A Phase 4 interventional study of Placebo Capsule and Probiotic with Human Milk Oligosaccharides (HMO) in Dysbiosis, Gut -microbiota and Microbiome Analysis, sponsored by Acibadem Maslak Hospital. Not yet recruiting at 6 sites in 3 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-24.
Sponsored by Acibadem Maslak Hospital · Phase 4, Interventional, and Prevention
This study aims to evaluate whether probiotics can help maintain a healthy gut microbiome in patients receiving prophylactic antibiotics during elective orthopedic surgery. Antibiotics, while effective in preventing infections, can disrupt the balance of gut bacteria, leading to dysbiosis. The study hypothesizes that the use of probiotics during the perioperative period can prevent or reduce this disruption, supporting gut health and overall well-being. The research seeks to answer whether combining probiotics with routine antibiotic prophylaxis can preserve gut microbiome balance and improve patient outcomes.
This double-blinded, randomized controlled trial aims to evaluate the effect of probiotics on maintaining gut microbiome balance in patients undergoing elective orthopedic surgery who receive routine prophylactic antibiotics. Antibiotics, while essential for reducing the risk of surgical site infections, are known to disrupt gut microbiota, leading to dysbiosis, an imbalance in microbial composition. Dysbiosis can compromise gut health, reduce microbial diversity, and impair metabolic functions essential for recovery.
The study explores whether a dual-strain probiotic with Human Milk Oligosaccharides (HMO) can prevent or minimize dysbiosis during the perioperative period. By comparing patients receiving routine antibiotics alone with those receiving antibiotics plus probiotics, this trial seeks to identify if probiotics can preserve gut microbial diversity and function.
To assess the impact, fecal samples collected at specific time points will undergo detailed microbiome analysis, including metrics such as microbial richness, diversity, and such. Secondary measures will evaluate the broader effects on patient well-being during the recovery period.
This study is designed to provide evidence for the potential role of probiotics as an adjunct therapy to maintain gut health during antibiotic use, offering a novel approach to improving post-surgical recovery and patient outcomes.
196 studies on the registry are indexed under Dysbiosis; 62 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 140 interventional studies indexed under Dysbiosis.
Browse Dysbiosis studies →This is the only study on the registry with Acibadem Maslak Hospital as lead sponsor.
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This arm receives routine antibiotic prophylaxis with a single dose of intravenous Cefazolin and a placebo capsule to match the probiotic intervention.
Drug: Placebo Capsule
This arm receives routine antibiotic prophylaxis with a single dose of intravenous Cefazolin and a dual-strain probiotic containing Human Milk Oligosaccharides (HMO).
Dietary Supplement: Probiotic with Human Milk Oligosaccharides (HMO)
Participants will receive an inert placebo capsule that matches the probiotic capsule in size, shape, and color. The placebo will be administered orally twice daily, starting 2 weeks before surgery and continuing for 2 weeks postoperatively.
Drug pages: Probiotic · Human milk oligosaccharides
Participants will receive a dual-strain probiotic containing Human Milk Oligosaccharides (HMO) in capsule form. The probiotic will be administered orally twice daily, starting 2 weeks before surgery and continuing for 2 weeks postoperatively.
Also known as: Dual-Strain Probiotic
Maintenance of Gut Microbiome Balance
Evaluate whether probiotic administration preserves gut microbiome balance during the perioperative period by assessing changes in microbial richness, diversity, and evenness. Shotgun metagenomic sequencing analysis will be used to measure microbial composition and diversity.
Time frame: 2 weeks preoperatively (T0) to 1 month postoperatively (T4).
Firmicutes/Bacteroidetes Ratio
Determine changes in the Firmicutes/Bacteroidetes ratio, a key marker of dysbiosis, between intervention groups. Using shotgun metagenomic sequencing.
Time frame: 2 weeks preoperatively (T0) to 1 month postoperatively (T4).
Short-Chain Fatty Acid (SCFA) Production
Assess changes in SCFA production (e.g., acetate, butyrate) as indicators of gut health and microbiome function. Using SCFA quantification through microbiome metabolite analysis.
Time frame: 2 weeks preoperatively (T0) to 1 month postoperatively (T4).
Dysbiosis Index
Dysbiosis Index is the ratio of the total number of Proteobacteria strains divided by total overall bacteria strain
Time frame: 2 weeks preoperatively (T0) to 1 month postoperatively (T4).
Microbiome health index ( MHI) OR Microbiome health index for post-antiobiotic (MHI- A)
Microbiome Health Index (MHI-A) calculated via microbiome analysis. MHI-A is a biomarker and a quantitative measure method of post-antibiotic dysbiosis and subsequent restoration. Higher MHI-A means higher healthy microbiome with low antibiotic resistance gene. Lower MHI- A mean dysbiosis, high antiobiotic resistance gene
Time frame: 2 weeks preoperatively (T0) to 1 month postoperatively (T4).
WHO-5 Well-being Index
The WHO-5 Well-Being Index (The World Health Organization-Five Well-Being Index) is a self-report instrument measuring mental well-being. It consists of five statements relating to the past two weeks. Each statement is rated on a 6-point scale (0,1,2,3,4,5), with higher scores indicating better mental well-being. The raw score is calculated by totalling the scores on each of the five questions. Theraw score ranges from zero to 25, zero representing worst possible mental well-beingand 25 representing best possible mental well-being. To get a percentage score ranging from zero to 100, the raw score is multiplied by four. A percentage score of zero represents worst possible mental well-being; a score of 100 represents best possible mental well-being
Time frame: 1 week preoperatively (T1) and 2 weeks postoperatively (T3).
EuroQol 5-Dimension (EQ-5D) score.
EuroQol 5-Dimension (EQ-5D) score (EQ-5D) descriptive system comprises the same five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION), beach dimension having five response levels:no problems, slight problems, moderateproblems, severe problems, unable to/extreme problems. The respondent is asked to indicate his/her health state by checking the box next to the most appropriate response level for each of the five dimensions. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. For instance, 'slight problems' (e.g. 'I have slight problems in walking about') is always coded as '2'. The digits for the five dimensions can be combined in a 5-digit code that describes the respondent's health state; for instance, 21111 means slight problems in the mobility dimension and no problems in any of the other dimensions
Time frame: 1 week preoperatively (T1) and 2 weeks postoperatively (T3).
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 3 months and ending 5 years following article publication
Access criteria: Data access will be granted to researchers who provide a methodologically sound proposal. Proposals should be directed to goksel.dikmen@acibadem.com To gain access, data requestors will need to sign a data access agreement.
Data sharing details ↗ · www.drive.google.com
Start is estimated for Feb 2025; primary completion for Aug 2025, 6 months later.
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Studies of the drugs tested here: Probiotic · Human milk oligosaccharides