A Pilot Clinical Trial Assessing the Effect of Probiotic Supplementation on Antibiotic Associated Gastrointestinal Symptoms and Quality of Life

The Archer-Daniels-Midland Company1 site in 1 country69 target enrollmentMay 9, 2023

ConditionsAntibiotic-associated Diarrhea

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Antibiotic-associated Diarrhea
Sponsor: The Archer-Daniels-Midland Company
Enrollment: 69
Locations: 1
Primary Endpoint: Change in the Gastrointestinal Symptom Rating Score - Irritable Bowel Syndrome (GSRS-IBS)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study evaluates the effect of a multistrain probiotic on gastrointestinal (GI) complaints and diarrhoea in subjects receiving short-term antibiotic (AB) treatment

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

May 9, 2023

End Date

July 25, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The Archer-Daniels-Midland Company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males and females ≥ 18 years and ≤65 years old
•Body Mass Index 18.5-30 kg/m2
•Generally in good health
•Use of broad spectrum orally administered AB(s) for no more than 24h prior to V1 (penicillins, cephalosporins, quinolones, tetracyclines and lincomycins) for diagnosed infections other than those of GI, urinary or reproductive tract not requiring hospitalization, with a foreseen total duration of AB intake of 5-7 days
•Having access to a smartphone/tablet or a computer with an internet access, and familiar with the use thereof (checked during the visit)
•Readiness to keep dietary habits during the study
•Readiness to avoid the use of any nutritional (e. g. prebiotic, probiotic), medical and further interventional options for management of GI complaints/diarrhoea (beyond the IP) during the study
•Women of childbearing potential:
•commitment to use contraception methods
•negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1

Exclusion Criteria

•More than 24h from the first dose of AB for diagnosed infections (as per inclusion criterion 4) until screening
•Intravenously administered antibiotics
•Taking AB in the last 30 days before starting current AB treatment
•Taking any probiotic or prebiotic supplements in the last 30 days prior to screening
•Using antidiarrheal medications / enemas on regular basis
•Multimedication with microbiome-impacting medications within 30 days before enrolment (e.g. proton pump inhibitors antivirals/immunosuppressants, antidepressants)
•Clinically relevant (as per investigator judgement) self-reported chronic diseases of GI tract (e.g. inflammatory bowel syndrome, Crohn's disease, ulcerative colitis, celiac disease, diverticulitis, idiopathic esophageal reflux, malabsorption disorder, severe constipation), urinary tract, reproductive tract (e.g. endometriosis, adenomyosis, pelvic inflammatory disease, uterine fibroids) or metabolic (diabetes (type 1 or Type 2), familial hypercholestraemia, hereditary haemachromatosis) diseases
•Any form of bowel preparation for endoscopy used in the last 3 months
•Recent GI surgery (within the last 6 months)
•Women of child-bearing potential: pregnancy, recently gave birth (within the last 6 months) and/or nursing

Outcomes

Primary Outcomes

Change in the Gastrointestinal Symptom Rating Score - Irritable Bowel Syndrome (GSRS-IBS)

Time Frame: Baseline (V1), Day 6 - 11 (V2)

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

Secondary Outcomes

Metabolomic Analysis of Faecal Samples(Baseline (V1), Day 6 - 11 (V2), Day 20 - 25 (V3))
Difference in the Gastrointestinal Symptom Rating Score - Irritable Bowel Syndrome (GSRS-IBS)(Baseline (V1), Day 20 - 25 (V3))
Incidence of antibiotic-associated diarrhoea (AAD)(Through study completion, an expected average of 21 days)
Duration of antibiotic associated diarrhoea (AAD)(Through study completion, an expected average of 21 days)
Difference in Stool Consistency(Through study completion, an expected average of 21 days)
Difference in Short Form 12 (SF-12) - Mental Component Score(Day 6 - 11 (V2), Day 20 - 25 (V3))
Difference in Short Form 12 (SF-12) - Physical Component Score(Day 6 - 11 (V2), Day 20 - 25 (V3))
Difference in Short Form 12 (SF-12) - Mental Component Score (MCS)(Baseline (V1), Day 6 - 11 (V2), Day 20 - 25 (V3))
Duration of diarrhoea(Through study completion, an expected average of 21 days)
Difference in individual scores of Gastrointestinal Symptom Rating Score - Irritable Bowel Syndrome (GSRS-IBS)(Baseline (V1), Day 6 - 11 (V2), Day 20 - 25 (V3))
Difference in Stool Frequency(Through study completion, an expected average of 21 days)
Percentage with diarrhoea(Through study completion, an expected average of 21 days)
Difference in Short Form 12 (SF-12) - Physical Component Score (PCS)(Baseline (V1), Day 6 - 11 (V2), Day 20 - 25 (V3))