Probiotics for Gut Microbiome Imbalance

Recruiting at 5 trial locations

Overseen By İbrahim Tuncay, Prof. Dr.

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Acibadem Maslak Hospital

Must be taking: Antibiotics

Must not be taking: Immunosuppressive drugs

Disqualifiers: Autoimmune, Chronic intestinal, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used antibiotics, probiotics, vitamins, or herbal supplements recently. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Probiotic with Human Milk Oligosaccharides (HMO) for gut microbiome imbalance?

Research shows that combining Bifidobacterium longum subspecies infantis (a type of beneficial bacteria) with human milk oligosaccharides (HMOs) can help restore a healthy balance in the gut microbiome by increasing beneficial bacteria and altering gut metabolites. This combination has been shown to improve gut health in both healthy adults and those with gut imbalances, suggesting it may be effective for treating gut microbiome imbalance. ^{1 2 3 4 5}

Is the use of probiotics with human milk oligosaccharides (HMO) safe for humans?

Research shows that human milk oligosaccharides (HMOs) are generally safe for humans, as they have been well tolerated in both healthy adults and infants. Studies have shown no adverse effects when HMOs are used in various formulations, including with probiotics, in both adults and infants. ^{2 3 6 7 8}

How does the probiotic treatment for gut microbiome imbalance differ from other treatments?

This treatment uses human milk oligosaccharides (HMOs) to specifically promote the growth of beneficial bacteria like Bifidobacterium in the gut, which is different from other treatments that may not target specific bacteria. HMOs are unique because they are complex sugars found in human milk that can modulate the gut microbiome and immune function, offering a novel approach to restoring gut balance. ^{3 9 10 11 12}

What is the purpose of this 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.

Research Team

Javad Parvizi, Prof. Dr.

Principal Investigator

International Joint Center Acibadem, Parvizi Surgical Innovation

Emanuele Chisari, Dr., Ph.D.

Principal Investigator

Parvizi Surgical Innovation, University of Groningen

Eligibility Criteria

This trial is for patients undergoing elective orthopedic surgery who will receive antibiotics to prevent infection. It's designed to see if probiotics can keep their gut bacteria balanced during treatment. People with conditions that might affect the study or those on other treatments affecting gut health are not eligible.

Inclusion Criteria

I am scheduled for a minor orthopedic surgery.

Exclusion Criteria

Known allergy to beta-lactam or cephalosporin antibiotics

I have used probiotics, vitamins, or herbal supplements in the last 4 weeks.

I have an autoimmune or chronic inflammatory condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Participants receive routine antibiotic prophylaxis and either probiotics or placebo 2 weeks before surgery

2 weeks

1 visit (in-person)

Perioperative

Participants undergo elective orthopedic surgery with continued administration of antibiotics and probiotics/placebo

1 week

1 visit (in-person)

Postoperative

Participants continue receiving probiotics/placebo and are monitored for gut microbiome balance and overall well-being

1 month

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Probiotic with Human Milk Oligosaccharides (HMO)

Trial Overview The study tests whether a probiotic capsule containing Human Milk Oligosaccharides (HMO) can protect the gut microbiome from disruption typically caused by antibiotics given during surgery, compared to a placebo.

Participant Groups

Group I: Routine Antibiotic Prophylaxis + Probiotics Experimental Treatment 1 Intervention

This arm receives routine antibiotic prophylaxis with a single dose of intravenous Cefazolin and a dual-strain probiotic containing Human Milk Oligosaccharides (HMO).

Group II: Routine Antibiotic Prophylaxis + Placebo Placebo Group 1 Intervention

This arm receives routine antibiotic prophylaxis with a single dose of intravenous Cefazolin and a placebo capsule to match the probiotic intervention.

Who Is Running the Clinical Trial?

Acibadem Maslak Hospital

Lead Sponsor

Trials

4

Recruited

2,400+

Acibadem University

Collaborator

Trials

171

Recruited

44,700+

References

1. United States pubmed.ncbi.nlm.nih.gov

Precision modulation of dysbiotic adult microbiomes with a human-milk-derived synbiotic reshapes gut microbial composition and metabolites. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Dosing a synbiotic of human milk oligosaccharides and B. infantis leads to reversible engraftment in healthy adult microbiomes without antibiotics. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Human milk oligosaccharides modulate the intestinal microbiome of healthy adults. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

A meta-analysis on the efficacy of probiotics for maintenance of remission and prevention of clinical and endoscopic relapse in Crohn's disease. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The Effects of Human Milk Oligosaccharides on Gut Microbiota, Metabolite Profiles and Host Mucosal Response in Patients with Irritable Bowel Syndrome. [2021]

6. England pubmed.ncbi.nlm.nih.gov

In vitro measurement of the impact of human milk oligosaccharides on the faecal microbiota of weaned formula-fed infants compared to a mixture of prebiotic fructooligosaccharides and galactooligosaccharides. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

2'-Fucosyllactose Is Well Tolerated in a 100% Whey, Partially Hydrolyzed Infant Formula With Bifidobacterium lactis: A Randomized Controlled Trial. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Human milk oligosaccharide supplementation in irritable bowel syndrome patients: A parallel, randomized, double-blind, placebo-controlled study. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Human Milk Oligosaccharide Concentrations Are Associated with Multiple Fixed and Modifiable Maternal Characteristics, Environmental Factors, and Feeding Practices. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Bifidobacterium catabolism of human milk oligosaccharides overrides endogenous competitive exclusion driving colonization and protection. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Oral supplementation of healthy adults with 2'-O-fucosyllactose and lacto-N-neotetraose is well tolerated and shifts the intestinal microbiota. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Human milk oligosaccharide consumption by probiotic and human-associated bifidobacteria and lactobacilli. [2023]