Efficacy of Bifidobacterium Agent on Patients with Irritable Bowel Syndrome: A Randomized Controlled Trial

Efficacy of Bifidobacterium Agent on Patients with Irritable Bowel Syndrome: A Randomized Controlled Trial - IBS-Bb-RCT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs021210038

Enrollment

Registered

2021-09-24

Start date

2022-04-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome Chronic Diseases, Functional

Interventions

A: Placebo 6 tablets per day for 12 weeks B: Bifidobacterium bifidum 6 tablets per day for 12 weeks

Probiotics

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subjects with IBS diagnosed with Rome IV criter ia 2. Subjects who want to receive IBS treatment of t he first step in clinical practice guideline of JSGE 2 020 3. Aged 18-75 years at the time of informed conse nt 4. Provision of written informed consent

Exclusion criteria

Exclusion criteria: 1. Major abdominal surgery (except appendectomy or hysterectomy) 2. History of inflammatory bowel disease, ischemic colitis, malignant tumor 3. Severe neurological complications (Parkinson's disease, Shy-Drager syndrome, schizophrenia, bip olar disorder) 4. Use of probiotics within 4 weeks prior to randomization 5. Allergy to probiotics 6. Allergy to starch 7. Severe complications (hepatic diseases, serious cardiovascular diseases, hematological diseases, metabolic diseases or malignant neoplasms) 8. Pregnancy, breastfeeding or planning on becom ing pregnant throughout the course of the study 9. Unable to take MRI 10. Severe disturbance in lifestyle 11. No existence of abdominal pain or no bowel dysfunction 12. Gdaduate school students in the department of the principal investigator 13. Lack of suitability for participation in the study for any reason as judged by the investigator

Design outcomes

Primary

Measure	Time frame
Change in severity of IBS symptoms at week 12 from baseline	—

Secondary

Measure	Time frame
1. Subscales of IBS-SI 2. STAI State-Trait Anxiety Inventory scores 3. SDS Self-rating Depression Scale score 4. IBS-QOL score 5. Daily number of stools 6. Stool consistency 7. Abdominal pain severity, abdominal fullness an d anxiety scores 8. Improvement rates of abdominal pain severity, abdominal fullness and anxiety scores	—

Contacts

Public ContactMotoyori Kanazawa

Tohoku University Hospital

m-kanazawa@med.tohoku.ac.jp+81-22-717-8162

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026