The Efficacy of a Probiotic for Antibiotic Associated Gastrointestinal Symptoms

NCT ID: NCT05845073

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-09
• Study Completion Date: 2024-07-25

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.

Conditions

Antibiotic-associated Diarrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Probiotic

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.

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

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.

Placebo

Participants in this arm will receive an equivalent placebo for the duration of antibiotic therapy, and 14 day thereafter.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Participants in this arm will receive an equivalent placebo for for the duration of antibiotic therapy, and 14 day thereafter.

Interventions

Probiotic

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Participants in this arm will receive an equivalent placebo for for the duration of antibiotic therapy, and 14 day thereafter.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Analyze & Realize

NETWORK

Sponsor Role: collaborator

The Archer-Daniels-Midland Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

analyze & realize GmbH

Berlin, Weißenseer Weg, Germany

Countries

Germany

Other Identifiers

CTB2022N104

Identifier Type: -

Identifier Source: org_study_id