Irritable Bowel SyndromeNCT04662502
Efficacy of Bifidobacterium Longum 35624 on the Quality of Life of IBS Patients With Different Symptom Severity
An observational study of Irritable Bowel Syndrome, run by Biocodex at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Bifidobacterium longum 35624
- Type of treatment
- Pill or oral medicine
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- 22 Nov 2018to 26 Jun 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult outpatients with IBS consulting a gastroenterologist
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational, Prospective, Multicentric Study of the Effect of Bifidobacterium Longum 35624 on Quality of Life of Patients With Irritable Bowel Syndrome
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
Read the 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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Bifidobacterium longum 35624
- 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.
Bifidobacterium longum 35624Dietary supplement
Bifidobacterium longum 35624, 1 x 10^9 CFU/capsule, 1 capsule/day over 1 month
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life assessed with the Irritable Bowel Syndrome Quality Of Life questionnaire (IBS-QOL).
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.
Measured: Assessed at baseline and after 1 month of treatment
Secondary outcomes (7)
Quality of life subscores assessed with the Irritable Bowel Syndrome Quality Of Life questionnaire (IBS-QOL).
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.
Measured: Assessed at baseline and after 1 month of treatment
IBS Symptom Severity
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)
Measured: Assessed at baseline and after 1 month of treatment
Change of Stool consistency
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.
Measured: Assessed at baseline, day10, day 20 and day 30
Compliance to the treatment
Compliance assessed with patient self-report on a diary
Measured: Assessed after 1 month of treatment
Patient satisfaction
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
Measured: Assessed after 1 month of treatment
Patient's overall impression after 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."
Measured: Assessed after 1 month of treatment
Physician's satisfaction
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
Measured: Assessed after 1 month of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start22 Nov 2018
- Primary completion29 Jan 2020
- Study completion26 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocodex
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gyasi K Johnson, PhD, Study director, Biocodex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662502
- Sponsor's protocol ID
- Floravie
- Status last verified
- Mar 2021
- First submitted
- 18 Nov 2020
- Last updated
- 12 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Prospective, Multicentric Study of the Effect of Bifidobacterium Longum 35624 on Quality of Life of Patients With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT04662502
- Acronym / sponsor ID
- Floravie
- Conditions
- Irritable Bowel Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- BiocodexIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2018 (actual)
- Primary completion
- 29 Jan 2020 (actual)
- Study completion
- 26 Jun 2020 (actual)
- First posted
- 10 Dec 2020 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult outpatients with IBS consulting a gastroenterologist
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Bifidobacterium longum 35624Bifidobacterium longum 35624, 1 x 10^9 CFU/capsule, 1 capsule/day over 1 month | Dietary supplement | – |
Primary outcome
Quality of life assessed with the Irritable Bowel Syndrome Quality Of Life questionnaire (IBS-QOL).
Time frame: 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.
7 secondary outcomes
Quality of life subscores assessed with the Irritable Bowel Syndrome Quality Of Life questionnaire (IBS-QOL).
Time frame: Assessed at baseline and after 1 month of treatment
IBS Symptom Severity
Time frame: Assessed at baseline and after 1 month of treatment
Change of Stool consistency
Time frame: Assessed at baseline, day10, day 20 and day 30
Compliance to the treatment
Time frame: Assessed after 1 month of treatment
Patient satisfaction
Time frame: Assessed after 1 month of treatment
Patient's overall impression after treatment
Time frame: Assessed after 1 month of treatment
Physician's satisfaction
Time frame: Assessed after 1 month of treatment
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 12 Mar 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
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.
Gyasi K Johnson, PhD study director
Biocodex
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome, run by Biocodex at 1 site in France.
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 4 inclusion and 8 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 12 Mar 2021. 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 France. 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. 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?
Quality of life assessed with the Irritable Bowel Syndrome Quality Of Life questionnaire (IBS-QOL). (time frame: Assessed at baseline and after 1 month of treatment). 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 12 Mar 2021.