Condition category
Haematological Disorders
Date applied
31/01/2020
Date assigned
07/02/2020
Last edited
06/02/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Francesco Tursi

ORCID ID

http://orcid.org/0000-0002-0055-5925

Contact details

COMPLIFE ITALIA Srl
Via Guido Rossa 1
GARBAGNATE MILANESE (MI)
20024
Italy
+39 02 99025138
francesco.tursi@complifegroup.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

N/A

Study information

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

Acronym

Study hypothesis

A symbiotic and a prebiotic formulation is clinically effective in terms of microbiota modulation and immune systems activation compared to a placebo

Ethics approval

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

Study design

A multicentre randomized double-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

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

Phase

Drug names

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 trial start date

02/10/2018

Overall trial end date

13/05/2019

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Healthy volunteer

Age group

Senior

Gender

Both

Target number of participants

75

Participant 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

Recruitment start date

20/02/2019

Recruitment end date

18/03/2019

Locations

Countries of recruitment

Italy

Trial participating centre

Complife Italia Srl
Via Mons. Angelini, 21
San Martino Siccomario (PV)
27028
Italy

Trial participating centre

Complife Italia Srl
Piazzale Siena, 11
Milano
20146
Italy

Trial participating centre

Complife Italia Srl
Corso San Maurizio, 25
Biella
13900
Italy

Sponsor information

Organisation

Complife Italia Srl

Sponsor details

Via Guido Rossa 1
Garbagnate Milanese
20024
Italy
+ 39 2 99025138
info@complifegroup.com

Sponsor type

Industry

Website

complifegroup.com

Funders

Funder type

Government

Funder name

Regione Lombardia

Alternative name(s)

Lombardy Region, Region of Lombardy

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Italy

Results and Publications

Publication and dissemination plan

Data will be published in relevant international peer-reviewed journals.

IPD Sharing statement:
The datasets generated and/or analyzed during the current study during this study will be included in the subsequent results publication

Intention to publish date

31/03/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes