SurgeryPhase 2NCT04742322
Efficacy of Bifidobacterium Lactis CCT 7858 in Adults Using Antibiotics
A Phase 2 study testing Bifidobacterium Lactis CCT7858 and Maltodextrin in people with Surgery and Infection, run by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude at 1 site in Brazil.
Trial summary
To evaluate the effectiveness of the probiotic Bifidobacterium lactis CCT 7858 in preventing and / or improving gastrointestinal symptoms in adults using antibiotics. For this, a randomized, double-blind, placebo-controlled clinical trial will be carried out. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Bifidobacterium Lactis CCT7858 and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteBrazil
- Study dates
- 11 Jan 2021to 30 Dec 2021
- Phase
- Phase 2
- 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
- Adults of both sexes;
- Aged between 18 and 65 years;
- 24 hours after starting antibiotic treatment;
- Antibiotics tretament for a minimum of 3 days and a maximum of 14 days;
- Informed consent must be signed before starting the study.
Who cannot join
- blood pressure is outside the normal range (systolic blood pressure> 140, systolic blood pressure <90, diastolic> 90);
- history of heart disease, including heart valve disease or heart surgery, any implantable device;
- continuous or recent use of antibiotic therapy in the 30 days prior to the first administration of the study supplement;
- ostomates or users of parenteral nutrition;
- immunosuppressive therapy or any health condition that causes immunosuppression (including hematology malignancies, AIDS);
- Crohn's disease or ulcerative colitis;
Show all 12Show fewer
- previous infection with Clostridium difficile documented less than 3 months before the start of the study;
- history of daily consumption of probiotics, fermented milk;
- individuals known to have demonstrated a previous reaction, including anaphylaxis, to any substance in the study product composition;
- individuals with active diarrhea (3 or more liquid stools per 24 hour period);
- pregnant women at the time of recruitment or planning to become pregnant during the study;
- Individuals with concomitant participation in another clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Using Bifidobacterium Lactis CCT 7858 in Improving Gastrointestinal Symptoms in Adults Using Antibiotics
To evaluate the effectiveness of the probiotic Bifidobacterium lactis CCT 7858 in preventing and / or improving gastrointestinal symptoms in adults using antibiotics. For this, a randomized, double-blind, placebo-controlled clinical trial will be carried out. The sample will be composed of adults who will be recruited in a hospital, who have been hospitalized and receive a prescription for antibiotics. The individuals will be separated into two groups: intervention and placebo. 104 patients will be included, 52 for each group. Inclusion criteria:
adults of both sexes and aged between 18 and 65 years, who have been recruited within 24 hours after starting antibiotic treatment, the prescribed treatment should be with antibiotics for a minimum of 9 days and a maximum of 14 days. The informed consent must be signed before starting the study.
Read the detailed description
Two groups (placebo and intervention) will receive supplementation, the Placebo group will receive maltodextrin and Intervention group will receive probiotic B. lactis, that should be consumed for a period of 10 to 14 days depending on the duration of administration of the antibiotic (should be consumed until 7 day after the last antibiotic).
As a way of ensuring an equal distribution of the number of participants in the study groups and ensuring that the groups are similar, a randomization by blocks will be carried out and stratified by sex and age. The program that will be used to generate random numbers is the Research Randomizer Form v4.0. The packaging of both supplements will be identical except for the color, which will distinguish maltodextrin from probiotic.
Supplements will be delivered by a research collaborator as a way to guarantee blinding.
The probiotic to be supplied will be Bifidobacterium lactis CCT 7858 (GABBIA® Biotechnology and Development, Santa Catarina, Brazil). The probiotic will be offered in capsule and in the concentration of 9x10 10 UFC.
The groups will be evaluated in two moments: baseline and final.
The evaluation of the individuals will be performed through the collection of the following data: necessity and duration of antibiotic therapy (type of antibiotic) used while participating in the study.
Blood pressure will also be assessed.
Body weight will be measured. The body mass index will be calculated
In order to verify the tolerance and effectiveness of the supplements, questions regarding the frequency and consistency of feces will be asked, evaluated using the Bristol scale (1: separate pieces, 2: segmented sausage shape, 3: cracked sausage shape, 4: smooth and soft sausage shape, 5: soft pieces, 6: aerated pieces, 7: watery) and gastrointestinal symptoms (excess flatulence in the rectum, abdominal distention, borborisms, abdominal pain and the occurrence of vomiting or nausea), will be assessed daily throughout the study period using a five-point scale (0: none, 1: weak, 2: moderate, 3: strong, 4: very strong).
In addition, the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire will be used to assess symptomatic evolution.
