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

NCT06619067 | Completed DMC

• 1 other identifier: 2024/19
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Gut; Microbiota Balance

Keywords

Probiotics; Gut health; Microbiota

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (5)

• Intestinal microbiota composition

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

• SCFA determination

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

• Changes in quality of life.

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

• Changes in intestinal functionality

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

• Changes on gastrointestinal symptoms

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

Study Arms (2)

Treated group

ACTIVE COMPARATOR

Dietary supplement: PROBAFLOR 20 Billion CFU/dose, serving size = 1 capsule/day

Dietary Supplement: PROBAFLOR

Placebo group

PLACEBO COMPARATOR

Placebo Placebo product, serving size = 1 capsule/day

Other: Placebo

Interventions

PROBAFLOR DIETARY_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.

Treated group

Placebo OTHER

Placebo

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Synbiotec Srl: lead

Study Sites (1)

Scuola di Bioscienze e Medicina Veterinaria, Università di Camerino

Camerino, Macerata, 62032, Italy

Location

Related Publications (9)

• 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.

  PMID: 9481153 BACKGROUND

• 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.

  PMID: 9299672 BACKGROUND

• 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.

  PMID: 7749697 BACKGROUND

• 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.

  PMID: 27500859 BACKGROUND

• 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.

  PMID: 19519443 BACKGROUND

• 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.

  PMID: 14747689 BACKGROUND

• 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.

  PMID: 12927512 BACKGROUND

• 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.

  PMID: 35927504 BACKGROUND

• 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.

  PMID: 21899798 BACKGROUND

Study Officials

• Maria Cristina Verdenelli, PhD

  Synbiotec Srl

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: July 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: March 31, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-01

Locations

IT (1)