Inflammatory Bowel Disease, Ulcerative Colitis TypeCOLIPRALNCT07751081
Evaluation of the Effects of Colipral on Microbiota Gut Composition in Patients Presenting With Ulcerative Colitis During Remission Phase and Functional Disorders
A study testing Food Supplement Colipral in film-coated tablets containing Escherichia coli 5C LMG S-33222 in people with Inflammatory Bowel Disease, Ulcerative Colitis Type and Functional Disorder of Gastrointestinal Tract, run by University of Padova at 1 site in Italy.
Trial summary
The study is a double-blind, placebo-controlled, crossover, randomised trial, in which enrolled subjects will be included for 18 months. This study aims to evaluate the effect of the Colipral as a Food Supplement prescribed according to the standard of care of patients suffering UC during remission phase and DGBI. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Inflammatory Bowel Disease, Ulcerative Colitis Type, Functional Disorder of Gastrointestinal Tract
- What is being tested?
- Food Supplement Colipral in film-coated tablets containing Escherichia coli 5C LMG S-33222
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 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 for at least 6 months
- Diagnosis of disorders of gut-brain interaction (DGBI): IBS-D, IBS-M, bloating, and abdominal pain
- Male/female
- Age in the range 18-70 years
- Subjects capable of conforming to the study protocol
- Subjects who have given their free and informed consent
Who cannot join
- History of gastrointestinal disorders or gastrointestinal surgery interfering with gastrointestinal function
- Subjects with untreated food intolerance, i.e. remaining symptomatic despite the withdrawal of the suspected food
- Currently following a restrictive diet (for example low FODMAPs diet or vegan diet)
- Females of childbearing potential, in the absence of effective contraceptive methods
- Subjects who become unable to conform to protocol
- Recent history or suspicion of alcohol abuse or drug addiction
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- Indication for the initiation of a new drug therapy during the study
- History of current or recent antibiotic or probiotics use within the last 30 days
- Subjects who are treated with antibiotics
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Azienda Ospedale - Univeristà Padova
Padova, Padova, 35128
Fabiana Zingone, +39 0498215656, fabiana.zingone@unipd.it
About this study
Official title: Evaluation of the Effects of Colipral® (E.Coli 5C LMG S-33222) on Microbiota Gut Composition in Patients Presenting With Ulcerative Colitis During Remission Phase and Functional Disorders
The study is a double-blind, placebo-controlled, crossover, randomised trial, in which enrolled subjects will be included for 18 months. This study aims to evaluate the effect of the Colipral as a Food Supplement prescribed according to the standard of care of patients suffering UC during remission phase and DGBI.
The primary objective of the study is to evaluate the variation in gut microbiota, specifically focusing on bacterial diversity and abundance, in patients with UC during the remission phase and DGBI.
The secondary objective of the study is to evaluate the clinical parameters variations (based on fecal calprotectin and IBDQ's score before and after the treatment), the severity of gastrointestinal symptoms, the quality of life, and the maintenance of the remission phase in patients with UC in remission and DGBI.
Read the detailed description
The primary endpoint will be the variation in gut microbiota analyzed through 16S rRNA gene sequencing from a fecal sample of patients presenting UC during remission phase and DGBI at three time points: T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B).
The secondary endpoint will be the assessment of the clinical parameters variation based on fecal calprotectin in patients presenting UC during remission phase and DGBI at three time points: T=0 (baseline, before treatment), T=1 (after an additional 60 days of treatment A or B), and T=3 (after 60 days of treatment A or B).
The severity of gastrointestinal symptoms and quality of life will be assessed using the IBDQ, IBS SSS, VAS, and Bristol Stool Scale questionnaires at three time points: T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B). Patients' dietary habits will be analysed using the WCRF questionnaire at the first and final visit.
