Irritable Bowel Syndrome
Conditions
Brief summary
The main objective of this observatory is to evaluate the effect of Bifidobacterium longum 35624 on the quality of life of IBS patients having different subtypes of transit pattern and different level of symptom severity
Detailed description
This observatory evaluate the effect of Bifidobacterium longum 35624 on the quality of life of IBS patients having different subtypes of transit pattern and different level of symptom severity, after a one-month treatment with Bibidobacterium longum 35624, 1x10\^9 CFU/capsule, 1 capsule/day.
Interventions
DIETARY_SUPPLEMENTBifidobacterium longum 35624
Bifidobacterium longum 35624, 1 x 10\^9 CFU/capsule, 1 capsule/day over 1 month
Sponsors
Biocodex
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, at least 18 years of age * Gastroenterology consultation for an Irritable Bowel Syndrome according to Rome IV criteria * Having received a first prescription of Bifidobacterium longum 35624 during the consultation (independently of participation in the observatory) * Informed and having declared his/her non-opposition to the study.
Exclusion criteria
* Not having a good enough command of reading and comprehension of the French language to correctly complete the questionnaires and the notebook * Having already taken Bifidobacterium longum 35624 * Having received probiotics or antibiotics within 2 weeks previous * Having started within the last 7 days a treatment that can interfere with the investigator's evaluation of the investigational product under investigation * Participant in another trial * Pregnant or breastfeeding women * Being under guardianship or curator. * Not having a good enough command of reading and comprehension of the French language to correctly complete the questionnaires and the notebook
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life assessed with the Irritable Bowel Syndrome Quality Of Life questionnaire (IBS-QOL). | Assessed at baseline and after 1 month of treatment | Change from baseline of quality of life as assessed with the Irritable Bowel Syndrome Quality Of Life questionnaire (IBS-QOL, scoring from 0 to 100, with higher scores indicating better IBS specific quality of life) in IBS patients having different subtypes of transit pattern and different level of symptom severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IBS Symptom Severity | Assessed at baseline and after 1 month of treatment | Change of IBS Symptom Severity assessed with the IBS Severity Scoring System (IBS-SSS, scoring from 0 to 500, with higher scores indicating worse severity of IBS symptoms) |
| Change of Stool consistency | Assessed at baseline, day10, day 20 and day 30 | Change of stool consistency assessed with the Bristol stool scale. The Bristol Stool Chart classifies stool according to their shape and consistency and assigns a sample a number from 1-7 depending on its characteristics, corresponding to constipation normal or diarrhea. |
| Compliance to the treatment | Assessed after 1 month of treatment | Compliance assessed with patient self-report on a diary |
| Quality of life subscores assessed with the Irritable Bowel Syndrome Quality Of Life questionnaire (IBS-QOL). | Assessed at baseline and after 1 month of treatment | Change from baseline of quality of life subscores as assessed with the Irritable Bowel Syndrome Quality Of Life questionnaire (IBS-QOL, scoring from 0 to 100, with higher scores indicating better IBS specific quality of life) in IBS patients having different subtypes of transit pattern and different level of symptom severity. |
| Patient's overall impression after treatment | Assessed after 1 month of treatment | The patient's overall impression of how the product has changed his or her daily activities, symptoms, and quality of life, assessed with the Patients' Global Impression of Change (PGIC) scale. PGIC is a 7-point scale describing patient's rating of overall improvement. Change is rated by patients as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. |
| Physician's satisfaction | Assessed after 1 month of treatment | Physician satisfaction with the treatment for his/her patient assessed on a 5-point Likert scale, with proposals ranked in ascending order of satisfaction as 1- Not at all satisfied; 2- Unsatisfied; 3- Somewhat satisfied; 4-Satisfied to 5-Very satisfied |
| Patient satisfaction | Assessed after 1 month of treatment | Patient satisfaction with treatment assessed on a 5-point Likert scale, with proposals ranked in ascending order of satisfaction as 1- Not at all satisfied; 2- Unsatisfied; 3- Somewhat satisfied; 4-Satisfied to 5-Very satisfied |
Countries
France
Outcome results
None listed