Galacto-oligosaccharide for Acute GVHD
This study is evaluating whether a carbohydrate supplement may help prevent graft-versus-host disease after stem cell transplant.
See full descriptionAbout the trial for Acute GVHD
Treatment Groups
This trial involves 2 different treatments. Galacto-oligosaccharide is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.
Eligibility
This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Galacto-oligosaccharide will improve 2 primary outcomes and 7 secondary outcomes in patients with Acute GVHD. Measurement will happen over the course of 30 days.
Patient Q & A Section
What is acute gvhd?
Immune disorders are a well-recognized class of diseases in pediatric oncology. They present a significant challenge to pediatric oncologists and pediatricians due to the scarcity of published pediatric data on immune disorders in pediatric oncology. A review of the most commonly published cases on a single subject was done for the purpose of providing an overview on relevant clinical information.\n\nIn 2006, a 10-year-old girl presented with acute gvHD associated with allogeneic haematopoietic stem cell transplant (HSCT). Her symptoms included fever, increased liver enzymes, and skin eruptions, but a bone marrow analysis revealed no signs of overt transplant rejection.
How many people get acute gvhd a year in the United States?
The cumulative average rate of acute GVHD development is 4.5 cases per 10,000 stem cell transplant recipients per year. The incidence of acute GVHD development in patients with a high-risk (i.e., >10% relapse risk) disease pattern is significantly higher than that reported in studies of allo SCT patients.
What causes acute gvhd?
Current gfh can act as a risk factor for developing autoimmune disease later in life, as well as the occurrence of the autoimmune disorder nephritis. Data from a recent study suggest that current gfh may have a causal role in disease.
What are the signs of acute gvhd?
Symptoms of acute gvHD include fever, skin redness, headache, vomiting or gastrointestinal bleeding. There is a high frequency of gvHD in patients with herpesviruses, the most common cause of acute febrile viral encephalitis.
What are common treatments for acute gvhd?
The treatment of acute graft-vs.-host disease (aGVHD) mostly consists of topical treatments, such as corticosteroids or vitamin A analogues such as isotretinoin. If these agents are ineffective, more systemic treatments exist (such as cytoreductive chemotherapy and bone marrow transplantation). Treatment of severe aGVHD depends on the severity of disease and the comorbidities, such as graft reaction, infections, and GVHD.
Can acute gvhd be cured?
Acute gvHD has two main types and is characterized by different levels of Tregs and Th1 cells. Therefore, Tregs and Th1 cells are thought to be the targets of both oral or IVIg therapy.
Does galacto-oligosaccharide improve quality of life for those with acute gvhd?
Administration of GOS may be an effective method for treating patients with acute gvHD. Findings from a recent study suggest that GOS may help improve HRQoL in patients with gvHD.
How does galacto-oligosaccharide work?
We conclude that GOS is effective in reducing the number of episodes of acute-onset gastritis and in reducing the number of bowel movements and abdominal pain after a GI challenge with water-soluble oligosaccharides in children without clinical or biologic signs of intestinal bacterial overgrowth.
Has galacto-oligosaccharide proven to be more effective than a placebo?
Data from a recent study is the first randomized trial to show the superiority of GOS when given in a daily dose of 40 mg/kg orally to non-pregnant, non-delivery-sick infants with acute gastroenteritis compared with placebo. Its administration may decrease duration of acute gastroenteritis and its risk of complications. The safety of GOS was also validated in this study. Clinicaltrials.gov registration number: NCT01393545.
Does acute gvhd run in families?
A common phenotype of GHD in children with and without siblings who develop childhood GHD exists. These data emphasize a common genetic background for pediatric GHD. GHD is unlikely to be caused by chance inheritance from a single, sporadic gene.
What is the average age someone gets acute gvhd?
The average age that children experience a first episode of acute gvHD is 2.8 years, which is later than the age of children diagnosed with chronic gvHD, whose average is 5.6 years.
What is the latest research for acute gvhd?
In summary, current literature supports, and provides evidence for, an association between the pathogen load and severity of acute GVHD. However, more evidence is needed for the correlation between microbial composition and GVHD severity.