Irritable Bowel SyndromeNCT02371499
Effect of Lactobacillus Casei DG (Enterolactis Plus®) in Patient With Irritable Bowel Syndrome: a Pilot Study
A study testing Lactobacillus casei DG in people with Irritable Bowel Syndrome, run by SOFAR S.p.A. at 5 sites in Italy.
Trial summary
The aim of the study is to collect data for the assessment of the Lactobacillus casei DG (Enterolactis plus®) effect on overall abdominal pain/discomfort, symptoms and gut microbiota composition in patients with Irritable Bowel Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Lactobacillus casei DG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 5 sitesItaly
- Study dates
- Dec 2014to Nov 2015
- 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 Irritable Bowel Syndrome regardless of bowel habit (both males and females), according to Rome III criteria.
- Negative outcome of barium enema or left colonoscopy within the previous two years.
- Negative relevant additional screening or consultation whenever appropriate.
- Ability of conforming to the study protocol.
Who cannot join
- 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.
- Ascertained intestinal organic diseases, including ascertained celiac disease or inflammatory bowel diseases (Crohn's disease, ulcerative colitis, diverticular disease, infectious colitis, ischemic colitis, microscopic colitis).
- Previous major abdominal surgeries.
- 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.
- Assumption of probiotics or topic and/or systemic antibiotic therapy during the last month.
Show all 13Show fewer
- Systematical/frequent assumption of contact laxatives.
- Females of childbearing potential, in the absence of effective contraceptive methods.
- Pregnant women.
- Inability to conform with protocol.
- Treatment with any investigational drug within the previous 30 days.
- Recent history or suspicion of alcohol abuse or drug addiction.
- Previous participation in this study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
Azienda ULSS 1
Belluno
Azienda Ospedaliero-Universitaria S. Orsola Malpighi
Bologna, 40100
U.O. Gastroenterologia Universitaria
Pisa, Pisa
Policlinico Universitario Campus Biomedico
Roma, 00128
Policlinico S.Donato
San Donato, Milano, 20097
About this study
Official title: Effect of Lactobacillus Casei dg (Enterolactis Plus®) in Patient With Irritable Bowel Syndrome: Multicenter, Randomized, Double-blind, Cross-over, Placebo Controlled, Pilot Study
The aim of the study is to collect data for the assessment of the Lactobacillus casei DG (Enterolactis plus®) effect on overall abdominal pain/discomfort, symptoms and gut microbiota composition in patients with Irritable Bowel Syndrome.
Read the detailed description
The aim of the study is to collect data for the assessment of the Lactobacillus casei DG (Enterolactis plus®) effect on overall abdominal pain/discomfort, symptoms and gut microbiota composition in patients with Irritable Bowel Syndrome. The investigators suppose that, due to the immunomodulatory action of probiotics, overall abdominal pain/discomfort and symptoms will improve, fecal Immunoglobulin A levels will change, pro-inflammatory cytokine levels will decrease and the production of regulatory cytokines as Interleukin 10 will improve following consumption of Lactobacillus casei DG (Enterolactis plus®).
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Lactobacillus casei DG, Placebo
- Keywords
- Irritable Bowel Syndrome, Lactobacillus casei dg, microbiota
- 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.
