Ongoing Clinical Trials for Intestinal Ischaemia
Currently, there is 1 ongoing clinical trial investigating new treatment approaches for intestinal ischaemia. This trial is exploring the use of oral antibiotics to improve outcomes in patients with acute mesenteric ischemia, a serious condition caused by sudden loss of blood flow to the intestines. The study is being conducted in France and aims to determine whether antibiotics can reduce the risk of intestinal tissue death and mortality.
Clinical trial locations
Study on the Effectiveness of Oral Antibiotics Gentamicin and Metronidazole in Patients with Acute Mesenteric Ischemia
This clinical trial is investigating whether oral antibiotics can help patients with acute mesenteric ischemia, a serious condition where blood flow to the intestines is suddenly blocked, causing tissue damage. The study is testing two specific antibiotics: gentamicin (given as an 80 mg injection solution) and metronidazole (given as a 500 mg tablet). Both medications are administered orally, or through a feeding tube if the patient cannot swallow.
Who can participate:
- Adults between 18 and 90 years of age
- Patients diagnosed with acute mesenteric ischemia caused by a blocked blood vessel (arterial occlusive origin)
- The condition must have started less than 7 days ago, with visible signs of intestinal injury confirmed through symptoms, blood tests, or imaging
- A significant blockage (more than 75%) must be present in the superior mesenteric artery, which is the main blood vessel supplying the intestines
- The patient must be admitted to one of the participating hospitals in the SURVI care network, including Beaujon Hospital or Bichat Hospital in France
- Both men and women can participate
Who cannot participate:
- Patients without a confirmed diagnosis of acute mesenteric ischemia
- Patients younger than 18 or older than 65 years (note: there appears to be some overlap with inclusion criteria, which allows up to 90 years)
- Vulnerable individuals who cannot provide informed consent
What the trial involves:
Participants are randomly assigned to receive either the antibiotic combination or a placebo. This randomization ensures unbiased results. The treatment period lasts up to 14 days, during which patients are closely monitored.
Throughout the study, researchers measure blood levels of the antibiotics on the day of randomization and again on days 7 and 14. This helps them understand how the body processes these drugs. The main goal is to determine whether the antibiotics can reduce the occurrence of intestinal tissue death (necrosis) or mortality within 30 days of starting treatment.
The study also tracks several other important outcomes, including overall survival rates, the development of short bowel syndrome (a condition where the intestines cannot absorb enough nutrients), the extent of any intestinal tissue that needs to be surgically removed, and any organ failure that may occur. Safety is carefully monitored, including checking for side effects, allergic reactions to the antibiotics, the development of antibiotic-resistant bacteria, and healthcare-associated infections.
The investigational treatment:
The trial is testing oral antibiotics as a potential treatment to reduce the risk of intestinal tissue death and mortality in patients with this condition. Antibiotics work by targeting and stopping the growth of bacteria, which may help prevent infections that can complicate acute mesenteric ischemia. While antibiotics are commonly used to treat various infections, their specific role in managing acute mesenteric ischemia is still being investigated through this research.
The study began recruiting patients in 2024 and is expected to continue until 2027, providing valuable information about whether this antibiotic treatment can improve outcomes for patients with this serious condition.
Summary
Currently, there is only one active clinical trial for intestinal ischaemia, specifically focusing on acute mesenteric ischemia. This trial is being conducted exclusively in France, within the SURVI care network at specialized hospitals including Beaujon and Bichat. The research is exploring an innovative approach using oral antibiotics (gentamicin and metronidazole) to prevent intestinal tissue death and reduce mortality in patients with this life-threatening condition. The trial represents an important step in understanding whether antibiotics can play a role in managing this serious vascular emergency, beyond their traditional use in treating infections. Results from this study, expected by 2027, may provide valuable insights into new treatment options for patients experiencing sudden loss of blood flow to the intestines.
