A randomized controlled trial to investigate the efficacy of a multispecies probiotic supplement (Ecologic® BARRIER) on symptoms of fatigue in subjects with Inflammatory Bowel Disease

A randomized controlled trial to investigate the efficacy of a multispecies probiotic supplement (Ecologic® BARRIER) on symptoms of fatigue in subjects with Inflammatory Bowel Disease - Probiotics against fatigue in IBD

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55158

Enrollment

220

Registered

2019-10-28

Start date

2020-01-07

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic bowel inflammation inflammatory bowel disease

Interventions

Group A will daily receive 4 grams (2,5*109 cfu/gram) of the probiotic supplement Ecologic® BARRIER for the period of 12 weeks. Group B will be randomized to receive 4 grams of the placebo, identica

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Subjects between the ages of 18 and 75 years old. • Subjects diagnosed with Crohn*s disease or Ulcerative Colitis. • Subjects with a score of 4 or higher on the Chalder Fatigue Questionnaire.

Exclusion criteria

Exclusion criteria: - active inflammation - abnormal labvalus - use of prohbited medication - stoma or pouch

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this study is the difference in fatigue as measured by the Chalder Fatigue Questionnaire (CFQ) between the probiotics and placebo group.	—

Secondary

Measure	Time frame
The secondary endpoints of the study are the differences in QoL indicated by the Inflammatory Bowel Disease Questionnaire (IBDQ) and the EuroQoL 5D questionnaire (EQ-5D), sleep quality examined by the Pittsburgh Sleep Quality Index (PSQI), stool frequency and - consistency measured by the Bristol Stool Scale (BSS) and standard clinical laboratory assessments.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)