IBS - Irritable Bowel SyndromePROBE2NCT03449628
L. Casei DG® in Patients With Irritable Bowel Syndrome.
A study testing L.casei DG in people with IBS - Irritable Bowel Syndrome, run by SOFAR S.p.A. at 20 sites in Italy.
Trial summary
To assess the effect of L. casei DG® (Lactobacillus paracasei CNCMI1572; Enterolactis® plus) on abdominal symptoms and gut microbiota metabolism/composition in non constipated patients with IBS (Irritable Bowel Syndrome). Patients will be randomized to receive L. casei DG® capsules, b.i.d. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- IBS - Irritable Bowel Syndrome
- What is being tested?
- L.casei DG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 20 sitesItaly
- Study dates
- 6 Nov 2017to 30 Dec 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years and ≤ 65 years
- A positive diagnosis of non constipated IBS (i.e., IBS-D and IBS-M, both males and females), according to Rome IV criteria.
- A negative outcome of colonoscopy performed within 5 years before screening if patient is at least 50 years old, or if patient meet any of the following alarm features:
- Has a documented weight loss within the past 6 months; or
- Has nocturnal symptoms; or
- Has a familiar history of colon cancer; or
Show all 9Show fewer
- Has blood mixed with their stool (excluding blood from hemorroids).
- Negative relevant additional screening or consultation whenever appropriate
- Ability to conform to the study protocol.
Who cannot join
- Patients with IBS-C or IBS-U according to Rome IV criteria
- Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant on the basis of predefined values, (i.e..liver or kidney functional levels 2-times greater than the upper reference values)
- Ascertained intestinal organic diseases, including celiac disease, food allergies or inflammatory bowel diseases (Crohn's disease, ulcerative colitis, diverticular disease, infectious colitis, ischemic colitis, microscopic colitis).
- Previous major abdominal surgery.
- Active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrolment are also acceptable).
- Untreated food intolerance such as ascertained or suspected lactose intolerance, as defined by anamnestic evaluation or, if appropriate, lactose breath test.
Show all 13Show fewer
- Use of probiotics or topical and/or systemic antibiotic therapy during the last month.
- Systematic/frequent use of contact laxatives.
- Pregnant females or females of childbearing potential in the absence of effective contraceptive methods.
- Inability to conform to protocol.
- Treatment with any investigational drug within the previous 30 days.
- Recent history or suspicion of alcohol abuse or drug addiction.
- Presence of red or white flags at the Rome IV Psychosocial Alarm Questionnaire for Functional gastrointestinal Disorders.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Italy20 sites
Gastroenterologia Universitaria Policlinico Giovanni XXIII
Bari
Azienda ULSS 1
Belluno
Azienda Ospedaliero-Universitaria S. Orsola Malpighi
Bologna, 40100
A.O. "G. Brotzu"- Ospedale San Michele
Cagliari, CA
AOU di Cagliari - Policlinico di Monserrato
Cagliari, CA
Ospedale SS. Annunziata
Chieti
Ospedale Valduce
Como, CO
ASST-FTB-Sacco
Milan, MI
Fondazione IRCCS Policlinico
Milan
Policlinico
Naples, 80100
Policlinico Federico II
Naples
Azienda Ospedaliera di Padova
Padova
Fondazione IRCCS Policlinico S. Matteo
Pavia
U.O. Gastroenterologia Universitaria
Pisa
Policlinico Universitario Campus Biomedico
Roma, 00128
A.O. San Camillo-Forlanini
Roma
Ospedale Sant'Andrea
Roma
Policlinico San Donato
San Donato Milanese, MI
A.O. Bolognini
Seriate, BG
Ospedale Sant'Andrea
Vercelli, VC
About this study
Official title: L. Casei DG® (Lactobacillus Paracasei CNCMI1572) in the Treatment of Patients With Irritable Bowel Syndrome: a Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo Controlled Study.
To assess the effect of L. casei DG® (Lactobacillus paracasei CNCMI1572; Enterolactis® plus) on abdominal symptoms and gut microbiota metabolism/composition in non constipated patients with IBS (Irritable Bowel Syndrome). Patients will be randomized to receive L. casei DG® capsules, b.i.d. for 12 weeks the a 4 weeks Follow Up period will follow.