Before starting the intervention, each participant will record the frequency of defecation, characteristics and feeling of defecation (as an initial assessment) and daily after the start of the intervention.
They will fill out a questionnaire about bowel function weekly.
Changes in quality of life during the study will be measured by the SF-36 questionnaire, which consists of 36 items encompassed in 8 scales or components: functional capacity, physical aspects, pain, general health, vitality, social aspects, emotional aspects, mental health and another question of comparative evaluation between the current health conditions and that of a year ago.
The data will be organized and recorded in a database in the Microsoft Office Excel 2007® program with double entry. The statistical analysis will be performed in the Statistical statistical program Package for the Social Sciences (SPSS) version 24.0 for Windows.
Quantitative variables will be described and presented in mean and standard deviation from the mean if the distribution is symmetrical or in median and interquartile range if it is asymmetric. Nominal variables will be described in frequency categories as of the appearance in the described groups. To assess the distribution of data, the Shapiro-Wilk normality test will be applied. If the data is asymmetric, it will undergo logarithmic normalization or the non-parametric test will be used.
The intragroup changes will be analyzed by the difference (Basal and End) between the variables, using the paired Student t test or Wilcoxon.
When including 60% of patients, the data will be evaluated by an independent researcher to check whether the difference estimates are true. If necessary, the sample calculation will be reassessed
The assessment of treatment adherence will be measured by self-report on the daily assessment and telephone interviews, and at the end of the study you will be asked to deliver the supplement package.
- Being tested
- Bifidobacterium Lactis CCT7858, Maltodextrin
- Keywords
- probiotic, antibiotic, B lactis
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium Lactis CCT7858Dietary supplement
Probiotic B Lactis
MaltodextrinDietary supplement
Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 1x capsule/day - maltodextrin, period of 10 to 14 days Receives: Dietary Supplement: Maltodextrin |
| B Lactis | Experimental | 1x capsule/day - 9x10x10 UFC, period of 10 to 14 days Receives: Dietary Supplement: Bifidobacterium Lactis CCT7858 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased diarrhea
Decreased diarrhea through bristol scale. The Bristol stool scale is a diagnostic medical tool designed to classify the form of human faeces into seven categories. Categories: 1 - 7
Measured: 10 - 14 days
Secondary outcomes (2)
Improve in Quality of life
Improved quality of life through Short Form 36 Health Survey (SF-36) scale/questionare. The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Measured: 10-14 days
Improve of gastrointestinal symptoms
Improve of gastrointestinal symptoms through Gastrointestinal Symptom Rating Scale (GSRS). The GSRS is a disease-specific instrument. The 15 items combine into five symptom clusters: Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. Each item is rated on a 7-point Likert scale. Scale 7 refers to worse symptoms
Measured: 10 - 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start11 Jan 2021
- Primary completion11 Jan 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felipe Dal Pizzol, Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742322
- Sponsor's protocol ID
- 40641120900005364
- Status last verified
- Jun 2022
- First submitted
- 21 Jan 2021
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Using Bifidobacterium Lactis CCT 7858 in Improving Gastrointestinal Symptoms in Adults Using Antibiotics
- ClinicalTrials.gov ID
- NCT04742322
- Acronym / sponsor ID
- 40641120900005364
- Keywords
- probiotic, antibiotic, B lactis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da SaudeUniversity, hospital or other
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 11 Jan 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 8 Feb 2021 (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 evaluate the effectiveness of the probiotic Bifidobacterium lactis CCT 7858 in preventing and / or improving gastrointestinal symptoms in adults using antibiotics. For this, a randomized, double-blind, placebo-controlled clinical trial will be carried out. The sample will be composed of adults who will be recruited in a hospital, who have been hospitalized and receive a prescription for antibiotics. The individuals will be separated into two groups: intervention and placebo. 104 patients will be included, 52 for each group. Inclusion criteria:
adults of both sexes and aged between 18 and 65 years, who have been recruited within 24 hours after starting antibiotic treatment, the prescribed treatment should be with antibiotics for a minimum of 9 days and a maximum of 14 days. The informed consent must be signed before starting the study.
Detailed description
Two groups (placebo and intervention) will receive supplementation, the Placebo group will receive maltodextrin and Intervention group will receive probiotic B. lactis, that should be consumed for a period of 10 to 14 days depending on the duration of administration of the antibiotic (should be consumed until 7 day after the last antibiotic).
As a way of ensuring an equal distribution of the number of participants in the study groups and ensuring that the groups are similar, a randomization by blocks will be carried out and stratified by sex and age. The program that will be used to generate random numbers is the Research Randomizer Form v4.0. The packaging of both supplements will be identical except for the color, which will distinguish maltodextrin from probiotic.
