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AzTrials

GutPROBAFLORNCT06619067

Efficacy Study of the Probiotic Food Supplement PROBAFLOR for Maintaining Intestinal Well-being

A study testing PROBAFLOR in people with Gut and Microbiota Balance, run by Synbiotec Srl at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

It is now known that intestinal health has a strong influence on the entire body. Recent research advances have demonstrated the involvement of the intestinal microbiota in the well-being of the intestine. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Gut, Microbiota Balance
What is being tested?
PROBAFLOR
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteItaly
Study dates
1 Jul 2024to 31 Mar 2025
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • men and women aged between 18 and 65;
  • healthy based on medical history;
  • commitment to comply with all firm procedures;
  • commitment to refrain from using any home remedies to control gastrointestinal problems, particularly if live bacteria are involved;
  • signature of informed consent.

Who cannot join

  • use of probiotics continuously, in the two months prior to enrollment;
  • use of antibiotics in the month before enrollment;
  • chemotherapy treatments;
  • diagnosis of respiratory, hepatic and/or renal failure;
  • Clinically significant diseases of the gastrointestinal tract (examples include, but are not limited to, celiac disease, gluten intolerance/sensitivity, inflammatory bowel disease);
  • Women who are pregnant, breastfeeding or planning to become pregnant during the study;
  • Allergy or sensitivity to the active or inactive ingredients of the investigational product.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Scuola di Bioscienze e Medicina Veterinaria, Università di Camerino

    Camerino, Macerata, 62032

Other trials in Italy

About this study

Official title: Efficacy Study of the Probiotic Food Supplement PROBAFLOR for Maintaining Intestinal Well-being: Single-centre, Controlled, Randomized, Parallel Group, Double-blind Clinical Study

It is now known that intestinal health has a strong influence on the entire body. Recent research advances have demonstrated the involvement of the intestinal microbiota in the well-being of the intestine. Preventive medicine is increasingly perceived as important in medical and economic terms, particularly in the field of gastroenterology. An innovative approach to support gut health is based on the use of modulators of the intestinal microbiome or gastrointestinal barrier, such as probiotics or prebiotics. The rationale for this study is therefore based on the hypothesis that the combination of 11 probiotic strains, conveyed through the PROBAFLOR food supplement, can play a positive role in maintaining normal intestinal function, bringing benefits to the subject who takes this supplement.

Read the detailed description

This is a randomized, double-blind, placebo-controlled intervention study with a duration of 3 months of intervention + 1 month of follow-up, on biological samples. Eligible participants will be randomized and receive either the probioic or placebo supplement to consume daily for 3 months. Three check-in visits will occur, one at the screening, the second one afetr the 3-months intervention and the final one after 1 month of followup. Participants will be expected to complete a daily study diary documenting their investigational product use/adverse events and a daily bowel habits diary documenting each bowel movement. Stool samples, and questionnaires will be completed for study outcome analysis.

Being tested
PROBAFLOR, Placebo
Keywords
Probiotics, Gut health, Microbiota

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PROBAFLORDietary supplement

    PROBAFLOR is a food supplement made up of 11 bacterial strains and inulin. The bacterial strains present are: Bifidobacterium lactis BLC1, Lactococcus lactis LL82, Lactobacillus plantarum 14D, Lactobacillus acidophilus LA1, Streptococcus thermophilus Z57, Bifidobacterium longum SP54, Lactobacillus rhamnosus SP1, Lactobacillus bulgaricus LB2, Bifidobacterium bifidum SP9,Lactobacillus salivarius SP2, Lactobacillus casei BGP93.

  • PlaceboOther

    Placebo

Study groups in NCT06619067
Study groupRoleWhat they receive
Treated groupActive comparatorDietary supplement: PROBAFLOR 20 Billion CFU/dose, serving size = 1 capsule/day
Receives: Dietary Supplement: PROBAFLOR
Placebo groupPlacebo comparatorPlacebo Placebo product, serving size = 1 capsule/day
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. maintenance and/or improvement of intestinal health and health-related quality of life (through the GIQLI questionnaire)

    Measured: Baseline, After 3 months of intervention, at follow-up (one month after the end of administration

Secondary outcomes (5)

  1. Intestinal microbiota composition

    Metagenomic analysis on faecal samples

    Measured: Baseline, After 3 months of intervention, at follow-up (one month after the end of administration