- Conditions
- IBS - Irritable Bowel Syndrome
- Being tested
- L.casei DG, PLACEBO
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L.casei DGDietary supplement
(At least 24 billion live cells per capsule)
1 capsule, b.i.d. for 12 weeks
PLACEBODietary supplement
1 capsule, b.i.d. for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| L. casei DG® | Experimental | Interventions: Lactobacillus paracasei CNCMI1572 (At least 24 billion live cells per capsule)
1 capsule, b.i.d. for 12 weeks Receives: Dietary Supplement: L.casei DG |
| Placebo | Placebo comparator | Interventions : capsules for oral use, indistinguishable from active product.
1 capsule, b.i.d. for 12 weeks Receives: Dietary Supplement: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who have a response in pain
Patients who record on ≥ 50% of the days a reduction of ≥ 30% from their average baseline score for their worst abdominal pain.The standard 11-point numeric rating scale (from 0=none to 10=worst possible pain) will be used to measure abdominal pain.
Measured: 12 weeks
Proportion of patients who have a response in stool consistencies
Patients who record a stool-consistency score < 5 in the same days in which they record a reduction of ≥ 30% from their average baseline score for their worst abdominal pain .For abnormal defecation, stool frequency and form will be measured using the Bristol Stool Form Scale (BSFS).
Measured: 12 weeks
Secondary outcomes (16)
Evaluation of Pain relief
reduction of ≥ 30% from baseline in the score for the worst abdominal pain on ≥ 50% of days
Measured: 16 weeks
Evaluation of global symptom score
Improvement in the global symptom score: a score of 0 or 1, or an improvement ≥ 2 over the baseline score, on ≥ 50% of days
Measured: 16 weeks
Relief of IBS symptoms
Adequate relief of IBS symptoms on ≥ 50% of the past weeks (a response of "yes" on ≥50% of the weeks to the following question: "Over the past week, have you had adequate relief of your IBS symptoms?)"
Measured: 16 weeks
IBS-SSS score questionnaire (Severity Scoring System )
To assess the severity of symptoms related to Irritable Bowel Syndrome, assessed at baseline and at the end of treatment after 12 weeks (it is considered clinically significant a score reduction of at least 50 points). The questionnaire is composed by five questions wich generate a maximum score of 100 each using prompted visual analogue scales, leading to a total possible score of 500.
Measured: 16 weeks
Improvement in stool consistency
stool consistency score ≤ 5 assessed with BSFS (Bristol Stool Form Scale) BSFS evaluates stool form and consistency (score from 1=dry stool to 7=liquid stoo. The ideal stool is generally 3 or 4)
Measured: 16 weeks
Satisfaction with treatment
Overall satisfaction with treatment assessed by VAS scale (Visual Analogue Scale)
Measured: 16 weeks
Quality of life
Quality of life assessment by validated Short-Form 12 Items Health Survey (SF-12) on a scale of 0 to 100
Measured: 16 weeks
Intake of rescue medication
type and frequencies of rescue medication
Measured: 16 weeks
gut microbiota composition
Evaluation of changes in the gut microbiota composition and the relative abundance of bacterial OTUs (Operational Taxonomic Unit).
Measured: 16 weeks
Short Chain Fatty Acids (SCFA)
Evaluation of Short Chain Fatty Acids levels in fecal samples
Measured: 16 weeks
Free Aminoacids
Evaluation of Free aminoacids levels in fecal samples
Measured: 16 weeks
Biogenic Amines
Evaluation of biogenic amines levels in fecal samples
Measured: 16 weeks
Gut permeability for zonulin
evaluation of serum levels of zonulin
Measured: 16 weeks
Gut permeability for citrulline
evaluation of serum levels of citrulline
Measured: 16 weeks
Gut permeability for PV-1 (Plasmalemma vesicle-associated) protein
evaluation of serum levels of PV-1 (Plasmalemma vesicle-associated) protein
Measured: 16 weeks
L. casei DG® strain in the feces
the recovery of L. casei DG® strain in the feces
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start6 Nov 2017
- Primary completion4 May 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for IBS - Irritable Bowel SyndromeStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- SOFAR S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 1Med
- Responsible party
- Sponsor
- Investigators
- Giovanni Barbara, MD, Principal investigator, AUO Sant'Orsola Malpighi Bologna (Gastroenterology)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449628
- Sponsor's protocol ID
- PSC-DS PROBE2-IBS/17
- Acronym
- PROBE2
- Status last verified
- May 2022
- First submitted
- 7 Feb 2018
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mearin F, Lacy BE, Chang L, Chey WD, Lembo AJ, Simren M, Spiller R. Bowel Disorders. Gastroenterology. 2016 Feb 18:S0016-5085(16)00222-5. doi: 10.1053/j.gastro.2016.02.031. Online ahead of print.
