jRCTs031210343CompletedNot Applicable
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)
Not provided0 sites120 target enrollmentStarted: October 11, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 120
- Primary Endpoint
- -
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Single Arm Study
- Intervention Model
- Single Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Open(masking Not Used)
Eligibility Criteria
- Ages
- 20age old over to 60age old not (—)
- Sex
- All
Inclusion Criteria
- •Patients who meet all of the following criteria are included in this study;
- •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.
- •Male and female aged 20 years or older, and younger than 60 years.
- •Subjects whose native language is Japanese.
- •Subjects who provide their written consent form to participate in the study.
Exclusion Criteria
- •Patients who meet any of the following criteria are excluded from the study;
- •Patients who took antibiotics or antimicrobial agents within the last 3 months before giving their consent.
- •Patients who are diagnosed with gastrointestinal disorders such as inflammatory bowel disease.
- •Patients with hisotory of major gastrointestinal surgery such as gastrectomy, gastrointestinal suture, or intestinal resection.
- •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)
- •Patients who take drugs that suppress immune function at giving their consent.
- •Patients who take drugs that affect blood glucose or blood pressure at giving their consent.
- •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
- •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.
- •Patients with serious cerebrovascular disease, cardiac disease, hepatic disease, renal disease, gastrointestinal disease, or infectious disease requiring notification
- •Patients who are pregnant, breastfeeding, possibly pregnant, or planning to be pregnant.
- •Patients who need legal representative for giving their consent.
- •Patients who are considered to be unsuitable for participating in this study by investigators.
Outcomes
Primary Outcomes
-
Change in total score of IBS-severity scoring system (IBS-SSS) from baseline to week 4
Secondary Outcomes
- Change in each item score of IBS-SSS(from baseline to week 4)
Investigators
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