Irritable Bowel Syndrome Clinical Trial
Official title:
The Effects of Bifidobacterium Breve Bif195 for Diarrhea-predominant Irritable Bowel Syndrome: a Double-blind, Randomized, Placebo-controlled Study
NCT number | NCT04808271 |
Other study ID # | H-20060730 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 16, 2021 |
Est. completion date | May 9, 2023 |
Verified date | July 2023 |
Source | Hvidovre University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to investigate if the probiotic Bifidobacterium breve Bif195 (Bif195) will result in improvement in clinical outcome in patients with diarrhea-predominant irritable bowel syndrome (IBS).
Status | Completed |
Enrollment | 61 |
Est. completion date | May 9, 2023 |
Est. primary completion date | May 9, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Diagnosed with IBS-D defined as more than one-fourth (25%) of bowel movements with Bristol Stool Scale Types 6-7 and less than one-fourth (25%) with Types 1-2 - Fulfill Rome IV diagnostic criteria for IBS - Moderate to severe disease activity (IBS-SSS =175) - Able to read and speak Danish - Normal colonoscopy (performed within 1 year) if the patient had blood in stool Exclusion Criteria: - Other chronic gastro intestinal diseases including lactose intolerance and coeliac disease - Fecal calprotectin =50 mg/kg - Fecal sample positive for enteropathogenic microorganisms - Surgical interventions in the GI region (except for appendectomy, hernia repair, cholecystectomy and gynecological and urological procedures) - Psychiatric disorder - Abuse of alcohol or drugs - Medications except birth control pills, hormone supplements, allergies/asthma agents, blood pressure and cholesterol-lowering agents, proton pump inhibitors and non-prescription medicines; abnormal colonoscopy findings - Pregnancy, planned pregnancy or breastfeeding females - Ingestion of probiotics or antibiotics <4 weeks before the inclusion - Abnormal screening biochemistry |
Country | Name | City | State |
---|---|---|---|
Denmark | Copenhagen University Hospital Hvidovre | Hvidovre | |
Denmark | Hvidovre Hospital, Copenhagen University | Hvidovre | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Hvidovre University Hospital | Chr Hansen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in IBS symptoms from baseline measured by IBS-severity scoring system (IBS-SSS) at 8 weeks | IBS-SSS is a composite score of abdominal pain, number of days with abdominal pain, bloating/distension, satisfaction with bowel habits, and IBS-related quality of life. Each measure is rated from 0 to 100, with total scores ranging from 0 (best) to 500 (worst). | 8 weeks | |
Secondary | Change in quality of life from baseline measured by Irritable Bowel Syndrome-Quality of Life (IBS-QOL) Questionnaire Scores at 8 weeks | The IBS-QoL questionnaire consists of 34 items, each with a 5-point response scale. The 34 items are based on the following eight variables: health worries, food avoidance, body image, dysphoria, interference with activity, social reactions, sexual activity and relationships. The IBS-QoL score will be transformed into a 0-100 scale using the formula: total score = (sum of the items-34/170) ×100. Low score (best) | 8 weeks | |
Secondary | Changes from baseline in bowel habits at 8 weeks | measured by frequency/day and Bristol Stool Form Scale. The Bristol Stool Form Scale is divided into seven categories were a low value indicate constipation and a high value indicate diarrhoea. | 8 weeks | |
Secondary | Change from baseline in abdominal pain at 8 weeks | Measured by a VAS scale from 0-10. 0 = no pain, 10 = worst pain | 8 weeks | |
Secondary | Adverse events | Reported according to IHC-GCP | 16 weeks |
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