Probiotiques et intestin irritable : à propos d’une étude randomisée en double aveugle contre placebo sur l’efficacité du mélange de souches Lactibiane Référence sur les symptômes associés à l’intestin irritable

Un intérêt croissant est porté au rôle du microbiote dans la pathogénie de l’intestin irritable et aux probiotiques pour tenter de l’améliorer dans son ensemble ou dans certains de ses composants (notamment les douleurs abdominales). Nous avons évalué l’efficacité d’un complément alimentaire à base de probiotiques, Lactibiane Référence, sur les symptômes associés aux troubles fonctionnels intestinaux (TFI). Cent seize patients souffrant de TFI identifiés selon les critères de Rome II ont été inclus dans une étude clinique randomisée en double aveugle contre placebo. Ils ont reçu pendant 4 semaines un placebo ou Lactibiane Référence (1.1010 ufc une fois par jour). Les symptômes étudiés ont inclus l’inconfort, la douleur abdominale, la fréquence et la qualité des selles et la qualité de vie (évaluée par les échelles SF36 et FDD-QOL). 100 sujets ont terminé l’étude (48 sous Lactibiane Référence, 52 sous placebo). Le mélange probiotiques ne s’est pas révélé supérieur au placebo dans l’amélioration du score global de TFI (42,6 % vs 42,3 % d’amélioration). Par contre, la diminution de la douleur abdominale entre la première et la dernière semaine de traitement était significativement plus importante chez les patients ayant consommé Lactibiane Référence (- 41,9 % vs - 24,2 %, p = 0,048). De plus, l’analyse des sous-groupes a permis de mettre en évidence une augmentation dès le première semaine de traitement de la fréquence des selles chez les patients souffrant de TFI avec constipation prédominante (p = 0,043)

A Dietary Supplement Containing Cinnamon, Chromium and Carnosine Decreases Fasting Plasma Glucose and Increases Lean Mass in Overweight or Obese Pre-Diabetic Subjects: A Randomized, Placebo-Controlled Trial

International audienceBackgroundPreventing or slowing the progression of prediabetes to diabetes is a major therapeutic issue.ObjectivesOur aim was to evaluate the effects of 4-month treatment with a dietary supplement containing cinnamon, chromium and carnosine in moderately obese or overweight pre-diabetic subjects, the primary outcome being change in fasting plasma glucose (FPG) level. Other parameters of plasma glucose homeostasis, lipid profile, adiposity and inflammatory markers were also assessed.MethodsIn a randomized, double-blind, placebo-controlled study, 62 subjects with a FPG level ranging from 5.55 to 7 mmol/L and a body mass index ≥25 kg/m2, unwilling to change their dietary and physical activity habits, were allocated to receive a 4-month treatment with either 1.2 g/day of the dietary supplement or placebo. Patients were followed up until 6 months post-randomization.ResultsFour-month treatment with the dietary supplement decreased FPG compared to placebo (-0.24±0.50 vs +0.12±0.59 mmol/L, respectively, p = 0.02), without detectable significant changes in HbA1c. Insulin sensitivity markers, plasma insulin, plasma lipids and inflammatory markers did not differ between the treatment groups. Although there were no significant differences in changes in body weight and energy or macronutrient intakes between the two groups, fat-free mass (%) increased with the dietary supplement compared to placebo (p = 0.02). Subjects with a higher FPG level and a milder inflammatory state at baseline benefited most from the dietary supplement.ConclusionsFour-month treatment with a dietary supplement containing cinnamon, chromium and carnosine decreased FPG and increased fat-free mass in overweight or obese pre-diabetic subjects. These beneficial effects might open up new avenues in the prevention of diabetes

MSCopilot: New smartphone-based digital biomarkers correlate with Expanded Disability Status Scale scores in people with Multiple Sclerosis

International audienceBackground: A previous clinical study showed the high specificity, sensitivity and reliability of MSCopilot, a software medical device designed by Ad Scientiam for the self-assessment of people with Multiple Sclerosis (PwMS), compared to the traditional Multiple Sclerosis Functional Composite (MSFC). We conducted further analyses to assess MSCopilot's performance with respect to the Expanded Disability Status Scale (EDSS).Methods: The data of 116 PwMS were analysed. We studied the correlations between MSCopilot scores and the EDSS, and their ability to distinguish PwMS with high and low EDSS through a study of the distribution of the digital test scores as well as logistic regression models. The same analyses were performed using the MSFC tests.Results: MSCopilot composite scores were as highly correlated to the EDSS (|r| = 0.65, p 3.5 (R²adj=0.47). The mean values of each MSCopilot subscore were significantly different between patients with an EDSS > 3.5 and others (p 3.5 (AUC = 0.92).Conclusion: These analyses confirm the reliability of MSCopilot and show interesting correlations with the EDSS (similar results obtained with the MSFC). MSCopilot was able to highlight nuances in the different stages of MS the MSFC could not capture

Study variables before and after 4-month treatment with dietary supplement or placebo.

<p>Values are expressed as mean±SD. M4: Month 4; FPG: fasting plasma glucose. FP insulin: fasting plasma insulin; HbA1c: glycated hemoglobin; HOMA-IR: homeostatic model assessment-insulin resistance; HOMA-B (%): β cell function; HOMA-S (%): insulin sensitivity; QUICKI: quantitative insulin sensitivity check index; HDL: high-density lipoprotein; LDL: low-density lipoprotein; FFA: free fatty acids; hs-CRP: high-sensitivity C-reactive protein; PAI-1: plasminogen activator inhibitor-1; IL-6: interleukin-6; Akt: serine/threonine protein kinase B. Baseline data did not differ between groups using unpaired Student t-tests. Baseline and 4-month data in each group were compared using paired Student’s t-tests; Changes (values at 4 months–values at baseline/values at baseline*100) in the placebo and dietary supplement groups were compared using unpaired Student’s t-test.</p

Consort flow diagram.

<p>ITT: intention-to-treat. One subject in the dietary supplement group was lost to follow-up at Month 2, and one subject in the placebo group was withdrawn from the study at Month 2 due to a serious adverse event not related to study treatment (new condition with a need for hormonal treatment).</p

Composition of the dietary supplement and placebo capsules.

<p>HPMC: hydroxy-propyl-methylcellulose.</p

Baseline characteristics of subjects in the intention-to-treat and per-protocol populations.

<p>Values are mean±SD; ITT: intention-to-treat; PP: per-protocol; F: female; M: male. The baseline data in the dietary supplement and placebo groups were compared using Student’s t-tests for quantitative variables and Fisher's exact test for sex. No statistically significant difference was found between the two treatment groups in either of the two study populations.</p

Correlations between changes in FPG or fat-free mass and other bioclinical parameters during dietary supplement treatment.

<p>A: Correlation between changes in fasting plasma glucose and insulin secretion estimated by HOMA-B%. B: Correlations between changes in fat-free mass and changes in insulin sensitivity (estimated by revised QUICKI). C: Correlations between changes in fat-free mass and free fatty acids; N = 23 in A and B due to 3 missing data for plasma insulin, N = 26 subjects in C. Pearson correlations were used. D0: Day 0; M4: Month 4.</p