * CDAI score \< 220 * no concomitant treatment excepted salicylates * Women of child bearing potential must be negative for pregnancy prior to study enrolment * contraceptive means : females of childbearing potential as well as males are required to use adequate contraceptive methods for 6 months starting at the inclusion, i;e 4 months after the 3rd injection . * No tobacco consumption (end date of tobacco consumption 8 days before surgery). * Signed consent form * French social security coverage. Exclusion Criteria: * Subject who use of azathioprine, anti-TNF (Tumor Necrosis Factor), methotrexate, Vedolizumab, Ustekinumab and other immunosuppressors for 8 weeks before first injection of P28GST * Subject who use of corticosteroids for 15 days before first injection of P28GST * Subject with history of vaccine hyper sensitivity or allergy. * Subject with any other clinical manifestation determined by the investigator * Subject wih AIDS, B or C hepatitis.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHRU, Hôpital Claude Huriez
Lille, 59037, France
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Centre Hospitalier Dunkerque
Dunkirk, France
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Centre Hospitalier de Boulogne
Boulogne-sur-Mer, France
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Centre Hospitalier,
Valenciennes, France
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Centre hospitalier
Amiens, France
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