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New treatment option for Hip Osteoarthritis
Official title Preoperative Fasting and the Gut Microbiome Before Hip Replacement
ClinicalTrials.gov ID: NCT07651462
What this study is testing
- What it's testing
- Postoperative complications occur in 5-15% of patients undergoing elective primary total hip arthroplasty (THA), including periprosthetic joint infection (PJI), thrombosis, wound healing disorders, and metabolic dysregulation. The gut microbiome and the systemic immune profile have both been implicated as modifiable contributors to perioperative complication risk.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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 assigned by chance to the fasting arm) or willing to be assigned by...
You likely can't join if
- 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)
See the full eligibility 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 assigned by chance to the fasting arm) or willing to be assigned by chance to either arm
- 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 treatment drug or device trial
- Pregnancy or breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- Berlin, State of Berlin, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berlin, State of Berlin, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.