DysbiosisPhase 4NCT06791993
Impact of Probiotics on Gut Microbiome During Antibiotic Prophylaxis in Elective Orthopedic Surgery
A Phase 4 study testing Probiotic with Human Milk Oligosaccharides (HMO) in people with Dysbiosis and Gut -microbiota, run by Acibadem Maslak Hospital at 6 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dysbiosis, Gut -microbiota, Microbiome Analysis
- What is being tested?
- Probiotic with Human Milk Oligosaccharides (HMO)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 1 Feb 2025to 1 Oct 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged between 18 and 65 years
- Scheduled for elective low-risk orthopedic surgery (carpal tunnel release, A1 pulley release, knee arthroscopic surgery).
Who cannot join
- History of infection or antibiotic use within the last 12 weeks.
- Use of routine probiotics, vitamins, or herbal supplements in the last 4 weeks.
- Known allergy to beta-lactam or cephalosporin antibiotics.
- History of autoimmune disease, uncontrolled systemic disease, or chronic inflammatory conditions (e.g., systemic lupus erythematosus, rheumatoid arthritis).
- History of chronic intestinal diseases such as small intestine bacterial overgrowth (SIBO), irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), or celiac disease.
- Increased risk of infection due to medical comorbidities or use of immunosuppressive drugs.
Trial locations and contacts
6 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 3 countries
Turkey (Türkiye)4 sites
Istanbul University Cerrahpasa
Istanbul, 34098
Halil İbrahim Bulut, Medical Student, +90 506 185 4819, halilibrahim.bulut@ogr.iuc.edu.tr
Halil İbrahim Bulut, Medical Student
Acıbadem International Joint Center
Istanbul, 34457
Göksel Dikmen, Assoc. Prof., +90 505 202 1748, goksel.dikmen@acibadem.com
Vahit Emre Özden, Assoc. Prof., +90 532 336 1464, emre.ozden@acibadem.com
Acibadem LABMED Laboratories
Istanbul, 34752
Mustafa Serteser, Prof. Dr., +90 539 515 3115, Mustafa.Serteser@acibadem.edu.tr
Mustafa Serteser, Prof. Dr.
Acıbadem Mehmet Ali Aydınlar University
Istanbul, 34752
Arda Mavi, Intern Dr., +90 537 852 6215, ardamavimd@gmail.com
Arda Mavi, Intern Dr
United States1 site
Parvizi Surgical Innovation
Philadelphia, Pennsylvania, 19107
Emanuele Chisari, Dr., Ph.D, +1 646 806 8067, chisari.emanuele@gmail.com
Emanuele Chisari, Dr., Ph.D
About this study
Official title: Impact of Probiotics Combined with Antibiotic Prophylaxis on Gut Microbiome Balance in Patients Undergoing Elective Orthopedic Surgery, Double-Blinded Randomized Controlled Trial
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.
Read the detailed description
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.
- Being tested
- Placebo Capsule, Probiotic with Human Milk Oligosaccharides (HMO)
- Keywords
- Gut Microbiome, Intestinal Dysbiosis, Surgical Site Infection, Probiotics, Antibiotic Prophylaxis, Human Milk Oligosaccharides (HMO), Shotgun Metagenomic Sequencing, Short-Chain Fatty Acids (SCFAs)
- Medical subject headings
- Dysbiosis, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo CapsuleDrug
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.
Probiotic with Human Milk Oligosaccharides (HMO)Dietary supplement
Also called Dual-Strain Probiotic
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.
| Study group | Role | What they receive |
|---|---|---|
| Routine Antibiotic Prophylaxis + Placebo | Placebo comparator | This arm receives routine antibiotic prophylaxis with a single dose of intravenous Cefazolin and a placebo capsule to match the probiotic intervention. Receives: Drug: Placebo Capsule |
| Routine Antibiotic Prophylaxis + Probiotics | Experimental | This arm receives routine antibiotic prophylaxis with a single dose of intravenous Cefazolin and a dual-strain probiotic containing Human Milk Oligosaccharides (HMO). Receives: Dietary Supplement: Probiotic with Human Milk Oligosaccharides (HMO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks preoperatively (T0) to 1 month postoperatively (T4).
