DisbiosisNCT03234452
Evaluation of the Beneficial Effects of a Probiotic Product in Healthy Adult Subjects.
A study testing Lactoflorene plus in people with Disbiosis and Abdominal Pain, run by Montefarmaco OTC SpA at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Disbiosis, Abdominal Pain, Constipation
- What is being tested?
- Lactoflorene plus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 23 Mar 2016to 18 Apr 2017
- 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Eligible subjects were healthy men and women, 20-35 years old, with a STAI scale, form Y, module 1 (state anxiety) score of ≥ 35 and ≥40, for men and women, respectively.
Who cannot join
- Most important exclusion criteria were history or diagnosis of GI disease, oral antibiotics within 30 days prior to the screening visit, and use of drugs, food or herbal supplements for digestive symptoms.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Beneficial Effects of a Probiotic Product (Lactoflorene Plus) in Healthy Adult Subjects in Particular Psychological Stress Conditions.
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.
- Conditions
- Disbiosis, Abdominal Pain, Constipation, Diarrhea, Stress
- Being tested
- Lactoflorene plus, Placebo Lactoflorene plus
- Keywords
- Lactoflorene plus, Bifidobacterium animalis subsp. lactis, BB-12®, Lactobacillus acidophilus, LA-5®, Lactobacillus paracasei subsp. paracasei, L. CASEI 431®, Inflammation, gut permeability, disbiosis, probiotic, IgA, IL10
- Medical subject headings
- Dysbiosis, Abdominal Pain, Constipation, Diarrhea, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactoflorene plusDietary supplement
2 vials with dosing cap (10 mL) a day per os
Placebo Lactoflorene plusDietary supplement
2 vials with dosing cap (10 mL) a day per os
| Study group | Role | What they receive |
|---|---|---|
| Lactoflorene plus | Experimental | 10 ml mixture of Lactobacillus acidophilus LA-5®, Bifidobacterium animalis subsp. lactis, BB-12®, Lactobacillus paracasei subsp. paracasei, L. CASEI 431® , Bacillus coagulans BC513, zinc and B-vitamins (niacin, B1, B2, B5, B6, B12 and folic acid) twice a day Receives: Dietary Supplement: Lactoflorene plus |
| Placebo Lactoflorene plus | Placebo comparator | Identical placebo mixture without probiotics, B-vitamins and zinc. The active and placebo products had similar appearance, taste and smell and were provided in identical bottles of 10 ml with identical labelling. Receives: Dietary Supplement: Placebo Lactoflorene plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
NK activity
Verify that Natural Killer activities concentration is significantly higher in the experimental Group compared to the placebo group
Measured: 45 days
Secondary outcomes (4)
IgA, IL8, TNF-Alpha, IL10
Measured: 45 days
Cortisol, alpha-amylase , chromogranin A
Measured: 45 days
microbiota composition investigation
Measured: 45 days
Gastrointestinal symptoms (abdominal pain, aerophagia, diarrhea, constipation, diarrhea/constipation alternation )
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study start23 Mar 2016
- Primary completion21 Jul 2016
- Study completion18 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DisbiosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized, double-blind, placebo-controlled, cross-over trial performed at one centre
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefarmaco OTC SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03234452
- Sponsor's protocol ID
- Lactoflorene plus
- Status last verified
- Sep 2019
- First submitted
- 26 Jul 2017
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Soldi S, Tagliacarne SC, Valsecchi C, Perna S, Rondanelli M, Ziviani L, Milleri S, Annoni A, Castellazzi A. Effect of a multistrain probiotic (Lactoflorene(R) Plus) on inflammatory parameters and microbiota composition in subjects with stress-related symptoms. Neurobiol Stress. 2018 Nov 7;10:100138. doi: 10.1016/j.ynstr.2018.11.001. eCollection 2019 Feb.
PubMed 30937345
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Beneficial Effects of a Probiotic Product (Lactoflorene Plus) in Healthy Adult Subjects in Particular Psychological Stress Conditions.
- ClinicalTrials.gov ID
- NCT03234452
- Acronym / sponsor ID
- Lactoflorene plus
- Conditions
- Disbiosis, Abdominal Pain, Constipation, Diarrhea, Stress
- Keywords
- Lactoflorene plus, Bifidobacterium animalis subsp. lactis, BB-12®, Lactobacillus acidophilus, LA-5®, Lactobacillus paracasei subsp. paracasei, L. CASEI 431®, Inflammation, gut permeability, disbiosis, probiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Montefarmaco OTC SpAIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2016 (actual)
- Primary completion
- 21 Jul 2016 (actual)
- Study completion
- 18 Apr 2017 (actual)
- First posted
- 31 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, double-blind, placebo-controlled, cross-over trial performed at one centre
| Arm | Type | Receives |
|---|---|---|
| Lactoflorene plus | Experimental | Dietary Supplement: Lactoflorene plus10 ml mixture of Lactobacillus acidophilus LA-5®, Bifidobacterium animalis subsp. lactis, BB-12®, Lactobacillus paracasei subsp. paracasei, L. CASEI 431® , Bacillus coagulans BC513, zinc and B-vitamins (niacin, B1, B2, B5, B6, B12 and folic acid) twice a day |
| Placebo Lactoflorene plus | Placebo comparator | Dietary Supplement: Placebo Lactoflorene plusIdentical placebo mixture without probiotics, B-vitamins and zinc. The active and placebo products had similar appearance, taste and smell and were provided in identical bottles of 10 ml with identical labelling. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Eligible subjects were healthy men and women, 20-35 years old, with a STAI scale, form Y, module 1 (state anxiety) score of ≥ 35 and ≥40, for men and women, respectively.
Key exclusion criteria (1 listed)
- Most important exclusion criteria were history or diagnosis of GI disease, oral antibiotics within 30 days prior to the screening visit, and use of drugs, food or herbal supplements for digestive symptoms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactoflorene plus2 vials with dosing cap (10 mL) a day per os | Dietary supplement | Lactoflorene plus |
| Placebo Lactoflorene plus2 vials with dosing cap (10 mL) a day per os | Dietary supplement | Placebo Lactoflorene plus |
Primary outcome
NK activity
Time frame: 45 days
Verify that Natural Killer activities concentration is significantly higher in the experimental Group compared to the placebo group
4 secondary outcomes
IgA, IL8, TNF-Alpha, IL10
Time frame: 45 days
Cortisol, alpha-amylase , chromogranin A
Time frame: 45 days
microbiota composition investigation
Time frame: 45 days
Gastrointestinal symptoms (abdominal pain, aerophagia, diarrhea, constipation, diarrhea/constipation alternation )
Time frame: 45 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Derived from this study: PubMed 30937345Soldi S, Tagliacarne SC, Valsecchi C, Perna S, Rondanelli M, Ziviani L, Milleri S, Annoni A, Castellazzi A. Effect of a multistrain probiotic (Lactoflorene(R) Plus) on inflammatory parameters and microbiota composition in subjects with stress-related symptoms. Neurobiol Stress. 2018 Nov 7;10:100138. doi: 10.1016/j.ynstr.2018.11.001. eCollection 2019 Feb.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactoflorene plus in people with Disbiosis and Abdominal Pain, run by Montefarmaco OTC SpA 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 1 inclusion and 1 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 9 Sep 2019. 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?
NK activity (time frame: 45 days). 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 NCT03234452, which also lists 1 linked publication.
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 9 Sep 2019; AzTrials last refreshed its copy on 8 Nov 2026.