The Effects of Bifidobacterium Breve Bif195 for Small Intestinal Crohn's Disease

Hvidovre University Hospital

Status: Active, not recruiting

Conditions: Crohn Disease

Treatments: Dietary Supplement: Placebo capsules; Dietary Supplement: Bif195 capsules

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04842149

H-20068527

Details and patient eligibility

About

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 small intestinal Crohn's disease.

Full description

Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) with an incidence rate at 11/100 000 per year in Denmark.

The disease can potentially affect the entire gastrointestinal tract, though the most common affected area is terminal ileum and the adjacent part of colon.

CD is a result of both genetic and environmental factors together with the intestinal microbiota, however the precise etiology is unclear.

A change of the intestinal microbiota with a reduced occurrence of e.g. Bacteroides species, Firmicutes and the anti-inflammatory bacteria Faecalibacterium prausnitzii is found in CD patients compared to healthy controls. Also a reduction of the mucosa-associated Bifidobacteria has been associated with the risk of mucosal inflammation.

The hypothesis that an imbalance between potentially beneficial and pathogenic bacteria contribute to the pathogenesis of IBD, including CD, has led to the suggestion that manipulation of the microbiota may be an attractive target for therapeutic interventions in IBD.

A new probiotic bacterium, Bifidobacterium breve Bif195 (Bif195) has been identified and has shown great effects on preventing enteropathy and ulcers on the gut mucosa in healthy volunteers given acetylsalicylic acid (13), and thereby Bif195 has also shown a potential in reducing gut permeability defects. This bacterium has not yet been investigated in CD patients.

Enrollment: 33 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with small intestinal CD
• Fecal calprotectin ≥ 250 ug/g
• IUS evidence of small bowel inflammation with wall thickness ≥ 4 mm
• At least 3 months af stable medical treatment
• Able to read and speak Danish

Exclusion criteria

• Positive rectal swab for pathogenic microorganisms
• Use of antibiotics, probiotics and systemic glucocorticosteroids within 4 weeks prior to inclusion
• Participation in other clinical trials within 30 days prior to inclusion
• Pregnancy, planned pregnancy or breast feeding
• Psychiatric disease
• Abuse of alcohol or drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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33 participants in 2 patient groups, including a placebo group

Bif195 capsules

Active Comparator group

Description:

The capsule will contain approximately 15\*10\^9 CFU of Bif195 per day. Excipients: Microcrystalline Cellulose 6 mg per capsule, Magnesium Stearate 1.5 mg per capsule, Maltodextrin 277.8 mg per capsule, and Sodium Ascorbate 14.7 mg per capsule.

Treatment:

Dietary Supplement: Bif195 capsules

Placebo capsules

Placebo Comparator group

Description:

The capsule contain only excipients: Microcrystalline Cellulose 6 mg per capsule, Magnesium Stearate 1.5 mg per capsule, Maltodextrin 277.8 mg per capsule, and Sodium Ascorbate 14.7 mg per capsule.

Treatment:

Dietary Supplement: Placebo capsules