- Conditions
- Inflammatory Bowel Disease, Ulcerative Colitis Type, Functional Disorder of Gastrointestinal Tract
- Being tested
- Food Supplement Colipral in film-coated tablets containing Escherichia coli 5C LMG S-33222, Placebo
- Keywords
- inflammatory bowel disease, ulcerative colitis, functional disorders, gut microbiota
- Medical subject headings
- Colitis, Ulcerative, Gastrointestinal Diseases, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food Supplement Colipral in film-coated tablets containing Escherichia coli 5C LMG S-33222Dietary supplement
2 tablets/day of Colipral (1/breakfast, and 1/dinner, before the meal) for 60 days
PlaceboOther
2 tablets/day of Placebo (1/breakfast, and 1/dinner, before the meal) for 60 days
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplement Group (Treatment A) | Active comparator | In this arm patients receive 2 tablets/day of Colipral (1/breakfast, and 1/dinner, before the meal) for 60 days Receives: Dietary Supplement: Food Supplement Colipral in film-coated tablets containing Escherichia coli 5C LMG S-33222 |
| Placebo Group (Treatment B) | Placebo comparator | In this arm patients receive 2 tablets/day of placebo (1/breakfast, and 1/dinner, before the meal) for 60 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiota gut composition
The primary endpoint will be the variation in gut microbiota analyzed through 16S rRNA gene sequencing from a fecal sample of patients presenting UC during remission phase and DGBI.
Measured: T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B).
Secondary outcomes (6)
Fecal calprotectin levels
Concentration of fecal calprotectin measured in mg/Kg as an objective marker of intestinal inflammation. Normal value is <250 mg/Kg, with higher values indicating active intestinal inflammation.
Measured: T=0 (baseline, before treatment), T=1 (after an additional 60 days of treatment A or B), and T=3 (after 60 days of treatment A or B)
Quality of life in patiets with inflammatory bowel disease
Quality of life will be assessed using the IBDQ (Inflammatory Bowel Disease Questionnaire). This is a 32-item questionnaire that evaluates symptoms and well-being over the prior two weeks using a 7-point scale from 1 (worst) to 7 (best). Total scores range from 32 to 224, with higher scores indicating a better quality of life.
Measured: T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B).
Dietary habits
Patients' dietary habits will be analysed using the WCRF questionnaire, which assesses dietary habits, particularly the questions focus on common eating patterns.
Measured: T=0 (baseline, before treatment) and T=3 (after taking both treatment A and treatment B)
Gastrointestinal symptom severity in patients with Irritable Bowel Syndrome
The severity of gastrointestinal symptoms will be assessed using IBS Symptom Severity Scale, which measures the intensity and frequency of abdominal pain, severity of abdominal distention, and dissatisfaction with bowel habits. Scores on the IBS-SSS range from 0 to 500 with higher scores indicating more severe symptoms.
Measured: T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B).
Severity of gastrointestinal symptoms
Severity of gastrointestinal symptoms will be assessed using the Visual Analog Scale (VAS) that measure for acute and chronic pain by making a handwritten mark on a 10-cm line (0 = "No Pain" to 100 = "Worst Imaginable Pain"). The patient marks a point on the line corresponding to their symptom intensity.
Measured: T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B).
Severity of gastrointestinal symptoms
Severity of gastrointestinal symptoms will be assessed using Bristol Stool Scale. This is a chart that rate the stools into seven categories based on form and consistency. Types 1,2 (constipation), types 3,4 (normal bowel function), types 5,6,7(diarrhea).
Measured: T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease, Ulcerative Colitis TypeStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZINGONE FABIANA, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751081
- Sponsor's protocol ID
- 6576/AO/26
- Acronym
- COLIPRAL
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in publications will be made available to qualified researchers upon reasonable request to the Principal Investigator, subject to approval of the study Sponsor and to a signed data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Colipral® (E.Coli 5C LMG S-33222) on Microbiota Gut Composition in Patients Presenting With Ulcerative Colitis During Remission Phase and Functional Disorders
- ClinicalTrials.gov ID
- NCT07751081
- Acronym / sponsor ID
- COLIPRAL / 6576/AO/26
- Conditions
- Inflammatory Bowel Disease, Ulcerative Colitis Type, Functional Disorder of Gastrointestinal Tract
- Keywords
- inflammatory bowel disease, ulcerative colitis, functional disorders, gut microbiota
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 7 Aug 2026 (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.
The study is a double-blind, placebo-controlled, crossover, randomised trial, in which enrolled subjects will be included for 18 months. This study aims to evaluate the effect of the Colipral as a Food Supplement prescribed according to the standard of care of patients suffering UC during remission phase and DGBI.
