UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046832 |
|---|---|
| Receipt number | R000053183 |
| Scientific Title | Prediction accuracy of algorism for entric microbiota scoring to discriminate constipation or diarrhea symptoms in healthy subjects and patients with constipation, diarrhea, or mixed-type irritable bowel syndrome (PALETTE-IBS study) |
| Date of disclosure of the study information | 2022/02/10 |
| Last modified on | 2024/02/05 12:03:02 |
* 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
Prediction accuracy of algorism for entric microbiota scoring to discriminate constipation or diarrhea symptoms in healthy subjects and patients with constipation, diarrhea, or mixed-type irritable bowel syndrome (PALETTE-IBS study)
Acronym
Prediction accuracy of algorism for entric microbiota scoring to discriminate constipation or diarrhea symptoms in healthy subjects and patients with constipation, diarrhea, or mixed-type irritable bowel syndrome (PALETTE-IBS study)
Scientific Title
Prediction accuracy of algorism for entric microbiota scoring to discriminate constipation or diarrhea symptoms in healthy subjects and patients with constipation, diarrhea, or mixed-type irritable bowel syndrome (PALETTE-IBS study)
Scientific Title:Acronym
Prediction accuracy of algorism for entric microbiota scoring to discriminate constipation or diarrhea symptoms in healthy subjects and patients with constipation, diarrhea, or mixed-type irritable bowel syndrome (PALETTE-IBS study)
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the accuracy of discriminating diarrhea or constipation symptoms of diarrhea-type and constipation-type scores calculated using data on gut microbiota
Basic objectives2
Others
Basic objectives -Others
Discrimination accuracy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area under the ROC curve to discriminate diarrhea or constipation symptoms by diarrhea-type and constipation-type scores
Key secondary outcomes
1. Sensitivity and specificity for discrimination of diarrhea or constipation symptoms by diarrhea-type and constipation-type scores at cutoff value
2. Optimal cutoff values for discrimination of diarrhea or constipation symptoms by diarrhea-type and constipation-type scores
3. gut microbial metagenome in healthy subjects and patients with diarrhea-type, constipation-type, and mixed-type IBS
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. male and female who are aged of 20 years or older and younger than 60 years at giving their consent
2. healthy individuals (those who are not regularly visiting hospitals or taking prescription drugs on a regular basis at giving their consent)
3. subjects whose first language is Japanese.
4. subjects who give their consent to participate in this study by written form
Key exclusion criteria
1. subjects who have taken antibiotics or antibacterial drugs within the last 3 months before giving their consent
2. subjects who have taken antidepressants, antipsychotics, or anxiolytics on a daily basis within the last 3 months before giving their consent (except medication when needed)
3. subjects who have IBS symptoms based on Rome IV criteria, or have a history of IBS
4. subjects with chronic constipation or diarrhea
5. subjects with digestive disorders such as inflammatory bowel disease
6. subjects with history of major digestive system surgery such as gastrectomy, gastrointestinal suture, intestinal resection, etc.
7. subjects with a history of cancer of the digestive system.
8. subjects who are pregnant, breastfeeding, possibly pregnant, or planning to become pregnant
9. subjects who need a regal representative
10. subjects who are judged by the responsible investigator or sub-investigator to be inappropriate for participation in the study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Torii |
Organization
Torii Naika Clinic
Division name
Internal Medicine, Gastroenterology, Allergy
Zip code
157-0066
Address
Seijo corty 3F, Seijo 6-5-34, Setagaya, Tokyo, Japan
TEL
03-3482-3737
akiratorii23@gmail.com
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Takayama |
Organization
Soiken, Inc.
Division name
Clinical Study Support Division
Zip code
101-0052
Address
NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo, Japan
TEL
03-3295-1350
Homepage URL
takayama@soiken.com
Sponsor or person
Institute
Japan Physicians Association
Institute
Department
Personal name
Funding Source
Organization
Kirin Holdings Company, Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Physicians Association Institutional Review Board
Address
Tokyo Medical Association Building 4F, 2-5, Kanda-Surugadai, Chiyoda, Tokyo, Japan
Tel
03-3259-6177
irb@nichirinnai.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
鳥居内科クリニック
ちほ内科クリニック
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 10 | Day |
Related information
URL releasing protocol
unpublished
Publication of results
Unpublished
Result
URL related to results and publications
unpublished
Number of participants that the trial has enrolled
40
Results
This study evaluated the accuracy of diarrhea-type and constipation-type scores calculated using data on gut microbiota. As results, AUC between patients with IBS who having diarrhea symptoms and healthy subjects was 0.599, and AUC between patients with IBS who having constipation symptoms and healthy subjects was 0.645, both of which were lower than the hypotheses (AUC > 0.7). It seemed to be difficult to utilize these indexes to discriminate subjects with diarrhea or constipation symptoms.
Results date posted
| 2024 | Year | 02 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
[Age (year (SD))] 36.5 (11.2)
[Sex (Male (%) / Female (%))] 22 (55.0) / 18 (45.0)
[BMI (kg/m2 (SD))] 22.0 (2.6)
Participant flow
2022/1/6 Protocol approved by institutional review board
2022/3/10 First subject in
2022/4/15 Last subject in
2022/5/16 Last subject last visit
Adverse events
none
Outcome measures
This study evaluated the the accuracy of discriminating diarrhea or constipation symptoms of diarrhea-type and constipation-type scores calculated using data on gut microbiota, under the hypotheses that diarrhea-type score had discriminating accuracy of patients with IBS who having diarrhea symptoms and healthy subjects with AUC or higher than 0.7 and that constipation-type score had discriminating accuracy of patients with IBS who having constipation symptoms and healthy subjects with AUC or higher than 0.7. As results, AUC between patients with IBS who having diarrhea symptoms and healthy subjects was 0.599 (95% confidence interval of 0.473-0.726), and AUC between patients with IBS who having constipation symptoms and healthy subjects was 0.645 (95% confidence interval of 0.520-0.769), both of which were lower than the hypotheses. Because AUC of all combinations were approximately 0.6 in both diarrhea-type and constipation-type scores, it seemed to be difficult to utilize these indexes to discriminate subjects who having diarrhea or constipation symptoms.
Plan to share IPD
none
IPD sharing Plan description
none
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 16 | Day |
Date of closure to data entry
| 2022 | Year | 05 | Month | 16 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 23 | Day |
Date analysis concluded
| 2023 | Year | 05 | Month | 11 | Day |
Other
Other related information
The healthy volunteers will be newly recruited, and the gut microbiota gene data obtained by metagenomic analysis from the collected fecal samples will be used in this study as the control group data.
For the case group data, the gut microbiota gene data at observation point 0 (-8 weeks) from a previous study, "Trial for application of individualized oral prebiotics and probiotics supplements on the subjective severity in patients with irritable bowel syndrome; multicenter, open-label non-randomized, single-arm trial" (TAILOR-IBS study / jRCTs031210343) will be used.
The accuracy of discriminating diarrhea or constipation symptoms by diarrhea-type or constipation-type scores calculated using the gut microbiota assessment algorithm will be verified.
Management information
Registered date
| 2022 | Year | 02 | Month | 04 | Day |
Last modified on
| 2024 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053183
