Antibiotic Side EffectFANTIBNCT05355571
The Impact of Probiotic Supplementation on Antibiotic Induced Changes in Gastrointestinal Function And/or Faecal Microbiota Composition
A study testing LAB4 + Saccharomyces boulardii in people with Antibiotic Side Effect, run by Cultech Ltd at 1 site in Bulgaria.
Trial summary
To investigate whether probiotic supplementation during the consumption of oral antibiotics can impact gastrointestinal responses and/or the regrowth of the gut microbiota. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Antibiotic Side Effect
- What is being tested?
- LAB4 + Saccharomyces boulardii
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBulgaria
- Study dates
- 18 Nov 2022to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Probiotic Supplementation on Antibiotic Induced Changes in Gastrointestinal Function And/or Faecal Microbiota Composition (FANTIB)
To investigate whether probiotic supplementation during the consumption of oral antibiotics can impact gastrointestinal responses and/or the regrowth of the gut microbiota.
Read the 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.
- Conditions
- Antibiotic Side Effect
- Being tested
- LAB4 + Saccharomyces boulardii, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAB4 + Saccharomyces boulardiiDietary supplement
Probiotic containing lactic acid bacteria and Saccharomyces boulardii at a dose of 35 billion per day
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: LAB4 + Saccharomyces boulardii |
| Placebo | Placebo comparator | Participants will consume a placebo alongside an oral antibiotic at standard dosage administered for fixed period Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: One month post antibiotic treatment/ probiotic supplementation
Secondary outcomes (3)
Quality of life questionnaires to measure quality of life post 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.
Measured: One month post antibiotic treatment/ probiotic supplementation
Questionnaire of gastrointestinal health to measure gastrointestinal health post 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.
Measured: One month post antibiotic treatment/ probiotic supplementation
Bowel habit diary to measure gastrointestinal health post 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).
Measured: One month post antibiotic treatment/ probiotic supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start18 Nov 2022
- Primary completion17 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic Side EffectStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cultech Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Comac Medical
- Responsible party
- Sponsor
- Investigators
- Aleksandrina Panteleeva, Principal investigator, Comac Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355571
- Sponsor's protocol ID
- FANTIB
- Acronym
- FANTIB
- Status last verified
- Sep 2024
- First submitted
- 19 Apr 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Probiotic Supplementation on Antibiotic Induced Changes in Gastrointestinal Function And/or Faecal Microbiota Composition (FANTIB)
- ClinicalTrials.gov ID
- NCT05355571
- Acronym / sponsor ID
- FANTIB / FANTIB
- Conditions
- Antibiotic Side Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cultech LtdIndustry (pharma, biotech, devices)
- Collaborators
- Comac Medical
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- 17 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Dietary Supplement: LAB4 + Saccharomyces boulardiiParticipants 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 |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants will consume a placebo alongside an oral antibiotic at standard dosage administered for fixed period |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAB4 + Saccharomyces boulardiiProbiotic containing lactic acid bacteria and Saccharomyces boulardii at a dose of 35 billion per day | Dietary supplement | Active |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
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.
3 secondary outcomes
Quality of life questionnaires to measure quality of life post probiotic supplementation
Time frame: One month post antibiotic treatment/ probiotic supplementation
Questionnaire of gastrointestinal health to measure gastrointestinal health post probiotic supplementation.
Time frame: One month post antibiotic treatment/ probiotic supplementation
Bowel habit diary to measure gastrointestinal health post probiotic supplementation.
Time frame: One month post antibiotic treatment/ probiotic supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleksandrina Panteleeva principal investigator
Comac Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LAB4 + Saccharomyces boulardii in people with Antibiotic Side Effect, run by Cultech Ltd at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.