A study on the efficacy and safety of fecal microbiota transplantation as an adjunctive therapy for treating depressive episodes
Abstract
This study aimed to evaluate the efficacy and safety of fecal microbiota transplantation (FMT) as an adjunctive therapy for depressive episodes. This study recruited 46 participants aged 18–65 from January 2022 to December 2023 who were diagnosed with depression according to the International Classification of Diseases, 10th edition. They were randomly divided into two groups to receive different treatments, including FMT combined with medication group (test group, n = 23) and the medication-only group (control group, n = 23). Assessments were performed before and two weeks after treatment. Ten predominant gut microbiota species were analyzed, and the Hamilton’s Depression Scale-24(HAMD-24) was used to evaluate depressive symptoms. Adverse events related to treatment were assessed using an adverse event scale and laboratory tests. The main evaluation indicators included the reduction rate of HAMD-24 scores, treatment efficacy rate, and changes in the indicators of the ten predominant intestinal bacteria before and after transplantation. Safety assessment indicators included adverse events, blood routine, biochemistry, electrocardiogram, immunological parameters (immunoglobulins and complement), hypersensitive C-reactive protein(hs-CRP), thyroid function, and glycated hemoglobin. The rank-sum test was performed to compare differences in microbiota before and after FMT treatment. The relationship between gut microbiota and depression severity was examined by means of…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 46 participants or records.
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