Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Jan;42(1):490-499.
doi: 10.1007/s12325-024-03065-8. Epub 2024 Nov 28.

Patient Satisfaction Scale Following a Laxative for Antibiotic Washout Prior to Oral Microbiome Therapy

Hubert C Chua  1 , Sissi Pham  2 , David A Lombardi  3 , Edina Hot  4 , Lorie Mody  5
Affiliations

Patient Satisfaction Scale Following a Laxative for Antibiotic Washout Prior to Oral Microbiome Therapy

Hubert C Chua et al. Adv Ther. 2025 Jan.

Abstract

Introduction: Administration of fecal microbiota spores, live-brpk [Vowst Oral Spores (VOS)], an oral microbiome therapeutic approved for prevention of recurrent Clostridioides difficile infection in adults, requires antibiotic washout using a laxative prior to administration. Patient acceptability of the prerequisite laxative is important. This study assessed psychometric properties of the Antibiotic Washout Patient Satisfaction Scale (AWPSS) which was minimally modified from a previously validated patient satisfaction scale for bowel preparation prior to colonoscopy.

Methods: Patients from the ECOSPOR IV trial who received a laxative preparation prior to oral administration of VOS and were administered the AWPSS were included. Reliability and construct validity of the AWPSS were evaluated.

Results: AWPSS data were available for 110 patients; all completed all 6 items of the AWPSS, supporting its acceptability. Domain 1 mean/median transformed total scores of 105.9/100 [range (best-worst), 0-300] suggested that patients were satisfied with the laxative preparation; a Cronbach's alpha of 0.81 showed acceptable reliability. Almost all patients (97.3%) reported they were able to consume the entire laxative solution as instructed and would take it again if needed (95.5%). Higher satisfaction with the laxative preparation predicted higher acceptability of future use if needed (lower score) with mean/median of 101.7/100 and 195.0/200.00 for those who were willing or not willing to accept, respectively (P = 0.008).

Conclusions: AWPSS is a valid and reliable 6-item patient-reported outcome measure for use in patients requiring a laxative prior to oral microbiome therapy. AWPSS showed antibiotic washout was well tolerated and predicted that patients would be willing to consume the laxative in the future if needed.

Keywords: Antimicrobial stewardship; Antimicrobial susceptibility; Patient satisfaction; Patient-reported outcome; Quality of life.

PubMed Disclaimer

Conflict of interest statement

Declarations. Conflict of Interest: Hubert C. Chua and David A. Lombardi none were declared. Sissi Pham and Lorie Mody are consultants to Nestlé Heath Science. Edina Hot is an employee of Nestlé Health Science. Ethical Approval: The survey described in this manuscript was part of Study SERES-013, an open-label extension of Study-012, was approved by investigational review boards and participants provided written informed consent.

Figures

Fig. 1
Fig. 1
The AWPSS. Adapted with permission from the author of the original survey for colonoscopy which was published in Hatoum 2016 et al. [19]
Fig. 2
Fig. 2
Domain 1: item analysis; Ease of consumption was rated as very easy, easy, tolerable, difficult, very difficult; Overall experience was rated as excellent, good, fair, poor, bad; Taste was rated as excellent, good, tolerable, poor, bad
Fig. 3
Fig. 3
Item 2/Domain 2 (Items 5 and 6) analyses
See this image and copyright information in PMC

References

    1. CDC. Clostridioides Difficile Infection (CDI) tracking. Last reviewed: February 24, 2022. https://www.cdc.gov/hai/eip/cdiff-tracking.html. Accessed Feb 2, 2024.
    1. Centers for Disease Control and Prevention (CDC). Antibiotic resistance threats in the United States 2019. Revised: December 2019. https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-re.... Accessed Feb 2, 2024.
    1. Kwon J, Olsen M, Dubberke E. The morbidity, mortality, and costs associated with clostridium difficile infection. Infect Dis Clin. 2015;29:123–34. - PubMed
    1. UK Health Security Agency. Thirty-day all-cause mortality following MRSA, MSSA and gram-negative bacteraemia and C. difficile infections, 2020 to 2021. London, UK: UK Health Security Agency; 2021.
    1. Sims MD, Khanna S, Feuerstadt P, et al. Safety and tolerability of SER-109 as an investigational microbiome therapeutic in adults with recurrent Clostridioidesdifficile infection: a phase 3, open-label, single-arm trial. JAMA Netw Open. 2023;6(2): e2255758. - PMC - PubMed

LinkOut - more resources