PubMed 27144627Barbara G, Feinle-Bisset C, Ghoshal UC, Quigley EM, Santos J, Vanner S, Vergnolle N, Zoetendal EG. The Intestinal Microenvironment and Functional Gastrointestinal Disorders. Gastroenterology. 2016 Feb 18:S0016-5085(16)00219-5. doi: 10.1053/j.gastro.2016.02.028. Online ahead of print.
PubMed 27144620Spiller R, Garsed K. Postinfectious irritable bowel syndrome. Gastroenterology. 2009 May;136(6):1979-88. doi: 10.1053/j.gastro.2009.02.074. Epub 2009 May 7.
PubMed 19457422Schoepfer AM, Schaffer T, Seibold-Schmid B, Muller S, Seibold F. Antibodies to flagellin indicate reactivity to bacterial antigens in IBS patients. Neurogastroenterol Motil. 2008 Oct;20(10):1110-8. doi: 10.1111/j.1365-2982.2008.01166.x. Epub 2008 Aug 6.
PubMed 18694443Langhorst J, Junge A, Rueffer A, Wehkamp J, Foell D, Michalsen A, Musial F, Dobos GJ. Elevated human beta-defensin-2 levels indicate an activation of the innate immune system in patients with irritable bowel syndrome. Am J Gastroenterol. 2009 Feb;104(2):404-10. doi: 10.1038/ajg.2008.86. Epub 2009 Jan 20.
PubMed 19174795Pimentel M, Morales W, Rezaie A, Marsh E, Lembo A, Mirocha J, Leffler DA, Marsh Z, Weitsman S, Chua KS, Barlow GM, Bortey E, Forbes W, Yu A, Chang C. Development and validation of a biomarker for diarrhea-predominant irritable bowel syndrome in human subjects. PLoS One. 2015 May 13;10(5):e0126438. doi: 10.1371/journal.pone.0126438. eCollection 2015.
PubMed 25970536Rajilic-Stojanovic M, Biagi E, Heilig HG, Kajander K, Kekkonen RA, Tims S, de Vos WM. Global and deep molecular analysis of microbiota signatures in fecal samples from patients with irritable bowel syndrome. Gastroenterology. 2011 Nov;141(5):1792-801. doi: 10.1053/j.gastro.2011.07.043. Epub 2011 Aug 5.
PubMed 21820992Jalanka-Tuovinen J, Salojarvi J, Salonen A, Immonen O, Garsed K, Kelly FM, Zaitoun A, Palva A, Spiller RC, de Vos WM. Faecal microbiota composition and host-microbe cross-talk following gastroenteritis and in postinfectious irritable bowel syndrome. Gut. 2014 Nov;63(11):1737-45. doi: 10.1136/gutjnl-2013-305994. Epub 2013 Dec 5.
PubMed 24310267Simren M, Barbara G, Flint HJ, Spiegel BM, Spiller RC, Vanner S, Verdu EF, Whorwell PJ, Zoetendal EG; Rome Foundation Committee. Intestinal microbiota in functional bowel disorders: a Rome foundation report. Gut. 2013 Jan;62(1):159-76. doi: 10.1136/gutjnl-2012-302167. Epub 2012 Jun 22.
PubMed 22730468Moayyedi P, Ford AC, Talley NJ, Cremonini F, Foxx-Orenstein AE, Brandt LJ, Quigley EM. The efficacy of probiotics in the treatment of irritable bowel syndrome: a systematic review. Gut. 2010 Mar;59(3):325-32. doi: 10.1136/gut.2008.167270. Epub 2008 Dec 17.
