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Completed

NCT Number: NCT04662502

Efficacy of Bifidobacterium Longum 35624 on the Quality of Life of IBS Patients With Different Symptom Severity

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

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Avicenne

Bobigny, 93009, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bifidobacterium longum 35624

Dietary Supplement

Bifidobacterium longum 35624, 1 x 10^9 CFU/capsule, 1 capsule/day over 1 month

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

  2. IBS Symptom Severity

    Time frame: 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)

  3. Change of Stool consistency

    Time frame: 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.

  4. Compliance to the treatment

    Time frame: Assessed after 1 month of treatment

    Compliance assessed with patient self-report on a diary

  5. Patient satisfaction

    Time frame: 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

  6. Patient's overall impression after treatment

    Time frame: 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."

  7. Physician's satisfaction

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Biocodex

Industry

Registry information

Official study title

Observational, Prospective, Multicentric Study of the Effect of Bifidobacterium Longum 35624 on Quality of Life of Patients With Irritable Bowel Syndrome

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 10, 2020
Registry last updated
Mar 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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