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The Efficacy of a Probiotic for Antibiotic Associated Gastrointestinal Symptoms (PANDA)

Primary Purpose

Antibiotic-associated Diarrhea

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Probiotic
Placebo
Sponsored by
The Archer-Daniels-Midland Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Antibiotic-associated Diarrhea focused on measuring Probiotic, Antibiotic-associated Diarrhea, GI microbiome, Lactobacillus, Bifidobacterium

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 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

Sites / Locations

  • analyze & realize GmbHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic

Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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.
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
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
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.
Difference in Stool Frequency
Difference in weekly average stool frequency throughout the period between baseline (V1) and day 20 - 25 (V3).
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.
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.
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
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)
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)
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)
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)

Full Information

First Posted
March 27, 2023
Last Updated
July 18, 2023
Sponsor
The Archer-Daniels-Midland Company
Collaborators
Analyze & Realize
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1. Study Identification

Unique Protocol Identification Number
NCT05845073
Brief Title
The Efficacy of a Probiotic for Antibiotic Associated Gastrointestinal Symptoms
Acronym
PANDA
Official Title
A Pilot Clinical Trial Assessing the Effect of Probiotic Supplementation on Antibiotic Associated Gastrointestinal Symptoms and Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 9, 2023 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Archer-Daniels-Midland Company
Collaborators
Analyze & Realize

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antibiotic-associated Diarrhea
Keywords
Probiotic, Antibiotic-associated Diarrhea, GI microbiome, Lactobacillus, Bifidobacterium

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants in this arm will receive an equivalent placebo for the duration of antibiotic therapy, and 14 day thereafter.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Participants in this arm will receive an equivalent placebo for for the duration of antibiotic therapy, and 14 day thereafter.
Primary Outcome Measure Information:
Title
Change in the Gastrointestinal Symptom Rating Score - Irritable Bowel Syndrome (GSRS-IBS)
Description
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
Time Frame
Baseline (V1), Day 6 - 11 (V2)
Secondary Outcome Measure Information:
Title
Difference in the Gastrointestinal Symptom Rating Score - Irritable Bowel Syndrome (GSRS-IBS)
Description
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
Time Frame
Day 6 - 11 (V2), Day 20 - 25 (V3)
Title
Difference in the Gastrointestinal Symptom Rating Score - Irritable Bowel Syndrome (GSRS-IBS)
Description
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
Time Frame
Baseline (V1), Day 20 - 25 (V3)
Title
Incidence of antibiotic-associated diarrhoea (AAD)
Description
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
Time Frame
Through study completion, an expected average of 21 days
Title
Duration of antibiotic associated diarrhoea (AAD)
Description
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.
Time Frame
Through study completion, an expected average of 21 days
Title
Difference in individual scores of Gastrointestinal Symptom Rating Score - Irritable Bowel Syndrome (GSRS-IBS)
Description
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
Time Frame
Day 6 - 11 (V2), Day 20 - 25 (V3)
Title
Difference in individual scores of Gastrointestinal Symptom Rating Score - Irritable Bowel Syndrome (GSRS-IBS)
Description
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
Time Frame
Baseline (V1), Day 6 - 11 (V2), Day 20 - 25 (V3)
Title
Difference in Stool Consistency
Description
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.
Time Frame
Through study completion, an expected average of 21 days
Title
Difference in Stool Frequency
Description
Difference in weekly average stool frequency throughout the period between baseline (V1) and day 20 - 25 (V3).
Time Frame
Through study completion, an expected average of 21 days
Title
Percentage with diarrhoea
Description
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.
Time Frame
Through study completion, an expected average of 21 days
Title
Duration of diarrhoea
Description
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.
Time Frame
Through study completion, an expected average of 21 days
Title
Metabolomic Analysis of Faecal Samples
Description
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
Time Frame
Baseline (V1), Day 6 - 11 (V2), Day 20 - 25 (V3)
Title
Difference in Short Form 12 (SF-12) - Mental Component Score
Description
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)
Time Frame
Day 6 - 11 (V2), Day 20 - 25 (V3)
Title
Difference in Short Form 12 (SF-12) - Physical Component Score
Description
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)
Time Frame
Day 6 - 11 (V2), Day 20 - 25 (V3)
Title
Difference in Short Form 12 (SF-12) - Mental Component Score (MCS)
Description
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)
Time Frame
Baseline (V1), Day 6 - 11 (V2), Day 20 - 25 (V3)
Title
Difference in Short Form 12 (SF-12) - Physical Component Score (PCS)
Description
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)
Time Frame
Baseline (V1), Day 6 - 11 (V2), Day 20 - 25 (V3)
Other Pre-specified Outcome Measures:
Title
Evaluation of Study Benefit
Description
Evaluation of benefit at study end by subject and the investigator (4 point scale, higher scores mean a better evaluation of the study product)
Time Frame
Day 20 - 25 (V3)
Title
Matching records between blinded self-assessment
Description
Percentage of subject with matching records of blinded self-assessment concerning the IP type they received (verum, placebo) and the actual IP assignment
Time Frame
Day 20 - 25 (V3)
Title
Stool Microbiome Assessment
Description
Difference in Stool Microbiome analysis findings at baseline (V1), Day 6 - 11 (V2) and Day 20 - 25 (V3)
Time Frame
Baseline (V1), Day 6 - 11 (V2), Day 20 - 25 (V3)
Title
Change in body weight
Description
Change in body weight, measured in kilograms (Kg) between baseline (V1) and Day 20 - 25 (V3)
Time Frame
Baseline (V1), Day 20 - 25 (V3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ADM Medical Team
Phone
+44 1460 243 230
Email
medical@protexin.com
Facility Information:
Facility Name
analyze & realize GmbH
City
Berlin
State/Province
Weißenseer Weg 111
ZIP/Postal Code
10369
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liana Vismane
Email
lvismane@a-r.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Efficacy of a Probiotic for Antibiotic Associated Gastrointestinal Symptoms

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