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

JRCT ID: jRCTs021210038

Registered date:24/09/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Irritable Bowel Syndrome
• Date of first enrollment: 04/04/2022
• Target sample size: 70
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Change in severity of IBS symptoms at week 12 from baseline

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Fukudo Shin
• Source(s) of Monetary Support: Biofermin Pharmaceutical Co., Ltd.