A phase 2 clinical trial explored the use of fecal microbiota transplantation (FMT) with an anaerobic cultivated human intestinal microbiome (ACHIM) to alleviate gastrointestinal (GI) symptoms in patients with systemic sclerosis. While ACHIM was well-tolerated, it did not demonstrate significant improvement over placebo in reducing GI symptoms. The study highlights the need for further research to optimize FMT strategies for this patient population.
A recent phase 2 clinical trial investigated the efficacy of fecal microbiota transplantation (FMT) using an anaerobic cultivated human intestinal microbiome ( ACHIM ) in alleviating gastrointestinal (GI) symptoms experienced by patients with systemic sclerosis . The trial enrolled 67 participants with moderate to severe lower GI tract symptoms and randomized them to receive either ACHIM or a placebo through repeated upper intestinal infusions.
The primary outcome measured was the change in the most bothersome lower GI tract symptom from the baseline to week 12, using the University of California, Los Angeles Scleroderma Clinical Trials Consortium Gastrointestinal Tract 2.0 scoring system. Safety assessments were conducted at weeks 0, 2, 4, 6, and 12 for all participants who received at least one infusion.The results indicated that ACHIM was well-tolerated by the patients with systemic sclerosis. However, no significant improvement in GI symptoms was observed compared to the placebo group. The average marginal effect (AME) for the change in the worst lower GI tract symptom from baseline to week 12 was 0.20 for the ACHIM group, which was not statistically different from the placebo group. A subgroup analysis, focusing on participants with disease duration less than 3 years, revealed a trend toward improvement with ACHIM compared to placebo (AME, -0.70). While adverse events were reported by both groups, most were mild and transient.Microbiota analysis demonstrated an increased abundance of specific bacterial species in the ACHIM group compared to the placebo group. However, there were no significant differences in microbial alpha and beta diversity between the groups. The researchers acknowledged that the study's design may have contributed to the lack of significant findings. They suggested that focusing on a predominant GI symptom experienced by systemic sclerosis patients and tailoring the FMT to the most affected site could yield more promising results. Despite the limitations, the study authors remain optimistic about the potential of FMT for treating GI symptoms in systemic sclerosis patients with further refinement of trial design.
Fecal Microbiota Transplantation Systemic Sclerosis Gastrointestinal Symptoms ACHIM Clinical Trial
United States Latest News, United States Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Fecal Microbiota Transplantation Shows Promise for Type 1 Diabetes Gastrointestinal IssuesA new study suggests that fecal microbiota transplantation (FMT) can alleviate gastrointestinal problems in people with type 1 diabetes. Researchers at Aarhus University Hospital in Denmark found that FMT significantly reduced gastrointestinal symptoms in participants compared to a placebo group, with no major complications.
Read more »
Fecal Microbiota Transplant: A Promising Treatment for Hepatic EncephalopathyThis article explores the debilitating effects of hepatic encephalopathy (HE) and discusses the potential of fecal microbiota transplantation (FMT) as a revolutionary treatment for this condition. The article details the role of the gut microbiome in HE, explaining how imbalances can lead to ammonia buildup in the brain. It contrasts traditional approaches like antibiotics and probiotics with the efficacy of FMT, highlighting its ability to restore gut health and alleviate HE symptoms.
Read more »
Postdoc (all genders) on microbiota-host interaction incancer - Hamburg (DE) job with Personalwerk GmbHPostdoc (all genders) on microbiota-host interaction in cancer Full time/ Part time | Temporary | Arbeitsort: Hamburg Eppendorf UKE_Zentrum für Onkologie Better together. For life.
Read more »
Gut Microbiota and Obesity: The Role of Carbohydrate SalvageThis article explores the connection between the gut microbiota and obesity, focusing on the process of carbohydrate salvage. It explains how bacteria in the gut metabolize carbohydrates, produce energy, and influence energy balance. The article highlights the altered gut microbiota composition in obesity and its impact on signaling molecules involved in energy homeostasis.
Read more »
Fecal Hemoglobin Levels in Previous FITs Predict Colorectal Neoplasia RiskA new meta-analysis reveals that higher fecal hemoglobin (f-Hb) concentrations in previous fecal immunochemical tests (FITs), especially in those with negative results, significantly increase the risk of detecting colorectal neoplasia in subsequent screenings. The findings support the development of risk-stratified screening strategies based on f-Hb levels, potentially improving early detection and personalized patient care.
Read more »
Oral Microbiome Dysbiosis: Biomarker for Upper GI Disorders?Changes in oral microbiota were associated with precancerous lesions and disorders of the upper gastrointestinal tract in a population-based study.
Read more »