The Efficacy of a Probiotic for Antibiotic Associated Gastrointestinal Symptoms

NCT05845073 | Completed

• 1 other identifier: CTB2022N104
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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

Conditions

Antibiotic-associated Diarrhea

Keywords

Probiotic; Antibiotic-associated Diarrhea; GI microbiome; Lactobacillus; Bifidobacterium

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline (V1), Day 6 - 11 (V2)

Secondary Outcomes (15)

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

  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 individual scores of Gastrointestinal Symptom Rating Score - Irritable Bowel Syndrome (GSRS-IBS)

  Day 6 - 11 (V2), Day 20 - 25 (V3)

Other Outcomes (4)

• Evaluation of Study Benefit

  Day 20 - 25 (V3)

• Matching records between blinded self-assessment

  Day 20 - 25 (V3)

• Stool Microbiome Assessment

  Baseline (V1), Day 6 - 11 (V2), Day 20 - 25 (V3)

Study Arms (2)

Probiotic

EXPERIMENTAL

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.

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Probiotic 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.

Probiotic

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Recent Covid-19 infection (less than 4 weeks since the first negative SARS-CoV-2 (self) test after the infection)
• Specific dietary restrictions (e.g. active phase of low Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols (FODMAP) diet)
• Any dietary mode excluding passage of food via GI tract
• 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)
• History of confirmed Clostridium difficile infection in the last 6 months
• Known allergy or hypersensitivity to any ingredients of the IP

Sponsors & Collaborators

• The Archer-Daniels-Midland Company: lead
• Analyze & Realize: collaborator

Study Sites (1)

analyze & realize GmbH

Berlin, Weißenseer Weg, 10369, Germany

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: May 6, 2023
• Study Start: May 9, 2023
• Primary Completion: July 25, 2024
• Study Completion: July 25, 2024
• Last Updated: April 9, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)