The Impact of Probiotic Supplementation on Antibiotic Induced Changes in Gastrointestinal Function and/or Faecal Microbiota Composition (FANTIB)

• ClinicalTrials.gov Identifier: NCT05355571
• Recruitment Status: Completed
• First Posted: May 2, 2022
• Last Update Posted: July 6, 2023
• Sponsor: Cultech Ltd
• Collaborator: Comac Medical
• Information provided by (Responsible Party): Cultech Ltd

Tracking Information

• First Submitted Date: April 19, 2022
• First Posted Date: May 2, 2022
• Last Update Posted Date: July 6, 2023
• Actual Study Start Date: November 18, 2022
• Actual Primary Completion Date: January 17, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 3, 2022)

• Microbiological analysis of stool samples as a measure of abundance within the microbiota post antibiotic consumption. [ Time Frame: One month post antibiotic treatment/ probiotic supplementation ]
  Stool samples will be streaked out onto specific agar to measure the viable abundance of specific bacteria and fungi including; Lactobacillus, Enterobacteria, Enterococci, Staphylococci, Yeast, Bifidobacteria and Bacteroides. Microbiological counts (Log10 CFU/g(Colony forming unit/g)) will then be analysed and compared.
• Next generation sequencing (NGS) analysis of stool samples as a measure of microbiome diversity and abundance within the microbiota post antibiotic consumption. [ Time Frame: One month post antibiotic treatment/ probiotic supplementation ]
  Genomic DNA will be extracted from stool samples and subsequently run through Illumina MiSeq to produce sequencing data which can be used to analyse diversity (Alpha and Beta) changes in the microbiome along with changes in abundance of taxa.

Original Primary Outcome Measures (submitted: April 26, 2022)

• Microbiological analysis of stool samples as a measure of abundance within the microbiota post antibiotic consumption. [ Time Frame: One month post antibiotic treatment/ probiotic supplementation ]
  Stool samples will be streaked out onto specific agar to measure the viable abundance of specific bacteria and fungi including; Lactobacillus, Enterobacteria, Enterococci, Staphylococci, Yeast, Bifidobacteria and Bacteroides. Microbiological counts (Log10 CFU/g) will then be analyised and compared.
• Next generation sequencing (NGS) analysis of stool samples as a measure of microbiome diversity and abundance within the microbiota post antibiotic consumption. [ Time Frame: One month post antibiotic treatment/ probiotic supplementation ]
  Genomic DNA will be extracted from stool samples and subsequently run through Illumina MiSeq to produce sequencing data which can be used to analyse diversity (Alpha and Beta) changes in the microbiome along with changes in abundance of taxa.

Current Secondary Outcome Measures (submitted: May 3, 2022)

• Quality of life questionnaires to measure quality of life post probiotic supplementation [ Time Frame: One month post antibiotic treatment/ probiotic supplementation ]
  Quality of life questionnaires will be completed at the start, post antibiotic treatment and end of study. Questionnaires are rated on a scale from 1 (very poor) to 10 (very good) and questions include; General wellness, state of health, state of energy, state of mood and sleep quality.
• Questionnaire of gastrointestinal health to measure gastrointestinal health post probiotic supplementation. [ Time Frame: One month post antibiotic treatment/ probiotic supplementation ]
  A daily gastrointestinal tract symptom record sheet which involves ticking off symptoms is present. Symptoms include; Abdominal pains, Bloating, stomach rumbling, vomiting/nausea, acid regurgitation/heartburn, increased flatulence and increased belching.
• Bowel habit diary to measure gastrointestinal health post probiotic supplementation. [ Time Frame: One month post antibiotic treatment/ probiotic supplementation ]
  A bowel habit diary questionnaire to be completed for every attempted bowel motion during the study. Questions include; 1. Were you able to pass a stool?, 2. Did you feel an urgent need to pass the bowel motion?, 3. Did you strain to start the bowel motion?, 4. Were you left with a feeling of incomplete evacuation?, 5. Please rate the appearance of your bowel motion using the bristol stool score (1-7).

Original Secondary Outcome Measures (submitted: April 26, 2022)

• Quality of life questionnaires to measure quality of life post probiotic supplementation [ Time Frame: One month post antibiotic treatment/ probiotic supplementation ]
  Quality of life questionnaires will be completed at the start, post antibiotic treatment and end of study. Questionnaires are rated on a scale from 1 (very poor) to 10 (very good) and questions include; General wellness, state of health, state of energy, state of mood and sleep quality.
• Questionnaire of gastrointestinal health to measure gastrointestinal health post probiotic supplementation. [ Time Frame: One month post antibiotic treatment/ probiotic supplementation ]
  A daily gastrointestinal tract symptom record sheet which involves ticking off symptoms is present. Symptoms include; Abdominal pains, Bloating, stomach rumbling, vomiting/nauea, acid regurgitation/heatburn, increased flatulence and increaed belching.
• Bowel habit diary to measure gastrointestinal health post probiotic supplementation. [ Time Frame: One month post antibiotic treatment/ probiotic supplementation ]
  A bowel habit diary questionnaire to be completed for every attempted bowel motion during the study. Questions include; 1. Were you able to pass a stool?, 2. Did you feel an urgent need to pass the bowel motion?, 3. Did you strain to start the bowel motion?, 4. Were you left with a feeling of incomplete evacuation?, 5. Please rate the appearance of your bowel motion using the bristol stool score (1-7).

