NCT04842149

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 13, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

May 21, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

May 30, 2025

Status Verified

October 1, 2023

Enrollment Period

2.9 years

First QC Date

April 8, 2021

Last Update Submit

May 26, 2025

Conditions

Crohn Disease

Keywords

Probiotics

Outcome Measures

Primary Outcomes (1)

  • Change in Bowel Wall Thickness (BWT) from baseline measured by intestinal ultrasound (IUS) at 8 weeks

    IUS will be performed in the non-fasting patient lying in supine position with a high-end ultrasound machine (Siemens Sequoia) with 10L4 transducer.

    8 weeks

Secondary Outcomes (5)

  • Change in fecal calprotectin level from baseline at 8 weeks

    8 weeks

  • Change in severity of symptoms from baseline measured by Harvey-Bradshaw index (HBI) at 8 weeks

    8 weeks

  • Change in quality of life from baseline measured by Inflammatory Bowel Disease Questionnaire (IBDQ) Questionnaire Scores at 8 weeks

    8 weeks

  • The change from baseline on Color Doppler Imaging Score (0-3) including inflammatory fat and ulceration (yes/no) at 8 weeks

    8 weeks

  • Adverse and severe adverse events

    16 weeks

Study Arms (2)

Bif195 capsules

ACTIVE COMPARATOR

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.

Dietary Supplement: Bif195 capsules

Placebo capsules

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo capsules

Interventions

Bif195 capsulesDIETARY_SUPPLEMENT

1 capsule daily for 8 weeks

Bif195 capsules
Placebo capsulesDIETARY_SUPPLEMENT

1 capsule daily for 8 weeks

Placebo capsules

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Positive rectal swab for pathogenic microorganisms
  • Pregnancy, planned pregnancy or breast feeding
  • Psychiatric disease
  • Abuse of alcohol or drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastrounit, Copenhagen University Hospital Hvidovre

Hvidovre, Copenhagen, 2650, Denmark

Location

Related Publications (1)

  • Gronbaek IMB, Halkjaer SI, Mollerup S, Hansen EH, Paulsen SJ, Engel S, Theede K, Wilkens R, Boysen T, Petersen AM. The effects of probiotic treatment with Bifidobacterium breve, Bif195 for small intestinal Crohn's disease and the gut microbiome: results from a randomised, double-blind, placebo-controlled trial. Gut Pathog. 2025 Apr 9;17(1):19. doi: 10.1186/s13099-025-00692-6.

    PMID: 40205497DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Andreas M Petersen, MD, PhD

    Gastrounit, Copenhagen University Hospital Hvidovre, Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MD, PhD

Study Record Dates

First Submitted

April 8, 2021

First Posted

April 13, 2021

Study Start

May 21, 2021

Primary Completion

April 30, 2024

Study Completion

November 30, 2024

Last Updated

May 30, 2025

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)