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D-galactose: a simple sugar studied in clinical research

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In short

D-galactose is a naturally occurring simple sugar that the body uses as an energy source and building block. In the clinical trial registry, d-galactose appears as part of a research product being studied for chronic wounds colonized by Pseudomonas aeruginosa, a type of bacteria. The trial is a Phase 2 study with 90 planned participants and is currently authorised to begin.

D-galactose is a naturally occurring simple sugar, also known as a monosaccharide. It is one of the sugars the human body uses as a source of energy and as a building block for larger molecules. In the EU Clinical Trials Information System, d-galactose appears in connection with a research product being tested for chronic wounds colonized by Pseudomonas aeruginosa, a type of bacteria that can infect wounds.

Key points

  • D-galactose is a naturally occurring simple sugar found in the body and in foods.
  • One Phase 2 clinical trial is listed in the EU registry, with 90 planned participants.
  • The trial studies a product containing d-galactose for chronic wounds colonized by Pseudomonas aeruginosa.
  • The trial status is Authorised, meaning it has received approval to start.
  • Researchers measure safety and the reduction of bacterial load after 14 days of treatment.

What is d-galactose?

D-galactose is a simple sugar, a monosaccharide, that occurs naturally in the body. It is a source of energy and a component of larger carbohydrates. A 2025 study in rats looked at the effects of chronic oral d-galactose intake and found that it induced oxidative stress, a state in which harmful molecules called free radicals build up in the body, but did not cause overt organ dysfunction. In the clinical trial registry, d-galactose is part of a product being investigated for wound care, not a medicine authorised for any condition.

How does d-galactose work?

The exact way d-galactose might work in the clinical trial setting is not described in the registry data. The trial record focuses on the product PB-TX-01, which contains d-galactose among its components, and on its comparison with an antiseptic solution. The study measures whether the product reduces the amount of Pseudomonas aeruginosa bacteria in chronic wounds after 14 days of topical application. The animal study suggests that d-galactose can influence oxidative stress in the body when given orally, but this is a different setting from the wound trial.

Which conditions is it used or studied for?

  • Chronic wounds colonized by Pseudomonas aeruginosa — long-lasting wounds that do not heal normally and are infected with a specific type of bacteria. The trial investigates whether a product containing d-galactose can reduce the bacterial load in these wounds.

How is d-galactose given?

In the clinical trial, the product containing d-galactose is given as a topical application on the wound. The trial records a 2 gram amount applied directly to the wound surface. The comparator, Serasept® 2 Antiseptische Lösung, is a 10 millilitre antiseptic solution also applied topically. The animal study used oral administration of d-galactose, which is a different route.

What do the clinical trials show?

There is one clinical trial listed in the EU registry for the product containing d-galactose. It is a Phase 2 interventional study with a planned enrollment of 90 participants. The trial status is Authorised, meaning it has received approval to start but no results are available yet.

What are the trials measuring?

The trial measures two main outcomes. The first is the incidence, severity, and causality of treatment-emergent adverse events and serious adverse events within 90 days. The second is the reduction of Pseudomonas aeruginosa bacterial load after 14 days of treatment, measured by the presence of colony forming units in bacterial swabs and categorized into levels from "not existent" to "abundant". A reduction is defined as at least one level less on this scale.

Who can take part?

The trial is designed for patients with chronic wounds colonized by Pseudomonas aeruginosa. The registry record does not provide further details on inclusion or exclusion criteria beyond this condition.

What side effects are known?

The registry record does not list known side effects for the product containing d-galactose, as the trial is designed to collect safety information. The trial measures treatment-emergent adverse events and serious adverse events within 90 days as its primary safety outcome. The animal study reported that chronic oral d-galactose induced oxidative stress but did not cause overt organ dysfunction in rats.

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