Secondary outcomes (6)
Firmicutes/Bacteroidetes Ratio
Determine changes in the Firmicutes/Bacteroidetes ratio, a key marker of dysbiosis, between intervention groups. Using shotgun metagenomic sequencing.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 week preoperatively (T1) and 2 weeks postoperatively (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for DysbiosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel group design where participants are randomly assigned to one of two independent arms. One group receives routine antibiotic prophylaxis with a placebo capsule, while the other group receives routine antibiotic prophylaxis combined with a dual-strain probiotic containing Human Milk Oligosaccharides (HMO). The interventions are administered concurrently over the perioperative period to evaluate their effects on gut microbiome balance and patient recovery. Randomization and blinding ensure unbiased comparisons between the groups.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem Maslak Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Acibadem University
- Responsible party
- Sponsor
- Investigators
- Javad Parvizi, Prof. Dr., Study chair, International Joint Center Acibadem, Parvizi Surgical InnovationEmanuele Chisari, Dr., Ph.D., Study director, Parvizi Surgical Innovation, University of Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791993
- Sponsor's protocol ID
- 2024-KAEK-03
- Status last verified
- Jan 2025
- First submitted
- 23 Dec 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
Anthony WE, Wang B, Sukhum KV, D'Souza AW, Hink T, Cass C, Seiler S, Reske KA, Coon C, Dubberke ER, Burnham CD, Dantas G, Kwon JH. Acute and persistent effects of commonly used antibiotics on the gut microbiome and resistome in healthy adults. Cell Rep. 2022 Apr 12;39(2):110649. doi: 10.1016/j.celrep.2022.110649.
PubMed 35417701Rios JL, Bomhof MR, Reimer RA, Hart DA, Collins KH, Herzog W. Protective effect of prebiotic and exercise intervention on knee health in a rat model of diet-induced obesity. Sci Rep. 2019 Mar 7;9(1):3893. doi: 10.1038/s41598-019-40601-x.
PubMed 30846801Akagawa Y, Kimata T, Akagawa S, Yamaguchi T, Kato S, Yamanouchi S, Hashiyada M, Akane A, Kino M, Tsuji S, Kaneko K. Impact of Long-Term Low Dose Antibiotic Prophylaxis on Gut Microbiota in Children. J Urol. 2020 Dec;204(6):1320-1325. doi: 10.1097/JU.0000000000001227. Epub 2020 Jul 2.
PubMed 32614253Huang Z, Chen J, Li B, Zeng B, Chou CH, Zheng X, Xie J, Li H, Hao Y, Chen G, Pei F, Shen B, Kraus VB, Wei H, Zhou X, Cheng L. Faecal microbiota transplantation from metabolically compromised human donors accelerates osteoarthritis in mice. Ann Rheum Dis. 2020 May;79(5):646-656. doi: 10.1136/annrheumdis-2019-216471. Epub 2020 Mar 23.
PubMed 32205337Coulson S, Butt H, Vecchio P, Gramotnev H, Vitetta L. Green-lipped mussel extract (Perna canaliculus) and glucosamine sulphate in patients with knee osteoarthritis: therapeutic efficacy and effects on gastrointestinal microbiota profiles. Inflammopharmacology. 2013 Feb;21(1):79-90. doi: 10.1007/s10787-012-0146-4. Epub 2012 Jul 22.
PubMed 22821424Kullar R, Chisari E, Snyder J, Cooper C, Parvizi J, Sniffen J. Next-Generation Sequencing Supports Targeted Antibiotic Treatment for Culture Negative Orthopedic Infections. Clin Infect Dis. 2023 Jan 13;76(2):359-364. doi: 10.1093/cid/ciac733.
PubMed 36074890Ramires LC, Santos GS, Ramires RP, da Fonseca LF, Jeyaraman M, Muthu S, Lana AV, Azzini G, Smith CS, Lana JF. The Association between Gut Microbiota and Osteoarthritis: Does the Disease Begin in the Gut? Int J Mol Sci. 2022 Jan 27;23(3):1494. doi: 10.3390/ijms23031494.
PubMed 35163417Chisari E, Wouthuyzen-Bakker M, Friedrich AW, Parvizi J. The relation between the gut microbiome and osteoarthritis: A systematic review of literature. PLoS One. 2021 Dec 16;16(12):e0261353. doi: 10.1371/journal.pone.0261353. eCollection 2021.
PubMed 34914764Favazzo LJ, Hendesi H, Villani DA, Soniwala S, Dar QA, Schott EM, Gill SR, Zuscik MJ. The gut microbiome-joint connection: implications in osteoarthritis. Curr Opin Rheumatol. 2020 Jan;32(1):92-101. doi: 10.1097/BOR.0000000000000681.
