TAILOR-IBS study

JRCT ID: jRCTs031210343

Registered date:24/09/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Irritable Bowel Syndrome
• Date of first enrollment: 24/09/2021
• Target sample size: 120
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

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

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 60age old
• Gender: Both

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Torii Akira
• Secondary Sponsor: Kirin Holdings Company, Limited