Supplements will be delivered by a research collaborator as a way to guarantee blinding.
The probiotic to be supplied will be Bifidobacterium lactis CCT 7858 (GABBIA® Biotechnology and Development, Santa Catarina, Brazil). The probiotic will be offered in capsule and in the concentration of 9x10 10 UFC.
The groups will be evaluated in two moments: baseline and final.
The evaluation of the individuals will be performed through the collection of the following data: necessity and duration of antibiotic therapy (type of antibiotic) used while participating in the study.
Blood pressure will also be assessed.
Body weight will be measured. The body mass index will be calculated
In order to verify the tolerance and effectiveness of the supplements, questions regarding the frequency and consistency of feces will be asked, evaluated using the Bristol scale (1: separate pieces, 2: segmented sausage shape, 3: cracked sausage shape, 4: smooth and soft sausage shape, 5: soft pieces, 6: aerated pieces, 7: watery) and gastrointestinal symptoms (excess flatulence in the rectum, abdominal distention, borborisms, abdominal pain and the occurrence of vomiting or nausea), will be assessed daily throughout the study period using a five-point scale (0: none, 1: weak, 2: moderate, 3: strong, 4: very strong).
In addition, the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire will be used to assess symptomatic evolution.
Before starting the intervention, each participant will record the frequency of defecation, characteristics and feeling of defecation (as an initial assessment) and daily after the start of the intervention.
They will fill out a questionnaire about bowel function weekly.
Changes in quality of life during the study will be measured by the SF-36 questionnaire, which consists of 36 items encompassed in 8 scales or components: functional capacity, physical aspects, pain, general health, vitality, social aspects, emotional aspects, mental health and another question of comparative evaluation between the current health conditions and that of a year ago.
The data will be organized and recorded in a database in the Microsoft Office Excel 2007® program with double entry. The statistical analysis will be performed in the Statistical statistical program Package for the Social Sciences (SPSS) version 24.0 for Windows.
Quantitative variables will be described and presented in mean and standard deviation from the mean if the distribution is symmetrical or in median and interquartile range if it is asymmetric. Nominal variables will be described in frequency categories as of the appearance in the described groups. To assess the distribution of data, the Shapiro-Wilk normality test will be applied. If the data is asymmetric, it will undergo logarithmic normalization or the non-parametric test will be used.
The intragroup changes will be analyzed by the difference (Basal and End) between the variables, using the paired Student t test or Wilcoxon.
When including 60% of patients, the data will be evaluated by an independent researcher to check whether the difference estimates are true. If necessary, the sample calculation will be reassessed
The assessment of treatment adherence will be measured by self-report on the daily assessment and telephone interviews, and at the end of the study you will be asked to deliver the supplement package.
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 |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Maltodextrin1x capsule/day - maltodextrin, period of 10 to 14 days |
| B Lactis | Experimental | Dietary Supplement: Bifidobacterium Lactis CCT78581x capsule/day - 9x10x10 UFC, period of 10 to 14 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults of both sexes;
- Aged between 18 and 65 years;
- 24 hours after starting antibiotic treatment;
- Antibiotics tretament for a minimum of 3 days and a maximum of 14 days;
- Informed consent must be signed before starting the study.
Key exclusion criteria (12 listed)
- blood pressure is outside the normal range (systolic blood pressure> 140, systolic blood pressure <90, diastolic> 90);
- history of heart disease, including heart valve disease or heart surgery, any implantable device;
- continuous or recent use of antibiotic therapy in the 30 days prior to the first administration of the study supplement;
- ostomates or users of parenteral nutrition;
- immunosuppressive therapy or any health condition that causes immunosuppression (including hematology malignancies, AIDS);
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 |
|---|---|---|
| Bifidobacterium Lactis CCT7858Probiotic B Lactis | Dietary supplement | B Lactis |
| MaltodextrinMaltodextrin | Dietary supplement | Placebo |
Primary outcome
Decreased diarrhea
Time frame: 10 - 14 days
Decreased diarrhea through bristol scale. The Bristol stool scale is a diagnostic medical tool designed to classify the form of human faeces into seven categories. Categories: 1 - 7
2 secondary outcomes
Improve in Quality of life
Time frame: 10-14 days
Improve of gastrointestinal symptoms
Time frame: 10 - 14 days
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 10 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bifidobacterium Lactis CCT7858 and Maltodextrin in people with Surgery and Infection, run by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude at 1 site in Brazil.
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 5 inclusion and 12 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 10 Jun 2022. 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 Brazil. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Decreased diarrhea (time frame: 10 - 14 days). 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 10 Jun 2022.