UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052053 |
|---|---|
| Receipt number | R000059413 |
| Scientific Title | An exploratory prospective observational study on the effects of gut microbiota and diet on acute postoperative pain. |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2025/03/13 17:36:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
An exploratory prospective observational study on the effects of gut microbiota and diet on acute postoperative pain.
Acronym
An exploratory prospective observational study on the effects of gut microbiota and diet on acute postoperative pain.
Scientific Title
An exploratory prospective observational study on the effects of gut microbiota and diet on acute postoperative pain.
Scientific Title:Acronym
An exploratory prospective observational study on the effects of gut microbiota and diet on acute postoperative pain.
Region
| Japan |
Condition
Condition
rotator cuff injury
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
i)The association between gut microbiota and postoperative acute pain in patients undergoing surgery under general anaesthesia.
ii)The relationship between diet as a background factor for gut microbiota and post-operative acute pain.
The aim is to clarify the above two points.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intestinal bacterial alpha diversity (Shannon Index)
Key secondary outcomes
Analgesic use in the first post-operative week, length of hospital stay, analgesic use in the first post-operative month, post-operative nausea and vomiting, gut bacterial composition, gut bacterial metabolites
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Female
Key inclusion criteria
Adult patients aged 18 years or older undergoing specoscopic shoulder joint surgery under general anaesthesia at Chiba University Hospital, female patients who cooperated in the questionnaire survey and gave consent to submit a stool specimen.
Key exclusion criteria
Patients with chronic inflammatory diseases such as rheumatoid arthritis
Patients with chronic pain
Patients using strong opioids before surgery
Patients who received antibiotics within 1 month
Patients under 18 years of age
Non-consenting
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Natsuko |
| Middle name | |
| Last name | Taguchi |
Organization
Chiba University Hospital
Division name
Department of Anesthesiology
Zip code
260-8677
Address
1-8-1 Inohana Chuo Chiba JAPAN
TEL
+81-43-226-2303
nn_taguchi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | KOTONO |
| Middle name | |
| Last name | YAMADA |
Organization
Chiba University Hospital
Division name
Department of Anesthesiology
Zip code
260-8677
Address
1-8-1 Inohana Chuo Chiba JAPAN
TEL
+81-43-226-2303
Homepage URL
kotono1004@yahoo.co.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Chiba University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hospital
Address
1-8-1 Inohana Chuo Chiba JAPAN
Tel
+81-43-226-2303
masui@office.chiba-u.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
HK202305-16
Org. issuing International ID_1
Chiba University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2023 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Fecal samples are collected on the day before or the day of surgery in all eligible patients who have given consent to provide a stool sample. Postoperative pain is scored on an 11-point scale from 0 to 10 using the NRS, with three scores: 24 hours postoperatively, maximum postoperative pain and pain during movement. With a higher NRS group as the high pain group and a lower NRS group as the low pain group, and gut microbiota analysis is performed from preoperative stool samples. The gut microbiota is analysed by rRNA and metabolite analysis.
Management information
Registered date
| 2023 | Year | 08 | Month | 30 | Day |
Last modified on
| 2025 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059413