The primary objective of the study is to evaluate the variation in gut microbiota, specifically focusing on bacterial diversity and abundance, in patients with UC during the remission phase and DGBI.
The secondary objective of the study is to evaluate the clinical parameters variations (based on fecal calprotectin and IBDQ's score before and after the treatment), the severity of gastrointestinal symptoms, the quality of life, and the maintenance of the remission phase in patients with UC in remission and DGBI.
Detailed description
The primary endpoint will be the variation in gut microbiota analyzed through 16S rRNA gene sequencing from a fecal sample of patients presenting UC during remission phase and DGBI at three time points: T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B).
The secondary endpoint will be the assessment of the clinical parameters variation based on fecal calprotectin in patients presenting UC during remission phase and DGBI at three time points: T=0 (baseline, before treatment), T=1 (after an additional 60 days of treatment A or B), and T=3 (after 60 days of treatment A or B).
The severity of gastrointestinal symptoms and quality of life will be assessed using the IBDQ, IBS SSS, VAS, and Bristol Stool Scale questionnaires at three time points: T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B). Patients' dietary habits will be analysed using the WCRF questionnaire at the first and final visit.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement Group (Treatment A) | Active comparator | Dietary Supplement: Food Supplement Colipral in film-coated tablets containing Escherichia coli 5C LMG S-33222In this arm patients receive 2 tablets/day of Colipral (1/breakfast, and 1/dinner, before the meal) for 60 days |
| Placebo Group (Treatment B) | Placebo comparator | Other: PlaceboIn this arm patients receive 2 tablets/day of placebo (1/breakfast, and 1/dinner, before the meal) for 60 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of UC confirmed by clinical, endoscopic and histopathological evidence.
- Disease in remission phase confirmed by clinical, endoscopic and histopathological evidence for at least 6 months
- Diagnosis of disorders of gut-brain interaction (DGBI): IBS-D, IBS-M, bloating, and abdominal pain
- Male/female
- Age in the range 18-70 years
Key exclusion criteria (9 listed)
- History of gastrointestinal disorders or gastrointestinal surgery interfering with gastrointestinal function
- Subjects with untreated food intolerance, i.e. remaining symptomatic despite the withdrawal of the suspected food
- Currently following a restrictive diet (for example low FODMAPs diet or vegan diet)
- Females of childbearing potential, in the absence of effective contraceptive methods
- Subjects who become unable to conform to protocol
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 |
|---|---|---|
| Food Supplement Colipral in film-coated tablets containing Escherichia coli 5C LMG S-332222 tablets/day of Colipral (1/breakfast, and 1/dinner, before the meal) for 60 days | Dietary supplement | Dietary Supplement Group (Treatment A) |
| Placebo2 tablets/day of Placebo (1/breakfast, and 1/dinner, before the meal) for 60 days | Other | Placebo Group (Treatment B) |
Primary outcome
Microbiota gut composition
Time frame: T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B).
The primary endpoint will be the variation in gut microbiota analyzed through 16S rRNA gene sequencing from a fecal sample of patients presenting UC during remission phase and DGBI.
6 secondary outcomes
Fecal calprotectin levels
Time frame: T=0 (baseline, before treatment), T=1 (after an additional 60 days of treatment A or B), and T=3 (after 60 days of treatment A or B)
Quality of life in patiets with inflammatory bowel disease
Time frame: T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B).
Dietary habits
Time frame: T=0 (baseline, before treatment) and T=3 (after taking both treatment A and treatment B)
Gastrointestinal symptom severity in patients with Irritable Bowel Syndrome
Time frame: T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B).
Severity of gastrointestinal symptoms
Time frame: T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B).
Severity of gastrointestinal symptoms
Time frame: T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in publications will be made available to qualified researchers upon reasonable request to the Principal Investigator, subject to approval of the study Sponsor and to a signed data access agreement.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Supplement Colipral in film-coated tablets containing Escherichia coli 5C LMG S-33222 in people with Inflammatory Bowel Disease, Ulcerative Colitis Type and Functional Disorder of Gastrointestinal Tract, 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 7 inclusion and 9 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: opening soon, as of the sponsor's last update on 7 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiota gut composition (time frame: T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B).). 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 7 Aug 2026.