An interventional study of L.casei DG and PLACEBO in IBS - Irritable Bowel Syndrome, sponsored by SOFAR S.p.A.. Completed at 20 sites in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-05-06.
Sponsored by SOFAR S.p.A. · Not applicable, Interventional, and Treatment
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.
1,116 studies on the registry are indexed under Irritable Bowel Syndrome; 208 are open to participants now.
This study's enrollment of 264 is above the median of 70 across 896 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →SOFAR S.p.A. is the lead sponsor of 15 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Interventions: Lactobacillus paracasei CNCMI1572 (At least 24 billion live cells per capsule) 1 capsule, b.i.d. for 12 weeks
Dietary Supplement: L.casei DG
Interventions : capsules for oral use, indistinguishable from active product. 1 capsule, b.i.d. for 12 weeks
Dietary Supplement: PLACEBO
(At least 24 billion live cells per capsule) 1 capsule, b.i.d. for 12 weeks
1 capsule, b.i.d. for 12 weeks
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.
Time frame: 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).
Time frame: 12 weeks
Evaluation of Pain relief
reduction of ≥ 30% from baseline in the score for the worst abdominal pain on ≥ 50% of days
Time frame: 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
Time frame: 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?)"
Time frame: 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.
Time frame: 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)
Time frame: 16 weeks
Satisfaction with treatment
Overall satisfaction with treatment assessed by VAS scale (Visual Analogue Scale)
Time frame: 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
Time frame: 16 weeks
Intake of rescue medication
type and frequencies of rescue medication
Time frame: 16 weeks
gut microbiota composition
Evaluation of changes in the gut microbiota composition and the relative abundance of bacterial OTUs (Operational Taxonomic Unit).
Time frame: 16 weeks
Short Chain Fatty Acids (SCFA)
Evaluation of Short Chain Fatty Acids levels in fecal samples
Time frame: 16 weeks
Free Aminoacids
Evaluation of Free aminoacids levels in fecal samples
Time frame: 16 weeks
Biogenic Amines
Evaluation of biogenic amines levels in fecal samples
Time frame: 16 weeks
Gut permeability for zonulin
evaluation of serum levels of zonulin
Time frame: 16 weeks
Gut permeability for citrulline
evaluation of serum levels of citrulline
Time frame: 16 weeks
Gut permeability for PV-1 (Plasmalemma vesicle-associated) protein
evaluation of serum levels of PV-1 (Plasmalemma vesicle-associated) protein
Time frame: 16 weeks
L. casei DG® strain in the feces
the recovery of L. casei DG® strain in the feces
Time frame: 16 weeks
Plan to share: No
Ran from Nov 2017 to primary completion in May 2021, 41 months.
Of 52 industry-sponsored interventional studies with no phase under Irritable Bowel Syndrome, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 28. This study's 41 months is above that.
Counting every sponsor, half of 357 studies reached it within 19 months; a quarter within 9 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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SOFAR S.p.A.