The Impact of Probiotic Supplementation on Antibiotic Induced Changes in Gastrointestinal Function And/or Faecal Microbiota Composition

NCT05355571 | Completed

• 1 other identifier: FANTIB
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Antibiotic Side Effect

Outcome Measures

Primary Outcomes (2)

• Microbiological analysis of stool samples as a measure of abundance within the microbiota post antibiotic consumption.

  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.

  One month post antibiotic treatment/ probiotic supplementation

• Next generation sequencing (NGS) analysis of stool samples as a measure of microbiome diversity and abundance within the microbiota post antibiotic consumption.

  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.

  One month post antibiotic treatment/ probiotic supplementation

Secondary Outcomes (3)

• Quality of life questionnaires to measure quality of life post probiotic supplementation

  One month post antibiotic treatment/ probiotic supplementation

• Questionnaire of gastrointestinal health to measure gastrointestinal health post probiotic supplementation.

  One month post antibiotic treatment/ probiotic supplementation

• Bowel habit diary to measure gastrointestinal health post probiotic supplementation.

  One month post antibiotic treatment/ probiotic supplementation

Study Arms (2)

Active

ACTIVE COMPARATOR

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

Dietary Supplement: LAB4 + Saccharomyces boulardii

Placebo

PLACEBO COMPARATOR

Participants will consume a placebo alongside an oral antibiotic at standard dosage administered for fixed period

Dietary Supplement: Placebo

Interventions

LAB4 + Saccharomyces boulardii DIETARY_SUPPLEMENT

Probiotic containing lactic acid bacteria and Saccharomyces boulardii at a dose of 35 billion per day

Active

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cultech Ltd: lead
• Comac Medical: collaborator

Study Sites (1)

Comac Medical

Sofia, Bulgaria

Location

Study Officials

• Aleksandrina Panteleeva

  Comac Medical

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: May 2, 2022
• Study Start: November 18, 2022
• Primary Completion: January 17, 2023
• Study Completion: January 30, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)