Lactobacillus casei DGDietary supplement
Also called Enterolactis plus®
the patients will receive 1 capsule of Lactobacillus casei DG (Enterolactis plus®) twice daily for 4 weeks
PlaceboDietary supplement
the patients will receive 1 capsule of product without bacteria (Enterolactis placebo) twice daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1st Arm | Experimental | Treatment with Lactobacillus casei DG (Enterolactis plus®) Receives: Dietary Supplement: Lactobacillus casei DG |
| 2nd Arm | Placebo comparator | Treatment with equivalent product without bacteria (Enterolactis placebo) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal pain/discomfort as measured by 11-point Numerical Rating Scale
evaluation performed using a daily 11-point Numerical Rating Scale scale from "0" (none) to "10" (very severe) - (responders are defined as patients with ≥ 30% reduction in the weekly mean abdominal pain and/or discomfort score, versus mean value of run-in period, in at least 2 weeks out of the 4 weeks of the treatment period)
Measured: 1 day
Irritable Bowel Syndrome degree-of-relief as measured by 7-point balanced ordinal scale
evaluation performed using weekly 7-point balanced ordinal scale, where "1"="completely relieved", "4"="unchanged" and "7"="as bad as I can imagine" - (responders are defined as patients reporting "completely relieved"=score 1 or "considerably relieved"=score 2 in at least 2 weeks out of the 4 weeks of the treatment period)
Measured: 1 week
Stool frequency and consistency as assessed by Bristol Scale
Measured: 1 day
Microbiota of fecal sample as characterized by Ion Torrent Personal Genome Machine sequencing of 16S ribosomal RNA-based amplicons
Measured: 4 weeks
Overall satisfaction with treatment as measured by Visual Analogue Scale
Measured: 4 weeks
Quality of life as measured by Short-Form 12 Items Health Survey
evaluation performed using the validated Short-Form 12 Items Health Survey (SF-12) on a scale of 0 to 100
Measured: 4 weeks
Anxiety and Depression as assessed by Hospital Anxiety and Depression Scale (HADS)
evaluation performed using Hospital Anxiety and Depression Scale (HADS): seven items each for anxiety and depression, with a 4-point Likert scale (0-3) for each item providing a minimum score of 0 and a maximum score of 21 on each sub-scale
Measured: 4 weeks
Consumption of rescue medication
Measured: 1 day
Secretory Immunoglobulin A and cytokines levels in fecal samples as measured by ELISA test.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startDec 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- SOFAR S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giorvanni Barbara, MD, Principal investigator, Policlinico S. Orsola-Malpighi - Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371499
- Sponsor's protocol ID
- PROBE-IBS/14
- Status last verified
- Feb 2016
- First submitted
- 11 Feb 2015
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional bowel disorders. Gastroenterology. 2006 Apr;130(5):1480-91. doi: 10.1053/j.gastro.2005.11.061.
PubMed 16678561Barbara G, Stanghellini V. Biomarkers in IBS: when will they replace symptoms for diagnosis and management? Gut. 2009 Dec;58(12):1571-5. doi: 10.1136/gut.2008.169672. No abstract available.
PubMed 19923339Cremon C, Carini G, De Giorgio R, Stanghellini V, Corinaldesi R, Barbara G. Intestinal dysbiosis in irritable bowel syndrome: etiological factor or epiphenomenon? Expert Rev Mol Diagn. 2010 May;10(4):389-93. doi: 10.1586/erm.10.33.
PubMed 20465494Simren 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 22730468Rajilic-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 21820992Jeffery IB, O'Toole PW, Ohman L, Claesson MJ, Deane J, Quigley EM, Simren M. An irritable bowel syndrome subtype defined by species-specific alterations in faecal microbiota. Gut. 2012 Jul;61(7):997-1006. doi: 10.1136/gutjnl-2011-301501. Epub 2011 Dec 16.
PubMed 22180058Moayyedi 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 19091823Madsen K, Cornish A, Soper P, McKaigney C, Jijon H, Yachimec C, Doyle J, Jewell L, De Simone C. Probiotic bacteria enhance murine and human intestinal epithelial barrier function. Gastroenterology. 2001 Sep;121(3):580-91. doi: 10.1053/gast.2001.27224.
PubMed 11522742Eun CS, Kim YS, Han DS, Choi JH, Lee AR, Park YK. Lactobacillus casei prevents impaired barrier function in intestinal epithelial cells. APMIS. 2011 Jan;119(1):49-56. doi: 10.1111/j.1600-0463.2010.02691.x. Epub 2010 Oct 25.
PubMed 21143526Corinaldesi R, Stanghellini V, Cremon C, Gargano L, Cogliandro RF, De Giorgio R, Bartesaghi G, Canovi B, Barbara G. Effect of mesalazine on mucosal immune biomarkers in irritable bowel syndrome: a randomized controlled proof-of-concept study. Aliment Pharmacol Ther. 2009 Aug;30(3):245-52. doi: 10.1111/j.1365-2036.2009.04041.x. Epub 2009 May 12.
PubMed 19438846Quigley EM, Tack J, Chey WD, Rao SS, Fortea J, Falques M, Diaz C, Shiff SJ, Currie MG, Johnston JM. Randomised clinical trials: linaclotide phase 3 studies in IBS-C - a prespecified further analysis based on European Medicines Agency-specified endpoints. Aliment Pharmacol Ther. 2013 Jan;37(1):49-61. doi: 10.1111/apt.12123. Epub 2012 Nov 1.
