Work

Patient-reported benefits of colonoscopicallyadministered microbiota restoration therapy: a qualitative study of adult patients with recurrent Clostridioides difficile infection

Year: 2025

Type: article

Abstract: Background: ) is approved by the FDA to reduce CDI recurrence. While the burden of rCDI is well established, less is known about the patient experience after RBL treatment and its impact on HRQoL. Objectives: To explore the burden of rCDI on HRQoL, and any improvements in symptoms and impacts after RBL administration by colonoscopy. Design: A qualitative sub-study embedded in the CDI-SCOPE phase IIIb clinical trial (NCT05831189). Methods: Qualitative interviews were conducted with 30 trial participants approximately 8 weeks after RBL treatment. Interviews were conducted using a semi-structured discussion guide; they were audio-recorded, transcribed verbatim, and thematically analyzed. Results: Thirty of 41 trial participants (73%) took part in the qualitative interviews (July 2023-September 2024). Participants (mean age 59 years; 87% female) had experienced multiple prior rCDI episodes. Before RBL treatment, participants reported severe symptoms, including diarrhea (30/30; 100%), abdominal pain (21/30; 70%), and fatigue (14/30; 47%), which negatively affected daily life, social interactions, and emotional health. Eight weeks after RBL treatment, no participants reported a recurrence. Diarrhea symptoms resolved (17/30; 57%) or improved (13/30; 43%) for all participants, typically within 1 month. Average severity scores for diarrhea declined markedly (from 8.9 to 1.3). Every participant (100%) reported improved ability to engage in daily activities; nearly all (29/30; 97%) described positive changes to social life/relationships, and 77% (23/30) reported improved emotional well-being. Conclusion: RBL administered via colonoscopy provided rapid, meaningful relief from rCDI symptoms, and due to symptom improvements, many participants reported that they were able to resume daily life. These findings highlight the broader value of RBL in restoring HRQoL and overall well-being. Trial registration: ClinicalTrials.gov: NCT05831189.

Source: Therapeutic Advances in Gastroenterology

DOI: 10.1177/17562848251392102