Impact of Gut Microbiota and Tryptophan Metabolites on Acute Pain in Lumbar Disc Herniation Surgery Patients

NCT ID: NCT06502223

Last Updated: 2024-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-12

Study Completion Date

2023-03-15

Brief Summary

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It is well-established that the gut microbiota plays a crucial role in various pain mechanisms, including visceral pain, inflammatory pain, headache, neuropathic pain, and opioid tolerance. Changes in the gut microbiome can alter pain perception. In our study, The investigator investigated the effects of microbiota alterations and the associated tryptophan metabolites on acute pain using the Visual Analog Scale (VAS).

Detailed Description

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The study included patients aged 18 and above undergoing lumbar disc herniation surgery. Blood samples were collected preoperatively, at 8 hours, and at 24 hours postoperatively to analyze tryptophan metabolites (picolinic acid, 3- Hydroxykynurenine, anthranilic acid, kynurenine, quinolinic acid, kynurenic acid, xanthurenic acid). Concurrent VAS pain assessments were conducted, and correlations between tryptophan metabolites and VAS were evaluated.

Conditions

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Microbial Substitution Tryptophan Metabolism Alterations Postoperative Pain, Acute

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Pain Perception in Patients Undergoing Lumbar Disc Herniation Surgery

Analyze tryptophan metabolites (picolinic acid, 3- Hydroxykynurenine, anthranilic acid, kynurenine, quinolinic acid, kynurenic acid, xanthurenic acid). Concurrent VAS pain assessments were conducted, and correlations between tryptophan metabolites and VAS were evaluated.

Intervention Type PROCEDURE

Other Intervention Names

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Microbiota and Associated Blood Tryptophan Metabolites on

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing lumbar disc herniation surgery at Dokuz Eylül University Hospital.
* Patients who have read and consented to the informed consent form for the study.
* Age 18 years or older.
* Surgery duration exceeding 2 hours.

Exclusion Criteria

* Patients are unwilling to participate in the study.
* Surgery duration less than 2 hours.
* Patients under the age of 18.
* Patients with a history of abdominal surgery.
* Patients who received antibiotic therapy for intestinal pathology within the last 3 weeks.
* Patients with known abdominal pathologies suspected to alter the microbial flora (e.g., Crohn's disease, ulcerative colitis, celiac disease).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dokuz Eylul University

OTHER

Sponsor Role lead

Responsible Party

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Yunus Çelik, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yunus Celik, M.D.

Role: STUDY_CHAIR

Dokuz Eylül University Hospital, Faculty of Medicine

Locations

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Yunu Çelik

Izmir, Balçova, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Celik Y, Aksu H, Gunenc FS, Kalemci O, Kizmazoglu C, Keskinoglu P. Association between circulating tryptophan metabolites and postoperative pain intensity in lumbar disc herniation surgery: An observational study. Medicine (Baltimore). 2025 Aug 1;104(31):e43704. doi: 10.1097/MD.0000000000043704.

Reference Type DERIVED
PMID: 40760513 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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DEU-Çelik001

Identifier Type: -

Identifier Source: org_study_id

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