Conditions Influencing Health Status
Conditions
Keywords
Probiotic, Immunity, Gastrointestinal symptoms
Brief summary
The present report describes the design of a clinical trial performed on healthy adult individuals to check whether the daily intake of the new Hero strains contribute to intestinal colonization, under safe and tolerable conditions, with a positive contribution to health and wellbeing of healthy individuals. Daily intake of one or several probiotic strains, (CNCM I-4034, CNCM I-4035, CNCM I-4036), increases intestinal microbiota in healthy adults, being safe and well tolerated. The regular intake has positive effects on the gastrointestinal and immune system.
Detailed description
The project will be based on a double-blind, randomized, and placebo-controlled clinical trial. It will be multi-Centre, with four groups plus a control group. The colonization performed by the strains and the modification of the intestinal microbiota will be evaluated by means of strain identification with RT-PCR equipped with specific primers, and bacterial population counting with in situ immunofluorescence techniques. The safety of strain intake will be evaluated with physical examination, blood parameters, and test son faeces to check for resistance to ampicillin and tetracycline by lactic flora. Tolerance will be evaluated by means of the record of gastrointestinal symptoms and the record of aspect and frequency of faeces. The effect on the systemic and adaptive immune system will be measured by means of lymphocyte populations and plasma cytokine present on blood, IgAs on serum, saliva and faeces. Also AGCC on faeces.
Interventions
OTHERProbiotic CNCM I-4034
Probiotic CNCM I-4034 in a concentration of 9x10E9 cfu (colony forming unit) per day during 28 days.
OTHERProbiotic CNCM I-4035
9x10E9 cfu (colony forming unit) per day during 28 days.
OTHERProbiotic CNCM I-4036
9x10E9 cfu (colony forming unit) per day during 28 days.
OTHERProbiotics CNCM I-4035 and CNCM I-4036
9x10E9 cfu (colony forming unit) per day during 28 days.
OTHERPlacebo
Placebo capsule for 28 days.
Sponsors
Universidad de Granada
University of Valencia
Universidad de Murcia
Hero Institute for Infant Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult * Age: 18-50 years * Normal defecation * Normal blood parameters * Body Mass Index: 18-30
Exclusion criteria
* Pregnancy * Lactation * Antibiotic treatment * Gastrointestinal disease * Diarrhoea * Constipation * Diabetes * Abnormal blood pressure * Allergy * Smoker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal Tolerance After Probiotic Consumption. | 4 weeks of the treatments. Daily recorded. | Tolerance of these probiotic strains was determined using the gastrointestinal symptom rating scale (GSRS), daily recorded gastrointestinal symptoms and defecation frequency.Intolerance was defined as a symptom score of 2 or higher on the GSRS. The unit of measure is the number of participants was tolerant to the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal and Immune Effects of Probiotics Consumption. | At Time zero, after 4 weeks, and 2 later. | Effect on the systemic and adaptive immune system. This will be measured by means of lymphocite populations and plasma cytokine present on blood, IgAs on serum (at zero time and after four weeks of treatment), IgAs on saliva and faeces and AGCC (at zero time and after four weeks and two more weeks). Gastrointestinal effects will be measured by means of gastrointestinal symptoms record and frequency and aspect of faeces, during the treatment and the following two weeks (wash-out period). |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A Volunteers are given strain CNCM I-4034.
Probiotic CNCM I-4034: 9x10E9 cfu (colony forming unit) per day during 28 days. | 20 |
| Group B Volunteers receive Probiotic CNCM I-4035.
Probiotic CNCM I-4035: 9x10E9 cfu (colony forming unit) per day during 28 days. | 20 |
| Group C Volunteers are given Probiotic CNCM I-4036.
Probiotic CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days. | 20 |
| Group D Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.
Probiotics CNCM I-4035 and CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days. | 20 |
| Group E Volunteers receive a placebo.
Placebo capsule: Placebo capsule for 28 days. | 20 |
| Total | 100 |
Baseline characteristics
| Characteristic | Group C | Group B | Group A | Total | Group E | Group D |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 20 Participants | 100 Participants | 20 Participants | 20 Participants |
| Age, Continuous | 29.4 years STANDARD_DEVIATION 7.1 | 27 years STANDARD_DEVIATION 5.7 | 28.7 years STANDARD_DEVIATION 5 | 28.78 years STANDARD_DEVIATION 1.22 | 28.5 years STANDARD_DEVIATION 7.6 | 30.3 years STANDARD_DEVIATION 7.6 |
| Region of Enrollment Spain | 20 participants | 20 participants | 20 participants | 100 participants | 20 participants | 20 participants |
| Sex: Female, Male Female | 11 Participants | 10 Participants | 11 Participants | 54 Participants | 11 Participants | 11 Participants |
| Sex: Female, Male Male | 9 Participants | 10 Participants | 9 Participants | 46 Participants | 9 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
Gastrointestinal Tolerance After Probiotic Consumption.
Tolerance of these probiotic strains was determined using the gastrointestinal symptom rating scale (GSRS), daily recorded gastrointestinal symptoms and defecation frequency.Intolerance was defined as a symptom score of 2 or higher on the GSRS. The unit of measure is the number of participants was tolerant to the intervention.
Time frame: 4 weeks of the treatments. Daily recorded.
Population: Calculation of simple size was based on the variance in the probiotic strain count (log strain CFU/g) in feces and a difference of 25% compared with the placebo. alfa: 0.05 power 90%
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A | Gastrointestinal Tolerance After Probiotic Consumption. | 20 participants |
| Group B | Gastrointestinal Tolerance After Probiotic Consumption. | 20 participants |
| Group C | Gastrointestinal Tolerance After Probiotic Consumption. | 20 participants |
| Group D | Gastrointestinal Tolerance After Probiotic Consumption. | 20 participants |
| Group E | Gastrointestinal Tolerance After Probiotic Consumption. | 20 participants |
Secondary
Gastrointestinal and Immune Effects of Probiotics Consumption.
Effect on the systemic and adaptive immune system. This will be measured by means of lymphocite populations and plasma cytokine present on blood, IgAs on serum (at zero time and after four weeks of treatment), IgAs on saliva and faeces and AGCC (at zero time and after four weeks and two more weeks). Gastrointestinal effects will be measured by means of gastrointestinal symptoms record and frequency and aspect of faeces, during the treatment and the following two weeks (wash-out period).
Time frame: At Time zero, after 4 weeks, and 2 later.