PubMed 31724973Boer CG, Radjabzadeh D, Medina-Gomez C, Garmaeva S, Schiphof D, Arp P, Koet T, Kurilshikov A, Fu J, Ikram MA, Bierma-Zeinstra S, Uitterlinden AG, Kraaij R, Zhernakova A, van Meurs JBJ. Intestinal microbiome composition and its relation to joint pain and inflammation. Nat Commun. 2019 Oct 25;10(1):4881. doi: 10.1038/s41467-019-12873-4.
PubMed 31653850
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Probiotics Combined with Antibiotic Prophylaxis on Gut Microbiome Balance in Patients Undergoing Elective Orthopedic Surgery, Double-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06791993
- Acronym / sponsor ID
- 2024-KAEK-03
- Keywords
- Gut Microbiome, Intestinal Dysbiosis, Surgical Site Infection, Probiotics, Antibiotic Prophylaxis, Human Milk Oligosaccharides (HMO), Shotgun Metagenomic Sequencing, Short-Chain Fatty Acids (SCFAs)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Acibadem Maslak HospitalUniversity, hospital or other
- Collaborators
- Acibadem University
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study uses a parallel group design where participants are randomly assigned to one of two independent arms. One group receives routine antibiotic prophylaxis with a placebo capsule, while the other group receives routine antibiotic prophylaxis combined with a dual-strain probiotic containing Human Milk Oligosaccharides (HMO). The interventions are administered concurrently over the perioperative period to evaluate their effects on gut microbiome balance and patient recovery. Randomization and blinding ensure unbiased comparisons between the groups.
| Arm | Type | Receives |
|---|---|---|
| Routine Antibiotic Prophylaxis + Placebo | Placebo comparator | Drug: Placebo CapsuleThis arm receives routine antibiotic prophylaxis with a single dose of intravenous Cefazolin and a placebo capsule to match the probiotic intervention. |
| Routine Antibiotic Prophylaxis + Probiotics | Experimental | Dietary Supplement: Probiotic with Human Milk Oligosaccharides (HMO)This arm receives routine antibiotic prophylaxis with a single dose of intravenous Cefazolin and a dual-strain probiotic containing Human Milk Oligosaccharides (HMO). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged between 18 and 65 years
- Scheduled for elective low-risk orthopedic surgery (carpal tunnel release, A1 pulley release, knee arthroscopic surgery).
Key exclusion criteria (6 listed)
- History of infection or antibiotic use within the last 12 weeks.
- Use of routine probiotics, vitamins, or herbal supplements in the last 4 weeks.
- Known allergy to beta-lactam or cephalosporin antibiotics.
- History of autoimmune disease, uncontrolled systemic disease, or chronic inflammatory conditions (e.g., systemic lupus erythematosus, rheumatoid arthritis).
- History of chronic intestinal diseases such as small intestine bacterial overgrowth (SIBO), irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), or celiac disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo CapsuleParticipants 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 | Routine Antibiotic Prophylaxis + Placebo |
| Probiotic with Human Milk Oligosaccharides (HMO)Also: Dual-Strain ProbioticParticipants 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. | Dietary supplement | Routine Antibiotic Prophylaxis + Probiotics |
Primary outcome
Maintenance of Gut Microbiome Balance
Time frame: 2 weeks preoperatively (T0) to 1 month postoperatively (T4).
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.
6 secondary outcomes
Firmicutes/Bacteroidetes Ratio
Time frame: 2 weeks preoperatively (T0) to 1 month postoperatively (T4).
Short-Chain Fatty Acid (SCFA) Production
Time frame: 2 weeks preoperatively (T0) to 1 month postoperatively (T4).
Dysbiosis Index
Time frame: 2 weeks preoperatively (T0) to 1 month postoperatively (T4).
Microbiome health index ( MHI) OR Microbiome health index for post-antiobiotic (MHI- A)
Time frame: 2 weeks preoperatively (T0) to 1 month postoperatively (T4).
WHO-5 Well-being Index
Time frame: 1 week preoperatively (T1) and 2 weeks postoperatively (T3).
EuroQol 5-Dimension (EQ-5D) score.
Time frame: 1 week preoperatively (T1) and 2 weeks postoperatively (T3).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Background: PubMed 35417701Anthony WE, Wang B, Sukhum KV, D'Souza AW, Hink T, Cass C, Seiler S, Reske KA, Coon C, Dubberke ER, Burnham CD, Dantas G, Kwon JH. Acute and persistent effects of commonly used antibiotics on the gut microbiome and resistome in healthy adults. Cell Rep. 2022 Apr 12;39(2):110649. doi: 10.1016/j.celrep.2022.110649.
