TRUD™

The latest treatment available for mild to moderate Ulcerative Colitis (UC) patients.

Description of TRUD™

TRUD™ was registered for sale in Europe in April 2013. TRUD™ comes in a box of 7 enema bottles, 1 bottle is to be used daily, for 28 days.

Clinical trial and results

A clinical study was conducted in Istituto Clinico Humanitas, (Milan) Italy on patients suffering from mild to moderate UC in the acute phase (active flare-ups). This was conducted to show the safety and effectiveness of TRUD™ in UC.

Results
Statistically significant results described below were seen in patients who used TRUD™ at the end of the study (week 4). TRUD™ was shown to be effective in reducing the clinical symptoms and improving endoscopic scores of patients that suffer from UC.

Graphical representation of the clinical results can be seen below.

Response rate: This is the level of response to TRUD™ seen in patients.

Remission rate: This is the number of patients that experienced remission in terms of both their symptoms and more quantitatively, in their endoscopy results.

Healing
Almost a quarter of the patients in the study showed complete mucosal healing in the colon demonstrating that TRUD™ is effective in facilitating the healing of the affected colon of patients with mild to moderate UC in the acute phase.

Side effects
No serious adverse events were seen in any patient during the course of the trial. Some mild transient side effects (e.g. flatulence, nausea, headache, etc.) were seen which could be due to the procedure of using an enema.

Ease of use
TRUD™ was found to be well tolerated as a form of treatment for patients with mild to moderate UC. A patient can administer it without help from others.

How does TRUD™ work?

TRUD™ contains 2 different specific types of Sodium Hyaluronate (also known as Hyaluronic Acid, or Hyaluronan) as well as a natural muco-adhesive agent (a substance that will ensure the adherence of Sodium Hyaluronate to the mucosa for a longer period). Sodium Hyaluronate has two very important properties which could explain why TRUD™ has shown effectiveness in treating patients with mild to moderate UC. These properties are specific to the size of the Sodium Hyaluronate. The 2 properties are:

1. Facilitate healing
2. Protection

Low molecular weight Sodium Hyaluronate
The low molecular weight (small sized) Sodium Hyaluronate that can be found in TRUD™ is able to help improve the healing rate of the affected region (in the colon). This is done through a process called epithelial restitution. That is, these small sized Sodium Hyaluronate molecules promote the rate of healing at the muscosal level which is affected by UC.

High molecular weight Sodium Hyaluronate
The high molecular weight (large sized) Sodium Hyaluronate is able to adhere specifically to where the colon is affected and protect this inflamed and ulcerated area whilst the healing is taking place. This is important as the colon contains a lot of bacteria and toxins which could be accidentally absorbed in the ulcerated area or, could cause further inflammation.

A graphical representation of how the 2 different Sodium Hyaluronates in TRUD™ work (click on the image to zoom)

---

Where to find TRUD™

TRUD™ can be bought at your local pharmacy because it is a CE marked Class IIa medical device according to regulatory classification. You do not require a prescription from a physician to buy TRUD™ but it is highly recommended that you discuss with your doctor if you are thinking of using it for the first time.
You can contact us if you are unable to find it at your local pharmacy.

Patient information leaflet

Click here for the leaflet that can be found in every box of TRUD™