Clinical trial NCT05845073: The Efficacy of a Probiotic for Antibiotic Associated Gastrointestinal Symptoms
Official title: A Pilot Clinical Trial Assessing the Effect of Probiotic Supplementation on Antibiotic Associated Gastrointestinal Symptoms and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antibiotic-associated Diarrhea
Keywords: Probiotic
Antibiotic-associated Diarrhea
GI microbiome
Lactobacillus
Bifidobacterium
Lead sponsor: The Archer-Daniels-Midland Company
Sponsor class: INDUSTRY
Collaborators: name: Analyze & Realize
First posted: 2023-05-06
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Males and females ≥ 18 years and ≤65 years old
2. Body Mass Index 18.5-30 kg/m2
3. Generally in good health
4. 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
5. Having access to a smartphone/tablet or a computer with an internet access, and familiar with the use thereof (checked during the visit)
6. Readiness to keep dietary habits during the study
7. 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
8. Women of childbearing potential:

   * commitment to use contraception methods
   * negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1

Exclusion Criteria:

1. More than 24h from the first dose of AB for diagnosed infections (as per inclusion criterion 4) until screening
2. Intravenously administered antibiotics
3. Taking AB in the last 30 days before starting current AB treatment
4. Taking any probiotic or prebiotic supplements in the last 30 days prior to screening
5. Using antidiarrheal medications / enemas on regular basis
6. Multimedication with microbiome-impacting medications within 30 days before enrolment (e.g. proton pump inhibitors antivirals/immunosuppressants, antidepressants)
7. 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
8. Any form of bowel preparation for endoscopy used in the last 3 months
9. Recent GI surgery (within the last 6 months)
10. Women of child-bearing potential: pregnancy, recently gave birth (within the last 6 months) and/or nursing
11. Recent Covid-19 infection (less than 4 weeks since the first negative SARS-CoV-2 (self) test after the infection)
12. Specific dietary restrictions (e.g. active phase of low Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols (FODMAP) diet)
13. Any dietary mode excluding passage of food via GI tract
14. High intake of alcohol (male subjects \> 14 units per week, female subjects, \>11 (1 unit corresponds to 360 mL beer, 45 mL spirits (40% alcohol) or 150 mL wine)
15. History of confirmed Clostridium difficile infection in the last 6 months
16. Known allergy or hypersensitivity to any ingredients of the IP
17. Previous adverse reactions to antibiotics
18. Artificial or damaged heart valves
19. History and/or presence of other clinically significant known (self-reported) condition/ disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject, e.g.:

    * acute pancreatitis
    * immunodeficiency
    * eating disorder
    * recurrent diarrhoea
20. History of or current abuse of drugs or medication
21. Inability to comply with study requirements
22. Subjects who are deprived of their freedom by administrative or legal decision or who are in guardianship
23. Participation in another clinical study in the 30 days prior to V1 and during the study

Primary outcomes:
measure: Change in the Gastrointestinal Symptom Rating Score - Irritable Bowel Syndrome (GSRS-IBS)
timeFrame: Baseline (V1), Day 6 - 11 (V2)
Secondary outcomes:
measure: Difference in the Gastrointestinal Symptom Rating Score - Irritable Bowel Syndrome (GSRS-IBS)
timeFrame: Day 6 - 11 (V2), Day 20 - 25 (V3)
measure: Difference in the Gastrointestinal Symptom Rating Score - Irritable Bowel Syndrome (GSRS-IBS)
timeFrame: Baseline (V1), Day 20 - 25 (V3)
measure: Incidence of antibiotic-associated diarrhoea (AAD)
timeFrame: Through study completion, an expected average of 21 days
measure: Duration of antibiotic associated diarrhoea (AAD)
timeFrame: Through study completion, an expected average of 21 days
measure: Difference in individual scores of Gastrointestinal Symptom Rating Score - Irritable Bowel Syndrome (GSRS-IBS)
timeFrame: Day 6 - 11 (V2), Day 20 - 25 (V3)
measure: Difference in individual scores of Gastrointestinal Symptom Rating Score - Irritable Bowel Syndrome (GSRS-IBS)
timeFrame: Baseline (V1), Day 6 - 11 (V2), Day 20 - 25 (V3)
measure: Difference in Stool Consistency
timeFrame: Through study completion, an expected average of 21 days
measure: Difference in Stool Frequency
timeFrame: Through study completion, an expected average of 21 days
measure: Percentage with diarrhoea
timeFrame: Through study completion, an expected average of 21 days
measure: Duration of diarrhoea
timeFrame: Through study completion, an expected average of 21 days
measure: Metabolomic Analysis of Faecal Samples
timeFrame: Baseline (V1), Day 6 - 11 (V2), Day 20 - 25 (V3)
measure: Difference in Short Form 12 (SF-12) - Mental Component Score
timeFrame: Day 6 - 11 (V2), Day 20 - 25 (V3)
measure: Difference in Short Form 12 (SF-12) - Physical Component Score
timeFrame: Day 6 - 11 (V2), Day 20 - 25 (V3)
measure: Difference in Short Form 12 (SF-12) - Mental Component Score (MCS)
timeFrame: Baseline (V1), Day 6 - 11 (V2), Day 20 - 25 (V3)
measure: Difference in Short Form 12 (SF-12) - Physical Component Score (PCS)
timeFrame: Baseline (V1), Day 6 - 11 (V2), Day 20 - 25 (V3)
Other outcomes:
measure: Evaluation of Study Benefit
timeFrame: Day 20 - 25 (V3)
measure: Matching records between blinded self-assessment
timeFrame: Day 20 - 25 (V3)
measure: Stool Microbiome Assessment
timeFrame: Baseline (V1), Day 6 - 11 (V2), Day 20 - 25 (V3)
measure: Change in body weight
timeFrame: Baseline (V1), Day 20 - 25 (V3)
Locations:
city: Berlin
country: Germany
facility: analyze & realize GmbH
state: Weißenseer Weg
Study officials:
References: