Ulcerative Colitis in RemissionProZ-UCNCT06642883
Evaluation of ProLife 10 FORTE on Gut Microbiota Composition in UC Patients
A study testing Prolife in people with Ulcerative Colitis in Remission, run by University of Padova at 1 site in Italy.
Trial summary
This clinical trial aims to learn if the probiotic Prolife 10 Forte could improve the Gut Microbiota composition of Ulcerative colitis patients during the remission phase. The main questions it seeks to answer are: Does Prolife 10 Forte improve the microbiota composition in patients with Ulcerative colitis? Is it… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis in Remission
- What is being tested?
- Prolife
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 15 May 2024to 15 Jun 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of UC confirmed by clinical, endoscopic, and histopathological evidence. Disease in remission phase confirmed by clinical, endoscopic, and histopathological evidence.
- Age between 18 and 75 years old.
- Ability of the subject to participate fully in all aspects of this clinical trial.
Who cannot join
- Patients with active UC are determined by clinical, endoscopic, and histopathological evidence.
- Known diagnosis of CD, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis or microscopic colitis.
- Positive stool culture for active C. difficile.
- Pregnant women.
- Allergy to soy or fructose (contained in Prolife 10 FORTE)
- Patients under antibiotic and/or probiotic treatment within 10 days before visit1.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Edoardo Vincenzo Savarino
Padua, Padua, 35128
Edoardo V. Savarino, +39.049.8217749, edoardo.savarino@unipd.it
Sonia Facchin, sonia.facchin@unipd.it
About this study
Official title: Evaluation of the Effects of 10-strain Probiotic (ProLife 10 FORTE) on Gut Microbiota Composition in Patients Presenting with Ulcerative Colitis During the Remission Phase
This clinical trial aims to learn if the probiotic Prolife 10 Forte could improve the Gut Microbiota composition of Ulcerative colitis patients during the remission phase. The main questions it seeks to answer are:
- Does Prolife 10 Forte improve the microbiota composition in patients with Ulcerative colitis?
- Is it possible to highlight the variation in microbial pathways?
- What clinical parameters vary and are associated with changes in the gut microbiota? Researchers will compare Prolife 10 Forte to a placebo (a look-alike substance containing no drug) to see if the probiotics improve microbiota.
Read more
Participants will:
- Take 1 vial/day of Prolife 10 Forte /Placebo for 60 days.
- Visit the clinic two times for checkups, Questionaire and tests
Read the detailed description
Ulcerative colitis (UC) is a chronic, idiopathic inflammatory disease that affects the colon. It is characterized by relapsing and remitting mucosal inflammation, and it can either affect only the rectum or extend along the colon. It is known that the gut microbiota also affects UC pathology. When its composition is altered, some microbiota-dependent mechanisms may be lost, resulting in an unbalanced relationship with the host: this condition is known with the name dysbiosis.Differences in gut microbiome composition and function have been associated with a variety of chronic diseases ranging from gastrointestinal inflammatory and metabolic conditions to neurological, cardiovascular, and respiratory illnesses.
Some trials have already been performed to understand if probiotics can also help in the UC management. For what concerns the human population, the literature contains many studies performed to evaluate the effect of different products on active or remitting disease. Most of the available literature is related to the use of a multiple-strain probiotic demonstrated that probiotic strains led to remission in some UC patients, with significant improvement in rectal bleeding and stool frequency, mucosal appearance, and clinical evaluation.
Prolife 10 FORTE has already been tested by our team to evaluate its composition and its ability to reach the gut, with positive results (unpublished data). Our team has performed the Shotgun analysis of the Prolife 10 FORTE that has confirmed the presence of all 10 strains of probiotics. The metabolic parameters of the product were also analyzed, highlighting a potential enrichment in the production of SCFA and in the fermentative pathways' degradation of starches, the biosynthesis of deoxyribonucleotides, and vitamins B2, B9, K, etc...
Thus, considering these positive premises, we now want to verify if Prolife 10 FORTE could improve the Gut Microbiota composition of UC patients during the remission phase.
- Conditions
- Ulcerative Colitis in Remission
- Being tested
- Prolife, Placebo
- Keywords
- Microbiota, Probiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProlifeDietary supplement
randomized in a 1:1 ratio to treatment :1 vial/day for 60 days.
