This study evaluates the effect of a multistrain probiotic on gastrointestinal (GI) complaints and diarrhoea in subjects receiving short-term antibiotic (AB) treatment
This study aims to investigate the safety and efficacy of live bacteria on gastrointestinal (GI) complaints and diarrhoea in subjects receiving short-term antibiotic (AB) treatment. The trial will be run in Germany and will recruit adult men and women.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
69
Participants in this arm will receive a daily dose of 2x10\^9 Colony Forming Units (CFU) of a multi strain probiotic (live bacterium), corresponding to 2 capsules twice daily, for the duration of antibiotic therapy, and 14 days thereafter.
Participants in this arm will receive an equivalent placebo for for the duration of antibiotic therapy, and 14 day thereafter.
analyze & realize GmbH
Berlin, Weißenseer Weg, Germany
Change in the Gastrointestinal Symptom Rating Score - Irritable Bowel Syndrome (GSRS-IBS)
Change in Gastrointestinal Symptom Rating Score - Irritable Bowel Syndrome total score (max 78) from baseline (V1) to Day 6 - 11 (V2), where higher scores mean worse symptoms
Time frame: Baseline (V1), Day 6 - 11 (V2)
Difference in the Gastrointestinal Symptom Rating Score - Irritable Bowel Syndrome (GSRS-IBS)
Difference in Gastrointestinal Symptom Rating Score - Irritable Bowel Syndrome (GSRS-IBS) total score (max 78) between day 6 - 11 (V2) and day 20 - 25 (V3), where higher scores mean worse symptoms
Time frame: Day 6 - 11 (V2), Day 20 - 25 (V3)
Difference in the Gastrointestinal Symptom Rating Score - Irritable Bowel Syndrome (GSRS-IBS)
Difference in Gastrointestinal Symptom Rating Score - Irritable Bowel Syndrome (GSRS-IBS) total score (max 78) from baseline (V1) to day 20 - 25 (V3) between intervention and placebo, where higher scores mean worse symptoms
Time frame: Baseline (V1), Day 20 - 25 (V3)
Incidence of antibiotic-associated diarrhoea (AAD)
Total incidence rate of antibiotic-associated diarrhoea (AAD) between intervention and placebo, defined as 2 or more days with a stool frequency of 3 or more a day and/or a stool consistency of 5 or more on the Bristol Stool Form Scale (BSFS), throughout the period between baseline (V1) and Day 20 - 25 (V3). The BSFS max score is 7, where lower scores indicate constipation and higher scores indicate diarrhoea
Time frame: Through study completion, an expected average of 21 days
Duration of antibiotic associated diarrhoea (AAD)
Difference in the average continuous days of antibiotic associated diarrhoea (defined as 2 or more days with a stool frequency of 3 or more a day and/or a stool consistency of 5 or more on the Bristol Stool Form Scale (BSFS)) in the intervention and placebo arms between baseline (V1) and day 20 - 25 (V3). The BSFS max score is 7, lower scores indicate constipation and higher scores indicate diarrhoea.
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Time frame: Through study completion, an expected average of 21 days
Difference in individual scores of Gastrointestinal Symptom Rating Score - Irritable Bowel Syndrome (GSRS-IBS)
Difference in average individual Gastrointestinal Symptom Rating Score - Irritable Bowel Syndrome scores (max 7) from Day 6 - 11 (V2) to Day 20 - 25 (V3) where higher scores mean worse symptoms
Time frame: Day 6 - 11 (V2), Day 20 - 25 (V3)
Difference in individual scores of Gastrointestinal Symptom Rating Score - Irritable Bowel Syndrome (GSRS-IBS)
Difference in average individual Gastrointestinal Symptom Rating Score - Irritable Bowel Syndrome (GSRS-IBS) scores (max 7) from Baseline (V1) to Day 6 - 11 (V2), and from Baseline (V1) to Day 20 - 25 (V3) where higher scores mean worse symptoms
Time frame: Baseline (V1), Day 6 - 11 (V2), Day 20 - 25 (V3)
Difference in Stool Consistency
Difference in weekly stool consistency, as measured by the Bristol Stool Form Scale (BSFS) on a daily basis throughout the period between baseline (V1) and Day 20 - 25 (V3). BSFS max score 7 - lower scores indicate constipation, higher scores indicate diarrhea.
Time frame: Through study completion, an expected average of 21 days
Difference in Stool Frequency
Difference in weekly average stool frequency throughout the period between baseline (V1) and day 20 - 25 (V3).
Time frame: Through study completion, an expected average of 21 days
Percentage with diarrhoea
Percentage of participants who have developed diarrhoea (defined as proportion of subjects with stool classified on the Bristol Stool Form Scale (BSFS) as 5-7) throughout the period between baseline (V1) and day 20 - 25 (V3). BSFS max score is 7 - lower scores indicate constipation, higher scores indicate diarrhoea.
Time frame: Through study completion, an expected average of 21 days
Duration of diarrhoea
Duration of diarrhoea (defined as proportion of subjects with Bristol Stool Form Scale (BSFS) of 5-7/day) throughout the period between baseline (V1) and day 20 - 25 (V3). BSFS max score is 7 - lower scores indicate constipation, higher scores indicate diarrhoea.
Time frame: Through study completion, an expected average of 21 days
Metabolomic Analysis of Faecal Samples
Targeted metabolomic analysis of faecal samples using liquid chromatography - mass spectrometry (LC-MS) for differences between baseline (V1), Day 6 - 11 (V2) and Day 20 - 25 (V3) including, but not restricted to succinate
Time frame: Baseline (V1), Day 6 - 11 (V2), Day 20 - 25 (V3)
Difference in Short Form 12 (SF-12) - Mental Component Score
Difference in Short Form-12 (SF-12) mental component score at Day 6 - 11 (V2) and Day 20 - 25 (V3). Higher scores indicate better mental health functioning (max score 100)
Time frame: Day 6 - 11 (V2), Day 20 - 25 (V3)
Difference in Short Form 12 (SF-12) - Physical Component Score
Difference in Short Form-12 (SF-12) physical component score at Day 6 - 11 (V2) and Day 20 - 25 (V3). Higher scores indicate better physical health (max score 100)
Time frame: Day 6 - 11 (V2), Day 20 - 25 (V3)
Difference in Short Form 12 (SF-12) - Mental Component Score (MCS)
Difference in Short Form-12 (SF-12) mental component score (MCS) from baseline (V1) to Day 6 - 11 (V2) and baseline (V1) to Day 20 - 25 (V3). Higher scores indicate better mental health (max score 100)
Time frame: Baseline (V1), Day 6 - 11 (V2), Day 20 - 25 (V3)
Difference in Short Form 12 (SF-12) - Physical Component Score (PCS)
Difference in Short Form-12 (SF-12) physical component score (PCS) from baseline (V1) to Day 6 - 11 (V2) and baseline (V1) to Day 20 - 25 (V3). Higher scores indicate better physical health (max score 100)
Time frame: Baseline (V1), Day 6 - 11 (V2), Day 20 - 25 (V3)