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Impact of Probiotic Supplementation on Antibiotic Induced Changes in Gastrointestinal Function and/or Faecal Microbiota Composition
• Official Title: The Impact of Probiotic Supplementation on Antibiotic Induced Changes in Gastrointestinal Function and/or Faecal Microbiota Composition (FANTIB)
• Brief Summary: To investigate whether probiotic supplementation during the consumption of oral antibiotics can impact gastrointestinal responses and/or the regrowth of the gut microbiota.

Detailed Description

The human gut (gastrointestinal tract) is home to more than a trillion mostly "friendly bacteria" = the gut microbiota - that support the well-being and health of an individual through a variety of mechanisms. Antibiotic treatment impacts on the microbiota and reduces the overall numbers and diversity which causes metabolic shifts and increases susceptibility to colonization by potentially pathogenic and/or resistant bacteria and thereby increases the risk of bacterial antibiotic resistance. This trial aims to investigate whether probiotic supplementation during the consumption of oral antibiotics can impact the gastrointestinal responses and/or the composition/functionality of the regrowth of the gut microbiota.

The trial will be a double blinded, placebo-controlled study consisting of 50 participants (25 per group), aged 18-65, to be enrolled after being prescribed a 5 to 10-day course of antibiotics. The study will be randomized through an independent statistician.

The study will involve three site visits, the first visit occurs at enrolment when the participant is randomised and measures of height, body weight and blood pressure are taken. The participants will also answer a quality of life questionnaire at visit 1 and will receive the study intervention. A stool sample will be collected at this visit (if possible) and the participant will be given two more stool sample collection kits, a gastrointestinal tract symptom record sheet too b completed daily throughout the study and a bowel habit diary to be completed per defecation..

The second visit will take place the day after the completion of the prescribed antibiotic course and at this visit participants will return a stool sample collected at home the previous day, and asked to complete another quality of life questionnaire. The final visit will take place at around day 30, when again they will return a stool sample collected within 48 hours of the visit, return all gastrointestinal symptom record sheets and bowel habit diaries as well as returning any unused intervention (for compliance monitoring). Scientists will use the information and samples collected to determine if there was any benefit to taking the probiotic supplement.

It is considered that the daily intake of the probiotics will improve general wellbeing and mental health. Due to the chance that the participant may receive the placebo, it is perceived that these benefits will be confined to the participants who are randomly assigned the intervention. Participation in the study will bring more information and will improve our understanding of the benefits of daily probiotic supplementation.

There have been no adverse reactions associated with the regular consumption of this probiotic product but participants may experience mild side effects such as a change in bowel habit and/ or increased flatulence (intestinal gas) during the first few days of taking the supplement.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Supportive Care
• Condition: Antibiotic Side Effect

Intervention

• Dietary Supplement: LAB4 + Saccharomyces boulardii
  Probiotic containing lactic acid bacteria and Saccharomyces boulardii at a dose of 35 billion per day
• Dietary Supplement: Placebo
  Placebo

Study Arms

• Active Comparator: Active
  Participants will consume a probiotic containing lactic acid bacteria and Saccharomyces boulardii at a dose of 35 billion per day for 10 days alongside an oral antibiotic at standard dosage administered for fixed period
  Intervention: Dietary Supplement: LAB4 + Saccharomyces boulardii
• Placebo Comparator: Placebo
  Participants will consume a placebo alongside an oral antibiotic at standard dosage administered for fixed period
  Intervention: Dietary Supplement: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 26, 2022): 50
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: January 30, 2023
• Actual Primary Completion Date: January 17, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Male or female, aged 18-65
2. Receiving a 5 to 10 day course of oral antibiotics
3. Willing to provide 3 faecal samples over the duration of the study
4. Willing to refrain from taking non-GP (general practitioner) prescribed antibiotics

Exclusion Criteria:

1. Consumed regular probiotic supplementation within the last 1 month prior to the study
2. Consumed any antibiotic within the last 3 months
3. Prescribed antibiotics for a gastrointestinal related issue
4. Diagnosed with diabetes
5. Are immunodeficient or undergoing immunosuppressive therapy
6. Diagnosed with arrhythmia, ventricular extrasystole, atrioventricular block or other cardiovascular disease deemed as a risk by study doctor
7. Diagnosed with a cardiovascular disease
8. Pregnancy or planning pregnancy
9. Diagnosed with a severe systemic disease e.g. cancer, dementia, advanced organ failure.
10. Unexplained loss of weight in recent months

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Bulgaria

Administrative Information

• NCT Number: NCT05355571
• Other Study ID Numbers: FANTIB
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol

• Current Responsible Party: Cultech Ltd
• Original Responsible Party: Same as current
• Current Study Sponsor: Cultech Ltd
• Original Study Sponsor: Same as current
• Collaborators: Comac Medical

Investigators

• Principal Investigator: Aleksandrina Panteleeva; Comac Medical

• PRS Account: Cultech Ltd
• Verification Date: May 2022