Sabine Hazan, MD1, Jordan Daniels, MS1, Adriana Vidal, PhD1, Ross Peterson, PhD2, Anthony Clark, PhD2 1ProgenaBiome, Ventura, CA; 2Helaina Inc, New York, NY Introduction: Balance in the gut microbiome is a critically important component of human health, helping preserve its myriad functions such as immune modulation and nutrient availability. When this balance shifts to dysbiosis, disease and gastrointestinal symptoms can occur. In this study, we sought to determine the impact of effera™ Human Lactoferrin supplementation on the gut microbiome composition and relative abundance. Individuals with Inflammatory Bowel Syndrome (IBS) are at increased risk of developing dysbiosis and gastrointestinal symptoms, and as such were selected as subjects for this study. Methods: Stool samples were collected from 21 individuals with a history of IBS were collected before and one week after oral supplementation with effera™ Human Lactoferrin (100 mg daily). The subjects also kept diaries of their symptoms during the study and were called after completion to assess symptom changes. The stool samples were processed for DNA extraction and normalization, followed by library preparation using shotgun methodology, indexing, and next-generation sequencing. The resulting FASTQ files were analyzed for composition and relative abundance using the OneCodex bioinformatics pipeline and a paired t-test was used to determine statistical significance. Results: Of the ten genera studied, Clostridium was found to be decreased overall in the post-treatment sample set (p< 0.05). Following treatment 41% (n=9) of subjects reported an improvement in gastrointestinal symptoms, 32% (n=7) reported no improvement, and 27% (n=6) were lost to follow up. Discussion: In our study, effera™ Human Lactoferrin supplementation was associated in an overall reduction in abundance of genus Clostridium. C. difficile is a frequent occurrence among those with IBS due to the frequent use of antibiotics, which cause disruption in the normal regulatory presence of commensal microbes. A supplementation approach to helping the gut microbiome is gravely needed to help these individuals with gastrointestinal symptoms. While further study is also needed, this finding may be important for the future in controlling more specifically C. difficile.
Disclosures: Sabine Hazan: Progenabiome – Owner/Ownership Interest. Jordan Daniels indicated no relevant financial relationships. Adriana Vidal indicated no relevant financial relationships. Ross Peterson indicated no relevant financial relationships. Anthony Clark indicated no relevant financial relationships.
Sabine Hazan, MD1, Jordan Daniels, MS1, Adriana Vidal, PhD1, Ross Peterson, PhD2, Anthony Clark, PhD2. P5584 - Effect of Effera™ (Human-Equivalent Lactoferrin) Supplementation on the Human Gut Microbiome in Individuals With IBS, ACG 2025 Annual Scientific Meeting Abstracts. Phoenix, AZ: American College of Gastroenterology.