PlaceboDietary supplement
Placebo: 1 vial/day for 60 days.
| Study group | Role | What they receive |
|---|---|---|
| Prolife 10 Forte | Active comparator | Treatment: 1 dose/die (contains 10 ml with: in particular, 7 strains of Lactobacillus (L. casei R215, L. plantarum Lp-115, L. helveticus R0052, L. acidophilus La-14, L. gasseri Lg-36, L. brevis Lbr-35, L. rhamnosus HN001), 2 strains of Bifidobacteria (B. lactis Bl-04 and HN019) and Bacillus coagulans BC4. In addition, it contains 10 mg of glucoligosaccharide and a pool of Vitamin B (B1, B2, B6, B12). Receives: Dietary Supplement: Prolife |
| Placebo | Placebo comparator | Treatment 1dose/die ( All additional components except probiotics and vitamins) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the gut microbiota composition variation (microbiota test)
Collection of fecal samples to assess the fecal microbiota composition ( rRNA16S) The 16S rRNA gene is a bacterial ribosomal gene and a part of the 30S subunit used in the identification, characterization, and classification of various bacteria. Samples were normalized, pooled, and run on Illumina MiSeq, to evaluate the composition of gut microbiota in terms of bacterial diversity ( alfa and beta) and abundance and any variability associated with the treatment.
Measured: From enrollment to the end of treatment 8 weeks
Secondary outcomes (1)
Evaluation of gut microbiota pathways variation ( Picrust analysis)
PICRUSt (Phylogenetic Investigation of Communities by Reconstruction of Unobserved States) is a bioinformatics tool used to predict the genetic functions of microbial communities based on DNA sequencing data.
Measured: The microbiota analysis period, after 16S analysis: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start15 May 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis in RemissionStudies 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
- Parallel groups
- Model description
- This is a double-blind, placebo-controlled, randomized trial in which the enrolled subjects will be included in one year. After the written informed consent collection, subjects will be randomized in a 1:1 ratio to the Group 1 or Group 2: * Group 1 will take Treatment A: 1 vial/day of PROLIFE 10 FORTE for 60 days. * Group 2 will take the Treatment B: 1 vial/day of placebo for 60 days. We will enroll 70 UC patients in the remission phase, both males and females, with a diagnosis of Ulcerative Colitis for at least three months. The therapy undertaken could not be changed nor stopped during the probiotic administration
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Savarino Edoardo Vincenzo, University of Padova
- Investigators
- Edoardo V Savarino, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642883
- Sponsor's protocol ID
- 5890/AO/23
- Acronym
- ProZ-UC
- Status last verified
- Oct 2024
- First submitted
- 9 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of 10-strain Probiotic (ProLife 10 FORTE) on Gut Microbiota Composition in Patients Presenting with Ulcerative Colitis During the Remission Phase
- ClinicalTrials.gov ID
- NCT06642883
- Acronym / sponsor ID
- ProZ-UC / 5890/AO/23
- Conditions
- Ulcerative Colitis in Remission
- Keywords
- Microbiota, Probiotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 15 Oct 2024 (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.
This clinical trial aims to learn if the probiotic Prolife 10 Forte could improve the Gut Microbiota composition of Ulcerative colitis patients during the remission phase. The main questions it seeks to answer are:
- Does Prolife 10 Forte improve the microbiota composition in patients with Ulcerative colitis?
- Is it possible to highlight the variation in microbial pathways?
- What clinical parameters vary and are associated with changes in the gut microbiota? Researchers will compare Prolife 10 Forte to a placebo (a look-alike substance containing no drug) to see if the probiotics improve microbiota.
Participants will:
- Take 1 vial/day of Prolife 10 Forte /Placebo for 60 days.
- Visit the clinic two times for checkups, Questionaire and tests
Detailed description
Ulcerative colitis (UC) is a chronic, idiopathic inflammatory disease that affects the colon. It is characterized by relapsing and remitting mucosal inflammation, and it can either affect only the rectum or extend along the colon. It is known that the gut microbiota also affects UC pathology. When its composition is altered, some microbiota-dependent mechanisms may be lost, resulting in an unbalanced relationship with the host: this condition is known with the name dysbiosis.Differences in gut microbiome composition and function have been associated with a variety of chronic diseases ranging from gastrointestinal inflammatory and metabolic conditions to neurological, cardiovascular, and respiratory illnesses.