PubMed 19091823
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L. Casei DG® (Lactobacillus Paracasei CNCMI1572) in the Treatment of Patients With Irritable Bowel Syndrome: a Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo Controlled Study.
- ClinicalTrials.gov ID
- NCT03449628
- Acronym / sponsor ID
- PROBE2 / PSC-DS PROBE2-IBS/17
- Conditions
- IBS - Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- SOFAR S.p.A.Industry (pharma, biotech, devices)
- Collaborators
- 1Med
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 28 Feb 2018 (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.
To assess the effect of L. casei DG® (Lactobacillus paracasei CNCMI1572; Enterolactis® plus) on abdominal symptoms and gut microbiota metabolism/composition in non constipated patients with IBS (Irritable Bowel Syndrome). Patients will be randomized to receive L. casei DG® capsules, b.i.d. for 12 weeks the a 4 weeks Follow Up period will follow.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L. casei DG® | Experimental | Dietary Supplement: L.casei DGInterventions: Lactobacillus paracasei CNCMI1572 (At least 24 billion live cells per capsule) 1 capsule, b.i.d. for 12 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PLACEBOInterventions : capsules for oral use, indistinguishable from active product. 1 capsule, b.i.d. for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age > 18 years and ≤ 65 years
- A positive diagnosis of non constipated IBS (i.e., IBS-D and IBS-M, both males and females), according to Rome IV criteria.
- A negative outcome of colonoscopy performed within 5 years before screening if patient is at least 50 years old, or if patient meet any of the following alarm features:
- Negative relevant additional screening or consultation whenever appropriate
- Ability to conform to the study protocol.
Key exclusion criteria (13 listed)
- Patients with IBS-C or IBS-U according to Rome IV criteria
- Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant on the basis of predefined values, (i.e..liver or kidney functional levels 2-times greater than the upper reference values)
- Ascertained intestinal organic diseases, including celiac disease, food allergies or inflammatory bowel diseases (Crohn's disease, ulcerative colitis, diverticular disease, infectious colitis, ischemic colitis, microscopic colitis).
- Previous major abdominal surgery.
- Active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrolment are also acceptable).
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 |
|---|---|---|
| L.casei DG(At least 24 billion live cells per capsule) 1 capsule, b.i.d. for 12 weeks | Dietary supplement | L. casei DG® |
| PLACEBO1 capsule, b.i.d. for 12 weeks | Dietary supplement | Placebo |
Primary outcome
Proportion of patients who have a response in pain
Time frame: 12 weeks
Patients who record on ≥ 50% of the days a reduction of ≥ 30% from their average baseline score for their worst abdominal pain.The standard 11-point numeric rating scale (from 0=none to 10=worst possible pain) will be used to measure abdominal pain.
Proportion of patients who have a response in stool consistencies
Time frame: 12 weeks
Patients who record a stool-consistency score < 5 in the same days in which they record a reduction of ≥ 30% from their average baseline score for their worst abdominal pain .For abnormal defecation, stool frequency and form will be measured using the Bristol Stool Form Scale (BSFS).
16 secondary outcomes
Evaluation of Pain relief
Time frame: 16 weeks
Evaluation of global symptom score
Time frame: 16 weeks
Relief of IBS symptoms
Time frame: 16 weeks
IBS-SSS score questionnaire (Severity Scoring System )
Time frame: 16 weeks
Improvement in stool consistency
Time frame: 16 weeks
Satisfaction with treatment
Time frame: 16 weeks
Quality of life
Time frame: 16 weeks
Intake of rescue medication
Time frame: 16 weeks
gut microbiota composition
Time frame: 16 weeks
Short Chain Fatty Acids (SCFA)
Time frame: 16 weeks
Free Aminoacids
Time frame: 16 weeks
Biogenic Amines
Time frame: 16 weeks
Gut permeability for zonulin
Time frame: 16 weeks
Gut permeability for citrulline
Time frame: 16 weeks
Gut permeability for PV-1 (Plasmalemma vesicle-associated) protein
Time frame: 16 weeks
L. casei DG® strain in the feces
Time frame: 16 weeks
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 6 May 2022.
- Background: PubMed 27144627Mearin F, Lacy BE, Chang L, Chey WD, Lembo AJ, Simren M, Spiller R. Bowel Disorders. Gastroenterology. 2016 Feb 18:S0016-5085(16)00222-5. doi: 10.1053/j.gastro.2016.02.031. Online ahead of print.