PubMed 23116208Cremon C, Guglielmetti S, Gargari G, Taverniti V, Castellazzi AM, Valsecchi C, Tagliacarne C, Fiore W, Bellini M, Bertani L, Gambaccini D, Cicala M, Germana B, Vecchi M, Pagano I, Barbaro MR, Bellacosa L, Stanghellini V, Barbara G. Effect of Lactobacillus paracasei CNCM I-1572 on symptoms, gut microbiota, short chain fatty acids, and immune activation in patients with irritable bowel syndrome: A pilot randomized clinical trial. United European Gastroenterol J. 2018 May;6(4):604-613. doi: 10.1177/2050640617736478. Epub 2017 Oct 8.
PubMed 29881616
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lactobacillus Casei dg (Enterolactis Plus®) in Patient With Irritable Bowel Syndrome: Multicenter, Randomized, Double-blind, Cross-over, Placebo Controlled, Pilot Study
- ClinicalTrials.gov ID
- NCT02371499
- Acronym / sponsor ID
- PROBE-IBS/14
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, Lactobacillus casei dg, microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- SOFAR S.p.A.Industry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 25 Feb 2015 (estimated)
- 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 aim of the study is to collect data for the assessment of the Lactobacillus casei DG (Enterolactis plus®) effect on overall abdominal pain/discomfort, symptoms and gut microbiota composition in patients with Irritable Bowel Syndrome.
Detailed description
The aim of the study is to collect data for the assessment of the Lactobacillus casei DG (Enterolactis plus®) effect on overall abdominal pain/discomfort, symptoms and gut microbiota composition in patients with Irritable Bowel Syndrome. The investigators suppose that, due to the immunomodulatory action of probiotics, overall abdominal pain/discomfort and symptoms will improve, fecal Immunoglobulin A levels will change, pro-inflammatory cytokine levels will decrease and the production of regulatory cytokines as Interleukin 10 will improve following consumption of Lactobacillus casei DG (Enterolactis plus®).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1st Arm | Experimental | Dietary Supplement: Lactobacillus casei DGTreatment with Lactobacillus casei DG (Enterolactis plus®) |
| 2nd Arm | Placebo comparator | Dietary Supplement: PlaceboTreatment with equivalent product without bacteria (Enterolactis placebo) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years and ≤ 65 years.
- A positive diagnosis of Irritable Bowel Syndrome regardless of bowel habit (both males and females), according to Rome III criteria.
- Negative outcome of barium enema or left colonoscopy within the previous two years.
- Negative relevant additional screening or consultation whenever appropriate.
- Ability of conforming to the study protocol.
Key exclusion criteria (13 listed)
- 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.
- Ascertained intestinal organic diseases, including ascertained celiac disease or inflammatory bowel diseases (Crohn's disease, ulcerative colitis, diverticular disease, infectious colitis, ischemic colitis, microscopic colitis).
- Previous major abdominal surgeries.
- 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.
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 |
|---|---|---|
| Lactobacillus casei DGAlso: Enterolactis plus®the patients will receive 1 capsule of Lactobacillus casei DG (Enterolactis plus®) twice daily for 4 weeks | Dietary supplement | 1st Arm |
| Placebothe patients will receive 1 capsule of product without bacteria (Enterolactis placebo) twice daily for 4 weeks | Dietary supplement | 2nd Arm |
Primary outcome
Abdominal pain/discomfort as measured by 11-point Numerical Rating Scale
Time frame: 1 day
evaluation performed using a daily 11-point Numerical Rating Scale scale from "0" (none) to "10" (very severe) - (responders are defined as patients with ≥ 30% reduction in the weekly mean abdominal pain and/or discomfort score, versus mean value of run-in period, in at least 2 weeks out of the 4 weeks of the treatment period)
Irritable Bowel Syndrome degree-of-relief as measured by 7-point balanced ordinal scale
Time frame: 1 week
evaluation performed using weekly 7-point balanced ordinal scale, where "1"="completely relieved", "4"="unchanged" and "7"="as bad as I can imagine" - (responders are defined as patients reporting "completely relieved"=score 1 or "considerably relieved"=score 2 in at least 2 weeks out of the 4 weeks of the treatment period)
Stool frequency and consistency as assessed by Bristol Scale
Time frame: 1 day
Microbiota of fecal sample as characterized by Ion Torrent Personal Genome Machine sequencing of 16S ribosomal RNA-based amplicons
Time frame: 4 weeks
Overall satisfaction with treatment as measured by Visual Analogue Scale
Time frame: 4 weeks
Quality of life as measured by Short-Form 12 Items Health Survey
Time frame: 4 weeks
evaluation performed using the validated Short-Form 12 Items Health Survey (SF-12) on a scale of 0 to 100
Anxiety and Depression as assessed by Hospital Anxiety and Depression Scale (HADS)
Time frame: 4 weeks
evaluation performed using Hospital Anxiety and Depression Scale (HADS): seven items each for anxiety and depression, with a 4-point Likert scale (0-3) for each item providing a minimum score of 0 and a maximum score of 21 on each sub-scale
Consumption of rescue medication
Time frame: 1 day
Secretory Immunoglobulin A and cytokines levels in fecal samples as measured by ELISA test.