- Background: PubMed 30846801Rios JL, Bomhof MR, Reimer RA, Hart DA, Collins KH, Herzog W. Protective effect of prebiotic and exercise intervention on knee health in a rat model of diet-induced obesity. Sci Rep. 2019 Mar 7;9(1):3893. doi: 10.1038/s41598-019-40601-x.
- Background: PubMed 32614253Akagawa Y, Kimata T, Akagawa S, Yamaguchi T, Kato S, Yamanouchi S, Hashiyada M, Akane A, Kino M, Tsuji S, Kaneko K. Impact of Long-Term Low Dose Antibiotic Prophylaxis on Gut Microbiota in Children. J Urol. 2020 Dec;204(6):1320-1325. doi: 10.1097/JU.0000000000001227. Epub 2020 Jul 2.
- Background: PubMed 32205337Huang Z, Chen J, Li B, Zeng B, Chou CH, Zheng X, Xie J, Li H, Hao Y, Chen G, Pei F, Shen B, Kraus VB, Wei H, Zhou X, Cheng L. Faecal microbiota transplantation from metabolically compromised human donors accelerates osteoarthritis in mice. Ann Rheum Dis. 2020 May;79(5):646-656. doi: 10.1136/annrheumdis-2019-216471. Epub 2020 Mar 23.
- Background: PubMed 22821424Coulson S, Butt H, Vecchio P, Gramotnev H, Vitetta L. Green-lipped mussel extract (Perna canaliculus) and glucosamine sulphate in patients with knee osteoarthritis: therapeutic efficacy and effects on gastrointestinal microbiota profiles. Inflammopharmacology. 2013 Feb;21(1):79-90. doi: 10.1007/s10787-012-0146-4. Epub 2012 Jul 22.
- Background: PubMed 36074890Kullar R, Chisari E, Snyder J, Cooper C, Parvizi J, Sniffen J. Next-Generation Sequencing Supports Targeted Antibiotic Treatment for Culture Negative Orthopedic Infections. Clin Infect Dis. 2023 Jan 13;76(2):359-364. doi: 10.1093/cid/ciac733.
- Background: PubMed 35163417Ramires LC, Santos GS, Ramires RP, da Fonseca LF, Jeyaraman M, Muthu S, Lana AV, Azzini G, Smith CS, Lana JF. The Association between Gut Microbiota and Osteoarthritis: Does the Disease Begin in the Gut? Int J Mol Sci. 2022 Jan 27;23(3):1494. doi: 10.3390/ijms23031494.
- Background: PubMed 34914764Chisari E, Wouthuyzen-Bakker M, Friedrich AW, Parvizi J. The relation between the gut microbiome and osteoarthritis: A systematic review of literature. PLoS One. 2021 Dec 16;16(12):e0261353. doi: 10.1371/journal.pone.0261353. eCollection 2021.
- Background: PubMed 31724973Favazzo LJ, Hendesi H, Villani DA, Soniwala S, Dar QA, Schott EM, Gill SR, Zuscik MJ. The gut microbiome-joint connection: implications in osteoarthritis. Curr Opin Rheumatol. 2020 Jan;32(1):92-101. doi: 10.1097/BOR.0000000000000681.
- Background: PubMed 31653850Boer CG, Radjabzadeh D, Medina-Gomez C, Garmaeva S, Schiphof D, Arp P, Koet T, Kurilshikov A, Fu J, Ikram MA, Bierma-Zeinstra S, Uitterlinden AG, Kraaij R, Zhernakova A, van Meurs JBJ. Intestinal microbiome composition and its relation to joint pain and inflammation. Nat Commun. 2019 Oct 25;10(1):4881. doi: 10.1038/s41467-019-12873-4.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Javad Parvizi, Prof. Dr. study chair
International Joint Center Acibadem, Parvizi Surgical Innovation
Emanuele Chisari, Dr., Ph.D. study director
Parvizi Surgical Innovation, University of Groningen
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Probiotic with Human Milk Oligosaccharides (HMO) in people with Dysbiosis and Gut -microbiota, run by Acibadem Maslak Hospital at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Turkey (Türkiye), United States, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact İbrahim Tuncay, Prof. Dr. (+90 212 304 43 78, ituncay@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maintenance of Gut Microbiome Balance (time frame: 2 weeks preoperatively (T0) to 1 month postoperatively (T4).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06791993, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.