NCT03234452 is a NA clinical trial of Lactoflorene plus in Disbiosis, sponsored by Montefarmaco OTC SpA.

Who is sponsoring NCT03234452?

NCT03234452 is sponsored by Montefarmaco OTC SpA.

What drugs are being tested in NCT03234452?

Interventions in NCT03234452: Lactoflorene plus, Placebo Lactoflorene plus.

What condition does NCT03234452 study?

NCT03234452 studies Disbiosis, Abdominal Pain, Constipation, Diarrhea, Stress.

Is NCT03234452 still recruiting?

NCT03234452 is currently completed. Last updated 9 September 2019.

Last reviewed 2019-09-09 · How we verify

NCT03234452

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluation of the Beneficial Effects of a Probiotic Product in Healthy Adult Subjects.

Completed NA Last updated 9 September 2019

What this trial tests

NA trial testing Lactoflorene plus in Disbiosis in 50 participants. Completed in 18 April 2017.

Timeline

23 March 2016

Primary endpoint
21 July 2016

18 April 2017

Quick facts

Lead sponsor	Montefarmaco OTC SpA
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	50
Start date	23 March 2016
Primary completion	21 July 2016
Estimated completion	18 April 2017
Sites	1 location across Italy

Drugs / interventions tested

Lactoflorene plus
Placebo Lactoflorene plus

Conditions studied

Disbiosis — all drugs for Disbiosis →
Abdominal Pain — all drugs for Abdominal Pain →
Constipation — all drugs for Constipation →
Diarrhea — all drugs for Diarrhea →

Sponsor

Montefarmaco OTC SpA

Who can join

Adults 20 to 35, any sex, with Disbiosis or Abdominal Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A randomized, double-blind, placebo-controlled, cross-over trial performed at one centre in Italy to explore the ability of a multistrain probiotic mixture, to modulate markers of inflammation and intestinal barrier function and gastrointestinal symptoms in healthy volunteers with self-reported anxiety.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Effect of a multistrain probiotic (Lactoflorene<sup>®</sup> Plus) on inflammatory parameters and microbiota composition in subjects with stress-related symptoms.
Soldi S, Tagliacarne SC, Valsecchi C, Perna S, et al · · 2019 · cited 18× · PMID 30937345 · DOI 10.1016/j.ynstr.2018.11.001

Verify or expand the search:

Other recruiting trials for Disbiosis

Currently open trials in the same condition.

NCT07530575 — Limosilactobacillus Fermentum CRL 1446 - CONICET CASASCO · NA · active not recruiting

Other Montefarmaco OTC SpA trials

Trials by the same sponsor.

NCT05773963 — A Post-market Study to Evaluate the Effects of Sodium Hyaluronate Based Eye Drops in Patients Affected by Dry Eye Diseas · NA · terminated
NCT05773976 — An Interventional, Confirmative, Post Marketing Clinical Followup (PMCF) Study to Evaluate Performance and Safety of Oph · NA · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03234452 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Montefarmaco OTC SpA
Last refreshed: 9 September 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03234452.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing