臨床研究等提出・公開システム

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)

TAILOR-IBS study

120

[Age (year (SD))] 40.3 (11.5) [sex (n (%))] male 27 (23.3) / female 89 (76.7) [BMI (kg/m2 (SD))] 21.3 (3.7) [Duration of IBS (year (SD))] 6.5 (9.0)

2021/8/28 Protocol approved by certified review board 2021/9/24 First publication in jRCT 2021/10/11 First subject in 2022/12/29 Last subject in 2023/4/22 Last subject last visit 2023/8/4 Database lock 2023/9/28 Development of Statistical Analysis Report

Death (n (%))] 0 (0.0) [Adverse event (n (%))] 32 (27.6) [Serious adverse event (n (%))] 1 (0.9) [Disease-or-the-like (n (%))] 10 (8.6) [Serious disease-or-the-like (n (%))] 0 (0.0)

- Supplementation of individualized prebiotics and probiotics significantly improved psychological attitude (subjective severity) in patients with diarrhea-type and constipation-type IBS. - Bowel frequency was improved in patients with constipation-type IBS by the supplementation of the individualized prebiotics and probiotics. - The efficacy of the supplementation of the individualized prebiotics and probiotics in patients with mixed-type IBS was difficult to be asessed due to the disease condition in which diarrhea and constipation alternatively appeared. - No specific adverse event or safety concern were observed by the supplementation of the individualized prebiotics and probiotics.

This study demonstrated that supplementation of individualized prebiotics and probiotics significantly improved psychological attitude (subjective severity) in patients with diarrhea-type and constipation-type IBS. Especially, it seemed to be meaningful that bowel frequency was improved in patients with constipation-type IBS. From these results, the supplementation of the individualized prebiotics and probiotics might be an effective tool for self-medication for IBS without medical agent.

Feb. 01, 2025

No

none

https://jrct.mhlw.go.jp/latest-detail/jRCTs031210343

Torii Akira

Torii Naika Clinic

Seijo corty 3F, Seijo 6-5-34, Setagaya, Tokyo, Japan

akiratorii23@gmail.com

Torii Akira

Torii Naika Clinic

Seijo corty 3F, Seijo 6-5-34, Setagaya, Tokyo, Japan

+81-3-3482-3737

akiratorii23@gmail.com

Complete

Sept. 24, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Patients who meet all of the following criteria are included in this study;
1. Patients who are diagnosed with diarrhea-predominant irritable bowel syndrome (IBS-D), constipation-predominant irritable bowel syndrome (IBS-C), or mixed-form irritable bowel syndrome (IBS-M) based on Rome IV diagnostic criteria.
2. Male and female aged 20 years or older, and younger than 60 years.
3. Subjects whose native language is Japanese.
4. Subjects who provide their written consent form to participate in the study.

Patients who meet any of the following criteria are excluded from the study;
1. Patients who took antibiotics or antimicrobial agents within the last 3 months before giving their consent.
2. Patients who are diagnosed with gastrointestinal disorders such as inflammatory bowel disease.
3. Patients with hisotory of major gastrointestinal surgery such as gastrectomy, gastrointestinal suture, or intestinal resection.
4. Patients who have taken antidepressants, antipsychotics, or anxiolytics on a daily basis within the last 3 months before giving their consent (excluding those who take the drugs as needed)
5. Patients who take drugs that suppress immune function at giving their consent.
6. Patients who take drugs that affect blood glucose or blood pressure at giving their consent.
7. Patients with history of allergy against the active ingredients* of the study foods
*active ingredients: arabinogalactan, Guar Gum degradant, pectin, delipidated rice bran, inulin, cornstarch, psyllium, bifidobacteria, lactobacillus
8. Patients who have a history of cancer in the gastrointestinal organs or who are currently receiving treatment or medications for cancer in the gastrointestinal organs.
9. Patients with serious cerebrovascular disease, cardiac disease, hepatic disease, renal disease, gastrointestinal disease, or infectious disease requiring notification
10. Patients who are pregnant, breastfeeding, possibly pregnant, or planning to be pregnant.
11. Patients who need legal representative for giving their consent.
12. Patients who are considered to be unsuitable for participating in this study by investigators.

Both

Irritable Bowel Syndrome

After obtaining consent to participate in this study, gut microbiota is measured at visit 0 (week -8).
Individualized study foods are determined from 5 types of prebiotics and 2 types of probiotics, based on the each study subject's IBS symptoms and the condition of gut microbiota.
The study subjects intake the provided individualized study foods twice daily after the tests of visit 1 (week 0/baseline) till visit 2 (week 4 +/- 1 week), in principle, before breakfast and dinner.

probiotics, prebiotics

D043183

D019936, D056692

Change in total score of IBS-severity scoring system (IBS-SSS) from baseline to week 4

1. Change in each item score of IBS-SSS (abdominal pain, bloating/distension, satisfaction with bowel habits, and IBS-related quality of life (QoL)) from baseline to week 4.
2. Change in total score of IBS-QOL from baseline to week 4.
3. Change in defecation frequency and fecal condition from baseline to week 4.
4. Change in enteric bacteria genes from baseline to week 4.
5. Change in diarrhea score and constipation score from baseline to week 4.

+81-3-5763-6034

Aug. 28, 2021

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