  2. SCFA determination

    Gas chromatographic analysis of fecal water

    Measured: Baseline, After 3 months of intervention, at follow-up (one month after the end of administration

  3. Changes in quality of life.

    Assessed by PGWBI (The Psychological General Well-Being Index)

    Measured: Baseline, After 3 months of intervention, at follow-up (one month after the end of administration

  4. Changes in intestinal functionality

    Assessed in accordance with the Bristol Stool Form Scale

    Measured: Baseline, After 3 months of intervention, at follow-up (one month after the end of administration

  5. Changes on gastrointestinal symptoms

    Assessed by the GSRS (Gastrointestinal Symptom Rating Scale)

    Measured: Baseline, After 3 months of intervention, at follow-up (one month after the end of administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2024
  2. Study start1 Jul 2024
  3. Primary completion31 Jan 2025
  4. Study completion31 Mar 2025

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06619067
Sponsor's protocol ID
2024/19
Acronym
PROBAFLOR
Status last verified
Jan 2025
First submitted
26 Sep 2024
Last updated
2 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Revicki DA, Wood M, Wiklund I, Crawley J. Reliability and validity of the Gastrointestinal Symptom Rating Scale in patients with gastroesophageal reflux disease. Qual Life Res. 1998 Jan;7(1):75-83. doi: 10.1023/a:1008841022998.

    PubMed 9481153

  • Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997 Sep;32(9):920-4. doi: 10.3109/00365529709011203.

    PubMed 9299672

  • Eypasch E, Williams JI, Wood-Dauphinee S, Ure BM, Schmulling C, Neugebauer E, Troidl H. Gastrointestinal Quality of Life Index: development, validation and application of a new instrument. Br J Surg. 1995 Feb;82(2):216-22. doi: 10.1002/bjs.1800820229.

    PubMed 7749697

  • Sanchez B, Delgado S, Blanco-Miguez A, Lourenco A, Gueimonde M, Margolles A. Probiotics, gut microbiota, and their influence on host health and disease. Mol Nutr Food Res. 2017 Jan;61(1). doi: 10.1002/mnfr.201600240. Epub 2016 Oct 10.

    PubMed 27500859

  • Possemiers S, Grootaert C, Vermeiren J, Gross G, Marzorati M, Verstraete W, Van de Wiele T. The intestinal environment in health and disease - recent insights on the potential of intestinal bacteria to influence human health. Curr Pharm Des. 2009;15(18):2051-65. doi: 10.2174/138161209788489159.

    PubMed 19519443

  • Mai V, Morris JG Jr. Colonic bacterial flora: changing understandings in the molecular age. J Nutr. 2004 Feb;134(2):459-64. doi: 10.1093/jn/134.2.459.

    PubMed 14747689

  • Tuohy KM, Probert HM, Smejkal CW, Gibson GR. Using probiotics and prebiotics to improve gut health. Drug Discov Today. 2003 Aug 1;8(15):692-700. doi: 10.1016/s1359-6446(03)02746-6.

    PubMed 12927512

  • Sola KF, Vladimir-Knezevic S, Hrabac P, Mucalo I, Saso L, Verbanac D. The effect of multistrain probiotics on functional constipation in the elderly: a randomized controlled trial. Eur J Clin Nutr. 2022 Dec;76(12):1675-1681. doi: 10.1038/s41430-022-01189-0. Epub 2022 Aug 4.

    PubMed 35927504

  • Rizzardini G, Eskesen D, Calder PC, Capetti A, Jespersen L, Clerici M. Evaluation of the immune benefits of two probiotic strains Bifidobacterium animalis ssp. lactis, BB-12(R) and Lactobacillus paracasei ssp. paracasei, L. casei 431(R) in an influenza vaccination model: a randomised, double-blind, placebo-controlled study. Br J Nutr. 2012 Mar;107(6):876-84. doi: 10.1017/S000711451100420X. Epub 2011 Sep 7.

    PubMed 21899798

Questions about this trial

What is this clinical trial studying?

A study testing PROBAFLOR in people with Gut and Microbiota Balance, run by Synbiotec Srl at 1 site in Italy.

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 7 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 2 Apr 2025. 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 Italy. 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?

maintenance and/or improvement of intestinal health and health-related quality of life (through the GIQLI questionnaire) (time frame: Baseline, After 3 months of intervention, at follow-up (one month after the end of administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06619067, which also lists 9 linked publications.

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 2 Apr 2025.

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