The EBJIS definition of periprosthetic joint infection.
Martin McNally, Ricardo Sousa, Marjan Wouthuyzen-Bakker...
https://pubmed.ncbi.nlm.nih.gov/33380199/Actively Recruiting
Led by Charite University, Berlin, Germany · Updated on 2026-06-22
130
Participants Needed
1
Research Sites
17 weeks
Total Duration
This research evaluates whether a structured 20-day preoperative fasting program affects inflammation and gut microbiome diversity in adults undergoing elective primary total hip arthroplasty THA. The study focuses on reducing plasma IL-8, a proinflammatory marker, and increasing gut microbial alpha-diversity compared to standard care. It also considers effects on other immune markers, metabolic measures, patient-reported outcomes, and postoperative complications. Participants are randomly assigned to either a fasting group or a standard care group. The fasting intervention includes alternating 5-day cycles of the Buchinger Fastenbox, a low-carbohydrate vegetable broth diet, and intermittent fasting, self-administered at home with study supervision. The control group receives usual preoperative care without fasting or supplements. Both groups undergo continuous glucose monitoring and regular weight, waist circumference, and blood pressure measurements before surgery. During the study, stool and blood samples are collected before fasting begins, just before surgery, and at several points after surgery to analyze immune cells, cytokines, and gut microbiome changes. Participants complete questionnaires on diet, infection symptoms, and joint health. Follow-up occurs up to six months post-surgery to assess recovery, complications, and metabolic outcomes. The study aims to enroll 130 adults aged 18 to 75 years.
CONDITIONS
Preoperative Fasting and the Gut Microbiome Before Hip Replacement
N
Nele Wagener, Dr. med.
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Charite University, Berlin, Germany
Lead Sponsor
Schulthess Klinik
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 20 days
Participants either follow a 20-day fasting schedule at home with cycles of a special vegetable broth and intermittent fasting or receive standard preoperative care without fasting. Daily monitoring of ketones, weight, waist circumference, and blood pressure occurs during this period.
Daily self-monitoring
Duration - Up to 6 months post-surgery
Participants undergo hip replacement surgery. Blood and stool samples are collected before surgery and at several points after surgery to measure immune markers and gut microbiome changes. Questionnaires on infection symptoms and joint health are completed during follow-up.
Multiple visits for sample collection and questionnaires
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/19805654/Charite University, Berlin, Germany
Lead Sponsor
Schulthess Klinik
Collaborating Sponsor