Preoperative Fasting to Shape the Gut with Hip Replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In adults scheduled for elective primary hip replacement, researchers compare a structured 20-day fasting program (Buchinger fasting plus intermittent fasting) to standard preoperative care. The study looks at two main outcomes: a proinflammatory marker in the blood (IL-8) and gut microbial diversity, measured after surgery. Secondary analyses explore broader immune and microbiome changes, metabolic indicators, and postoperative recovery. The design is a single-center, randomized, open-label, two-arm trial with stratification by metabolic health and 130 planned participants.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults aged 18-75 years (inclusive)
* Scheduled for elective primary total hip arthroplasty (THA)
* Able and willing to provide written informed consent
* Able to follow the 20-day preoperative fasting protocol independently at home (if randomized to the fasting arm) or willing to be randomized to either arm

Exclusion Criteria:

* Resorption disorder due to bowel disease (e.g. inflammatory bowel disease, short-bowel syndrome, active celiac disease)
* Antibiotic therapy within the last 2 months before baseline (T0)
* Probiotic, prebiotic, or symbiotic supplementation within the last 2 months before baseline (T0)
* Inability or unwillingness to provide informed consent
* Severe comorbidity precluding fasting (e.g. ASA ≥ IV, advanced renal/hepatic impairment, eating disorder)
* BMI \< 18.5 kg/m² (underweight)
* Concurrent participation in another interventional drug or device trial
* Pregnancy or breastfeeding

Where it's running

• Centrum für Muskuloskeletale Chirurgie (CMSC), Charité - Universitätsmedizin Berlin
  Berlin, State of Berlin, Germany Recruiting

Study contacts

• Study coordinator: Nele Wagener, Dr. med.
• Email: nele.wagener@charite.de
• Phone: +49 30 450 615076

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.