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

Not Applicable

Recruiting

• Conditions: Irritable Bowel Syndrome; Chronic Diseases, Functional; C06.405.469.158.272.608

• Registration Number: JPRN-jRCTs021210038
• Lead Sponsor: Fukudo Shin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-24
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in severity of IBS symptoms at week 12 from baseline

Secondary Outcome Measures

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