Antibiotic-associated DiarrheaPANDANCT05845073
The Efficacy of a Probiotic for Antibiotic Associated Gastrointestinal Symptoms
A study testing Probiotic in people with Antibiotic-associated Diarrhea, run by The Archer-Daniels-Midland Company at 1 site in Germany.
Trial summary
This study evaluates the effect of a multistrain probiotic on gastrointestinal (GI) complaints and diarrhoea in subjects receiving short-term antibiotic (AB) treatment Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Antibiotic-associated Diarrhea
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteGermany
- Study dates
- 9 May 2023to 25 Jul 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
- Previous adverse reactions to antibiotics
- Artificial or damaged heart valves
- 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
- History of or current abuse of drugs or medication
- Inability to comply with study requirements
- Subjects who are deprived of their freedom by administrative or legal decision or who are in guardianship
- Participation in another clinical study in the 30 days prior to V1 and during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Clinical Trial Assessing the Effect of Probiotic Supplementation on Antibiotic Associated Gastrointestinal Symptoms and Quality of Life
This study evaluates the effect of a multistrain probiotic on gastrointestinal (GI) complaints and diarrhoea in subjects receiving short-term antibiotic (AB) treatment
Read the 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
- Being tested
- Probiotic, Placebo
- Keywords
- Probiotic, Antibiotic-associated Diarrhea, GI microbiome, Lactobacillus, Bifidobacterium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary 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.
PlaceboDietary supplement
Participants in this arm will receive an equivalent placebo for for the duration of antibiotic therapy, and 14 day thereafter.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (V1), Day 6 - 11 (V2)
Secondary outcomes (15)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline (V1), Day 6 - 11 (V2), Day 20 - 25 (V3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start9 May 2023
- Primary completion25 Jul 2024
- Study completion25 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic-associated DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Archer-Daniels-Midland Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Analyze & Realize
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845073
- Sponsor's protocol ID
- CTB2022N104
- Acronym
- PANDA
- Status last verified
- Nov 2024
- First submitted
- 27 Mar 2023
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No