Is a mixture of prebiotics and probiotics effective on gut microorganisms and the immune system in the elderly?
| ISRCTN | ISRCTN37538805 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37538805 |
| Secondary identifying numbers | N/A |
- Submission date
- 31/01/2020
- Registration date
- 07/02/2020
- Last edited
- 28/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Plain English summary of protocol
Background and study aims
Elderly people often have a chronic state of low-level inflammation leading to lower immunity. One of these consequences is a weaker intestinal barrier, which reduces the function of the digestive system and can cause constipation. The microorganisms in the gut can change in the elderly. Indeed, it has been shown that different species inhabit the elderly gut compared to the one of a young adult. The use of probiotics (live bacteria that can help in the establishment of a healthy gut microorganisms) and prebiotics (food ingredients that allow changes in the composition of the gut microorganisms because of the selective digestion of products by bacteria) has been shown to have beneficial effects on the health of elderly with some diseases like irritable bowel syndrome and inflammatory bowel disease.
The aim of this study is to compare prebiotics alone, a mixture of prebiotics and probiotics, and placebo in their effectiveness at treating common diseases in an elderly population
Who can participate?
Healthy volunteers aged from 60 to 80 years
What does the study involve?
Participants will take one stick of either prebiotic alone, a mixture of prebiotic and probiotic called DefensePlus, or an inactive product every day for 28 days, in a glass of water, away from meals. At enrolment, at the end of the 28 days of taking the supplement and follow-up 28 days after the supplement has been completed, participants will be required to give a saliva sample and a fecal sample and answer questionnaires.
What are the possible benefits and risks of participating?
Participants who take the symbiotic or the prebiotic mixtures could benefit from an improvement of CID symptoms. There are no notable risks involved in taking part in this study.
Where is the study run from?
Complife Italia Srl (Italy)
When is the study starting and how long is it expected to run for?
October 2018 to May 2019
Who is funding the study?
Regione Lombardia (Italy)
Who is the main contact?
Dr. Francesco Tursi
francesco.tursi@complifegroup.com
Contact information
Scientific
COMPLIFE ITALIA Srl
Via Guido Rossa 1
GARBAGNATE MILANESE (MI)
20024
Italy
 ORCID ID |
0000-0002-0055-5925 |
|---|---|
| Phone | +39 02 99025138 |
| francesco.tursi@complifegroup.com |
Study information
| Study design | A multicentre randomized double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Clinical study to investigate the efficacy of formulations containing prebiotics and probiotics on the intestinal microbiota and on the immune system of elderly subjects |
| Study objectives | A symbiotic and a prebiotic formulation is clinically effective in terms of microbiota modulation and immune systems activation compared to a placebo |
| Ethics approval(s) | Approved 18/01/2019, the Independent Ethical Committee for Non-Pharmacological Clinical Study Trials (Via XX Septembre 30/4, Genova, Italy, 16121; a.scudieri@studinonfarmacologici.it; +39 01942790997), ref: 2018/14 |
| Health condition(s) or problem(s) studied | Healthy elderly subjects, immunosenescence |
| Intervention | 75 elderly subjects were enrolled and randomly allocated evenly in three groups using a computer-generated restricted randomization list. At enrolment, they received 28 days of the supplement and completed baseline evaluations. Group 1 participants took a stick containing the prebiotic mixture (FOS (fructooligosaccharides from sucrose), inulin (from chicory), folic acid, vitamin B12, vitamin B6, sorbitol, sucralose, aroma, silicon dioxide, maltodextrin (from corn)). Group 2 participants took a stick containing the symbiotic mixture DefensePlus (Lactobacillus acidophilus, Lactobacillus plantarum,Bifidobacterium animalis spp. Lactis, FOS (fructooligosaccharides from sucrose), inulin (from chicory), folic acid, vitamin B12, vitamin B6, sorbitol, sucralose, aroma, silicon dioxide, maltodextrin (from corn)). Group 3 participants took a stick containing a placebo (folic acid, vitamin B12, vitamin B6, sorbitol, sucralose, aroma, silicon dioxide, maltodextrin (from corn)). All participants took 1 stick a day for 28 days, in a glass of water, away from meals. All participants were asked to return to the study centers 28 days after the last intake of the supplement for follow-up evaluation. |
| Intervention type | Supplement |