- Background: PubMed 27144620Barbara G, Feinle-Bisset C, Ghoshal UC, Quigley EM, Santos J, Vanner S, Vergnolle N, Zoetendal EG. The Intestinal Microenvironment and Functional Gastrointestinal Disorders. Gastroenterology. 2016 Feb 18:S0016-5085(16)00219-5. doi: 10.1053/j.gastro.2016.02.028. Online ahead of print.
- Background: PubMed 19457422Spiller R, Garsed K. Postinfectious irritable bowel syndrome. Gastroenterology. 2009 May;136(6):1979-88. doi: 10.1053/j.gastro.2009.02.074. Epub 2009 May 7.
- Background: PubMed 18694443Schoepfer AM, Schaffer T, Seibold-Schmid B, Muller S, Seibold F. Antibodies to flagellin indicate reactivity to bacterial antigens in IBS patients. Neurogastroenterol Motil. 2008 Oct;20(10):1110-8. doi: 10.1111/j.1365-2982.2008.01166.x. Epub 2008 Aug 6.
- Background: PubMed 19174795Langhorst J, Junge A, Rueffer A, Wehkamp J, Foell D, Michalsen A, Musial F, Dobos GJ. Elevated human beta-defensin-2 levels indicate an activation of the innate immune system in patients with irritable bowel syndrome. Am J Gastroenterol. 2009 Feb;104(2):404-10. doi: 10.1038/ajg.2008.86. Epub 2009 Jan 20.
- Background: PubMed 25970536Pimentel M, Morales W, Rezaie A, Marsh E, Lembo A, Mirocha J, Leffler DA, Marsh Z, Weitsman S, Chua KS, Barlow GM, Bortey E, Forbes W, Yu A, Chang C. Development and validation of a biomarker for diarrhea-predominant irritable bowel syndrome in human subjects. PLoS One. 2015 May 13;10(5):e0126438. doi: 10.1371/journal.pone.0126438. eCollection 2015.
- Background: PubMed 21820992Rajilic-Stojanovic M, Biagi E, Heilig HG, Kajander K, Kekkonen RA, Tims S, de Vos WM. Global and deep molecular analysis of microbiota signatures in fecal samples from patients with irritable bowel syndrome. Gastroenterology. 2011 Nov;141(5):1792-801. doi: 10.1053/j.gastro.2011.07.043. Epub 2011 Aug 5.
- Background: PubMed 24310267Jalanka-Tuovinen J, Salojarvi J, Salonen A, Immonen O, Garsed K, Kelly FM, Zaitoun A, Palva A, Spiller RC, de Vos WM. Faecal microbiota composition and host-microbe cross-talk following gastroenteritis and in postinfectious irritable bowel syndrome. Gut. 2014 Nov;63(11):1737-45. doi: 10.1136/gutjnl-2013-305994. Epub 2013 Dec 5.
- Background: PubMed 22730468Simren M, Barbara G, Flint HJ, Spiegel BM, Spiller RC, Vanner S, Verdu EF, Whorwell PJ, Zoetendal EG; Rome Foundation Committee. Intestinal microbiota in functional bowel disorders: a Rome foundation report. Gut. 2013 Jan;62(1):159-76. doi: 10.1136/gutjnl-2012-302167. Epub 2012 Jun 22.
- Background: PubMed 19091823Moayyedi P, Ford AC, Talley NJ, Cremonini F, Foxx-Orenstein AE, Brandt LJ, Quigley EM. The efficacy of probiotics in the treatment of irritable bowel syndrome: a systematic review. Gut. 2010 Mar;59(3):325-32. doi: 10.1136/gut.2008.167270. Epub 2008 Dec 17.
- 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.
Giovanni Barbara, MD principal investigator
AUO Sant'Orsola Malpighi Bologna (Gastroenterology)
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L.casei DG in people with IBS - Irritable Bowel Syndrome, run by SOFAR S.p.A. at 20 sites 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 9 inclusion and 13 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 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites 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?
Proportion of patients who have a response in pain (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 NCT03449628, which also lists 10 linked publications.
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 6 May 2022.