Time frame: 4 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 2 Feb 2016.
- Background: PubMed 16678561Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional bowel disorders. Gastroenterology. 2006 Apr;130(5):1480-91. doi: 10.1053/j.gastro.2005.11.061.
- Background: PubMed 19923339Barbara G, Stanghellini V. Biomarkers in IBS: when will they replace symptoms for diagnosis and management? Gut. 2009 Dec;58(12):1571-5. doi: 10.1136/gut.2008.169672. No abstract available.
- Background: PubMed 20465494Cremon C, Carini G, De Giorgio R, Stanghellini V, Corinaldesi R, Barbara G. Intestinal dysbiosis in irritable bowel syndrome: etiological factor or epiphenomenon? Expert Rev Mol Diagn. 2010 May;10(4):389-93. doi: 10.1586/erm.10.33.
- 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 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 22180058Jeffery IB, O'Toole PW, Ohman L, Claesson MJ, Deane J, Quigley EM, Simren M. An irritable bowel syndrome subtype defined by species-specific alterations in faecal microbiota. Gut. 2012 Jul;61(7):997-1006. doi: 10.1136/gutjnl-2011-301501. Epub 2011 Dec 16.
- 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.
- Background: PubMed 11522742Madsen K, Cornish A, Soper P, McKaigney C, Jijon H, Yachimec C, Doyle J, Jewell L, De Simone C. Probiotic bacteria enhance murine and human intestinal epithelial barrier function. Gastroenterology. 2001 Sep;121(3):580-91. doi: 10.1053/gast.2001.27224.
- Background: PubMed 21143526Eun CS, Kim YS, Han DS, Choi JH, Lee AR, Park YK. Lactobacillus casei prevents impaired barrier function in intestinal epithelial cells. APMIS. 2011 Jan;119(1):49-56. doi: 10.1111/j.1600-0463.2010.02691.x. Epub 2010 Oct 25.
- Background: PubMed 19438846Corinaldesi R, Stanghellini V, Cremon C, Gargano L, Cogliandro RF, De Giorgio R, Bartesaghi G, Canovi B, Barbara G. Effect of mesalazine on mucosal immune biomarkers in irritable bowel syndrome: a randomized controlled proof-of-concept study. Aliment Pharmacol Ther. 2009 Aug;30(3):245-52. doi: 10.1111/j.1365-2036.2009.04041.x. Epub 2009 May 12.
- Background: PubMed 23116208Quigley EM, Tack J, Chey WD, Rao SS, Fortea J, Falques M, Diaz C, Shiff SJ, Currie MG, Johnston JM. Randomised clinical trials: linaclotide phase 3 studies in IBS-C - a prespecified further analysis based on European Medicines Agency-specified endpoints. Aliment Pharmacol Ther. 2013 Jan;37(1):49-61. doi: 10.1111/apt.12123. Epub 2012 Nov 1.
- Derived from this study: PubMed 29881616Cremon C, Guglielmetti S, Gargari G, Taverniti V, Castellazzi AM, Valsecchi C, Tagliacarne C, Fiore W, Bellini M, Bertani L, Gambaccini D, Cicala M, Germana B, Vecchi M, Pagano I, Barbaro MR, Bellacosa L, Stanghellini V, Barbara G. Effect of Lactobacillus paracasei CNCM I-1572 on symptoms, gut microbiota, short chain fatty acids, and immune activation in patients with irritable bowel syndrome: A pilot randomized clinical trial. United European Gastroenterol J. 2018 May;6(4):604-613. doi: 10.1177/2050640617736478. Epub 2017 Oct 8.
- 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.
Giorvanni Barbara, MD principal investigator
Policlinico S. Orsola-Malpighi - Azienda Ospedaliero-Universitaria di Bologna
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus casei DG in people with Irritable Bowel Syndrome, run by SOFAR S.p.A. at 5 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 5 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 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Abdominal pain/discomfort as measured by 11-point Numerical Rating Scale (time frame: 1 day). The study lists 9 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 NCT02371499, which also lists 12 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 2 Feb 2016.