| Primary outcome measure | 1. Combined immunodeficiency symptoms, measured using a questionnaire of related symptoms, on a 4 points score at baseline and 28 days 2. Fecal calprotectin levels, determined by ELISA assays on stool samples collected at baseline and 28 days 3. Fecal beta-defensin 2 levels, determined by ELISA assays on stool samples collected at baseline and 28 days 4. Salivary IgA levels, determined by ELISA assays on salivary samples collected at baseline and 28 days. 5. Total Antioxidant Capacity, determined by FRAP assays on salivary samples collected at baseline and 28 days 6. Gut microbiota composition, determined through fecal microbiological analyses using V3-V4 16S NGS sequencing on DNA from stool samples collected at baseline and 28 days 7. Gut colonization, determined through fecal microbiological analysis using species-specific qPCR on DNA from stool samples collected at baseline and 28 days |
| Secondary outcome measures | 1. Maintenance of combined immunodeficiency symptoms one month after treatment, determined using the questionnaire of related symptoms, based on a 4 points score at baseline, 28 and 56 days 2. Maintenance of fecal calprotectin levels one month after treatment, determined by ELISA assays on stool samples collected at baseline, 28 and 56 days 3. Maintenance of fecal beta-defensin 2 levels one month after treatment, determined by ELISA assays on stool samples collected at baseline, 28 and 56 days 4. Maintenance of salivary IgA levels one month after treatment, determined by ELISA assays on salivary samples collected at baseline, 28 and 56 days 5. Maintenance of total antioxidant capacity one month after treatment, determined by FRAP assays on salivary samples collected at baseline, 28 and 56 days 6. Maintenance of gut microbiota composition one month after treatment, determined through fecal microbiological analyses using V3-V4 16S NGS sequencing on DNA from stool samples collected at baseline, 28 and 56 days |
| Overall study start date | 02/10/2018 |
| Completion date | 13/05/2019 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 75 |
| Key inclusion criteria | 1. Aged from 60 to 80 years on the day of inclusion 2. Ability to comply with all the trial procedures 3. Received an influenza vaccine more than 12 months prior to enrolment 4. Body Mass Index (BMI) between 18.5 and 24.99 5. Willingness to not vary the daily diet, fluid intake, and exercise routine during the trial period 6. Willingness to follow the proposed alimentary supplement for the trial period 7. Willingness to use only the supplement being tested during the trial period 8. Willingness to not use products likely to interfere with the product to be tested 9. Informed consent is given |
| Key exclusion criteria | 1. Contraindications to the influenza vaccine 2. Immune system modulation treatment received within 4 weeks of the trial period 3. Immunosuppressant therapy lasting more than 2 weeks or stopped less than 3 months prior to the trial period 4. Influenza vaccination within one year of the trial period 5. Current antibiotic treatment 6. Known history of a chronic medical condition such as congenital heart disease, liver or kidney disease, or immune deficiency 7. Treatment with probiotics within 6 months of the trial period 8. Severe concurrent disease 9. Drug abuse 10. Alcohol abuse 11. Use of fiber products within 6 weeks of the trial period 12. Normal dietary intake exceptionally high in plant-based, high-fiber foods (fruits, vegetables, beans, whole grains, fortified foods), including those following a strict vegetarian diet 13. Dietary intake of probiotics 14. Pre-existing hypersensitivity to components contained in the probiotic 15. Any condition that the principal investigator deems inappropriate for participation 16. Adult protected by the law (under guardianship, or hospitalized in a public or private institution, for a reason other than the research, or incarcerated). 17. Subjects who have been recently involved in any other similar study |
| Date of first enrolment | 20/02/2019 |
| Date of final enrolment | 18/03/2019 |
Locations
Countries of recruitment
- Italy
Study participating centres
San Martino Siccomario (PV)
27028
Italy
Milano
20146
Italy
Biella
13900
Italy
Sponsor information
Industry
Via Guido Rossa 1
Garbagnate Milanese
20024
Italy
| Phone | + 39 2 99025138 |
|---|---|
| info@complifegroup.com | |
| Website | complifegroup.com |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Lombardy Region, Region of Lombardy
- Location
- Italy
Results and Publications
| Intention to publish date | 01/06/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Data will be published in relevant international peer-reviewed journals. |
| IPD sharing plan | The datasets generated and/or analyzed during the current study during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 20/06/2022 | 28/03/2023 | Yes | No |
Editorial Notes
28/03/2023: Publication reference added.
14/06/2021: The intention to publish date was changed from 31/03/2020 to 01/06/2021.