Some trials have already been performed to understand if probiotics can also help in the UC management. For what concerns the human population, the literature contains many studies performed to evaluate the effect of different products on active or remitting disease. Most of the available literature is related to the use of a multiple-strain probiotic demonstrated that probiotic strains led to remission in some UC patients, with significant improvement in rectal bleeding and stool frequency, mucosal appearance, and clinical evaluation.
Prolife 10 FORTE has already been tested by our team to evaluate its composition and its ability to reach the gut, with positive results (unpublished data). Our team has performed the Shotgun analysis of the Prolife 10 FORTE that has confirmed the presence of all 10 strains of probiotics. The metabolic parameters of the product were also analyzed, highlighting a potential enrichment in the production of SCFA and in the fermentative pathways' degradation of starches, the biosynthesis of deoxyribonucleotides, and vitamins B2, B9, K, etc...
Thus, considering these positive premises, we now want to verify if Prolife 10 FORTE could improve the Gut Microbiota composition of UC patients during the remission phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a double-blind, placebo-controlled, randomized trial in which the enrolled subjects will be included in one year. After the written informed consent collection, subjects will be randomized in a 1:1 ratio to the Group 1 or Group 2: * Group 1 will take Treatment A: 1 vial/day of PROLIFE 10 FORTE for 60 days. * Group 2 will take the Treatment B: 1 vial/day of placebo for 60 days. We will enroll 70 UC patients in the remission phase, both males and females, with a diagnosis of Ulcerative Colitis for at least three months. The therapy undertaken could not be changed nor stopped during the probiotic administration
| Arm | Type | Receives |
|---|---|---|
| Prolife 10 Forte | Active comparator | Dietary Supplement: ProlifeTreatment: 1 dose/die (contains 10 ml with: in particular, 7 strains of Lactobacillus (L. casei R215, L. plantarum Lp-115, L. helveticus R0052, L. acidophilus La-14, L. gasseri Lg-36, L. brevis Lbr-35, L. rhamnosus HN001), 2 strains of Bifidobacteria (B. lactis Bl-04 and HN019) and Bacillus coagulans BC4. In addition, it contains 10 mg of glucoligosaccharide and a pool of Vitamin B (B1, B2, B6, B12). |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboTreatment 1dose/die ( All additional components except probiotics and vitamins) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of UC confirmed by clinical, endoscopic, and histopathological evidence. Disease in remission phase confirmed by clinical, endoscopic, and histopathological evidence.
- Age between 18 and 75 years old.
- Ability of the subject to participate fully in all aspects of this clinical trial.
Key exclusion criteria (6 listed)
- Patients with active UC are determined by clinical, endoscopic, and histopathological evidence.
- Known diagnosis of CD, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis or microscopic colitis.
- Positive stool culture for active C. difficile.
- Pregnant women.
- Allergy to soy or fructose (contained in Prolife 10 FORTE)
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 |
|---|---|---|
| Proliferandomized in a 1:1 ratio to treatment :1 vial/day for 60 days. | Dietary supplement | Prolife 10 Forte |
| PlaceboPlacebo: 1 vial/day for 60 days. | Dietary supplement | Placebo |
Primary outcome
Evaluation of the gut microbiota composition variation (microbiota test)
Time frame: From enrollment to the end of treatment 8 weeks
Collection of fecal samples to assess the fecal microbiota composition ( rRNA16S) The 16S rRNA gene is a bacterial ribosomal gene and a part of the 30S subunit used in the identification, characterization, and classification of various bacteria. Samples were normalized, pooled, and run on Illumina MiSeq, to evaluate the composition of gut microbiota in terms of bacterial diversity ( alfa and beta) and abundance and any variability associated with the treatment.
1 secondary outcome
Evaluation of gut microbiota pathways variation ( Picrust analysis)
Time frame: The microbiota analysis period, after 16S analysis: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- 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.
Edoardo V Savarino principal investigator
University of Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolife in people with Ulcerative Colitis in Remission, run by University of Padova 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edoardo V. Savarino, Prof.MD; PhD (0498218720 ext. 0039, edoardo.savarino@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the gut microbiota composition variation (microbiota test) (time frame: From enrollment to the end of treatment 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2024.