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Observational Study
. 2022 Feb 21;28(7):732-744.
doi: 10.3748/wjg.v28.i7.732.

Effect of Bifidobacterium longum 35624 on disease severity and quality of life in patients with irritable bowel syndrome

Jean-Marc Sabaté  1 , Franck Iglicki  2
Affiliations
Observational Study

Effect of Bifidobacterium longum 35624 on disease severity and quality of life in patients with irritable bowel syndrome

Jean-Marc Sabaté et al. World J Gastroenterol. .

Abstract

Background: Bifidobacterium longum 35624 has shown efficacy in improving irritable bowel syndrome (IBS) symptoms compared with placebo in double-blind randomized studies. However, few data are available from real-life clinical practice or from studies that used Rome IV criteria to diagnose IBS.

Aim: To assess the effect of B. longum 35624 on IBS severity and quality of life in a real-life setting.

Methods: From November 2018 to January 2020, 278 patients with IBS (according to Rome IV criteria) were enrolled in a prospective, open-label, multicenter observational study by private practice gastroenterologists to received one capsule of B. longum 35624 (109 colony-forming units) per day for 30 d. Participation in the study was independently proposed to patients during spontaneous consultations. Disease severity (assessed by the IBS severity scoring system) and patient quality of life (assessed by the IBS quality of life questionnaire) were compared between the inclusion visit (baseline) and the visit at the end of 30 d of treatment. The characteristics of patients were described at baseline. Continuous variables comparisons between inclusion and end-of-treatment visits were performed using the t-test and Kruskal-Wallis test. Categorical variables comparisons were performed using the χ2 test.

Results: A total of 233 patients, with a mean age of 51.4 years and composed of 71.2% women, were included in the study. Of these patients, 48.1% had moderate IBS and 46.4% had severe IBS. After a 30-d treatment period with one B. longum 35624 capsule per day, a significant decrease in IBS severity was observed compared to baseline (mean ± SD, IBS severity scoring system scores: 208 ± 104 vs 303 ± 81, P < 0.001) and 57% of patients moved to lower severity categories or achieved remission. The quality of life of patients was also improved by the treatment (IBS Quality of Life questionnaire score: 68.8 ± 20.9 vs 60.2 ± 20.5; P < 0.001) and 63.8% of patients were satisfied with the treatment.

Conclusion: Thirty days of treatment with B. longum 35624 reduces disease severity and improves the quality of life of patients with IBS, particularly those with the most severe forms of IBS.

Keywords: Abdominal pain; Bifidobacterium longum; Irritable bowel syndrome; Probiotics; Quality of life; Severity of illness index.

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Conflict of interest statement

Conflict-of-interest statement: Sabaté JM and Iglicki F report personal fees from Biocodex during the conduct of the study. Sabaté JM also reports personal fees from Biocodex, Kyowa Kirin, Norgine, Mayoly Spindler, Arko Pharma, and Tillots Pharma outside the submitted work.

Figures

Figure 1
Figure 1
Patient flow. C: Constipation; D: Diarrhea; IBS: Irritable bowel syndrome; M: Mixed; U: “Unclassified” (subtype not determined).
Figure 2
Figure 2
Mean irritable bowel syndrome severity scoring system and Irritable bowel syndrome quality of life score at baseline and at the end of treatment by transit subtype. A: IBS-SSS; B: IBS-QOL. Error bars denote standard deviation. aP < 0.001 versus baseline. IBS: Irritable bowel syndrome; IBS-QOL: Irritable bowel syndrome quality of life; IBS-SSS: Irritable bowel syndrome severity scoring system; C: Constipation; D: Diarrhea; M: Mixed; NS: Not significant; U: Unclassified.
Figure 3
Figure 3
Irritable bowel syndrome quality of life score according to irritable bowel syndrome severity scoring system severity categories at baseline. IBS-QOL: Irritable bowel syndrome quality of life; IBS-SSS: Irritable bowel syndrome severity scoring system.
Figure 4
Figure 4
Mean irritable bowel syndrome severity scoring system and irritable bowel syndrome quality of life score at baseline and at the end of treatment. A: Mean irritable bowel syndrome severity scoring system score at baseline and at the end of treatment; B: Mean irritable bowel syndrome quality of life score at baseline and at the end of treatment. Error bars denote standard deviation. aP < 0.001 vs baseline. IBS-QOL: Irritable bowel syndrome quality of life; IBS-SSS: Irritable bowel syndrome severity scoring system.
Figure 5
Figure 5
Irritable bowel syndrome severity scoring system scores by domain at baseline and after treatment with B. longum 35624. a P < 0.001 vs baseline. IBS-SSS: Irritable bowel syndrome severity scoring system.
Figure 6
Figure 6
Change in the number of patients in different irritable bowel syndrome severity scoring system severity categories from baseline to after treatment with B. longum 35624. A: Number and percentage of patients by Irritable bowel syndrome severity scoring system (IBS-SSS) severity category at baseline (arrows indicate movement from one category to another one after 30 d of treatment with B. longum 35624); B: Number and percentage of patients by IBS-SSS severity category after 30 d of treatment with B. longum 35624. IBS-SSS: Irritable bowel syndrome severity scoring system.
Figure 7
Figure 7
Stool consistency by Bristol stool scale score recorded at baseline and every 10 d over 30 d in IBS-C, IBS-D, IBS-M, and IBS-U. C: Constipation; D: Diarrhea; IBS: Irritable bowel syndrome; M: Mixed; U: “Unclassified” (subtype not determined). A: IBS-C; B: IBS-D; C: IBS-M; D: IBS-U.
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