An interventional study of L. casei DG® (Lactobacillus paracasei CNCM I-1572) and placebo in Vitamin D Deficiency, sponsored by SOFAR S.p.A.. Status unknown at 1 site in United Arab Emirates. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-04-12.
Sponsored by SOFAR S.p.A. · Not applicable, Interventional, and Treatment
Vitamin D deficiency is one of the most underdiagnosed and undertreated medical condition worldwide . The microbiome and vitamin D deeply influence each other and the immune system in many different ways. It is evident that the immune system and the microbiome are interconnected, and that vitamin D is a critical intermediary player in this dynamic .
Probiotics were shown to increase vitamin D intestinal absorption and increase vitamin D receptor protein expression and transcriptional activity . Likewise, vitamin D receptor status seems to be crucial in regulating the mechanisms of action of probiotics and modulating their anti-inflammatory, immunomodulatory and anti-infective benefits, suggesting a two-sided pathway . The objective of this study is to assess the different absorption of Vitamin D (Vit. D) between patients treated with Vit. D supplementation combined to a probiotic containing L. casei DG® and patients treated with Vitamin D supplementation and placebo
The present study is a monocentric, exploratory, randomized, double-blind, controlled study to evaluate the effects of daily intake of L. Casei DG® (L. Paracasei CNCM I1572) on vitamin D absorption in adult patients with Vitamin D (Vit. D) deficiency, defined as a blood level of 25(OH) D ≤ 20 ng/ml.
The investigational product is ENTEROLACTIS®, a food supplement resulting from SOFAR research (listed in the Food Supplement Registry of the United Arab Emirates Ministry of Health \& Prevention with the code #12235-13911-2) available as drinkable vials of 10 ml, containing 8 billion of live cells of L. casei DG The comparator product is an identical drinkable vial of placebo. Vit. D will be provided by the sponsor as oral drops of 10. 000 U.I./mL 16 drops of Vit. D must be dissolved in the Investigational Product/placebo vial and then this has to be reconstituted and drunk immediately.
The patients will be involved in 10 on site visits: V-1 (Screening)- within 7 days before baseline visit, V0 (Baseline) at the start of therapy, V1- 1 week after the start of therapy, 6 visits (V2-V7) every two weeks and V8- follow up visit, 4 weeks after the end of treatment (EOT-V7).
Investigational Product/comparator treatment will start at V0 and will end at V7, for a duration of 12 weeks. After the End of Treatment visit (EOT-V7), patients will enter in a 4 weeks Follow Up (FU) period, for a total duration of the study of 16 weeks (12 weeks of treatment + 4 weeks of FUP). If a patient reaches normal levels of Vitamin D before EOT visit, study treatment will be interrupted, and patient will enter the FU period.
Exclusion Criteria:
23 patients Investigational product: L. casei DG® (Lactobacillus paracasei CNCM I-1572) containing 8 billion of live cells daily + Vitamin D 4.000 U.I. daily.
Dietary Supplement: L. casei DG® (Lactobacillus paracasei CNCM I-1572)
23 patients The comparator product is an identical matching placebo daily + Vitamin D 4.000 U.I. daily.
Other: placebo
L. casei DG® (Lactobacillus paracasei CNCM I-1572) containing 8 billion of live cells daily + Vitamin D 4.000 U.I. daily.
The comparator product is an identical matching placebo daily + Vitamin D 4.000 U.I. daily.
Serum levels of vitamin D (25-hydroxyvitamin D- 25(OH) D) measured in ng/mL
Modification of the serum level of Vit. D in patients treated with L. casei DG® plus Vitamin D compared to the group treated with Vitamin D plus placebo will be measured in ng/mL
Time frame: week 12
Time to reach normal serum levels of Vit. D.
Serum levels of vitamin D (25-hydroxyvitamin D- 25(OH) D) will be measured in ng/mL.
Time frame: week 12
Presence of L. casei DG® strain in faeces
Presence of L. casei DG® strain in faeceswill be assessed by real time quantitative PCR (qPCR).
Time frame: week 12
Modification from baseline of faecal microbiota in terms of indices of microbial α diversity
Alpha-diversity will be measured by Shannon and Chao1 indexes
Time frame: week 12
Modification from baseline of faecal microbiota in terms of indices of microbial β diversity
Beta-diversity will be analyzed with the UniFrac algorithms and plotted applying non-metric multidimensional scaling (NMDS)
Time frame: week 12
Modification from baseline of faecal microbiota in terms of indices of microbial relative taxonomic abundance
The relative abundance of microbial taxa will be evaluated descriptively and graphically by treatment groups and by study visits to show the phyla, orders, genera and operational taxonomic units (OTUs) most commonly detected in the collected samples.
Time frame: week 12
Modification from baseline of faecal short-chain fatty acid (SCFAs);
measurement of fecal levels (mmol/100g) of: lactate, acetate, succinate, propionate,butyrate,valerate, iso-valerate.
Time frame: week 12
Modification of serum levels of Interleukin 6 (IL-6), Interleukin 8 (IL-8), Interleukin 10 (IL-10)
serum levels of Interleukin 6 (IL-6), Interleukin 8 (IL-8), Interleukin 10 (IL-10) will be measured in pg/mL
Time frame: week 12
Modification of serum levels of C reactive protein (CRP)
serum levels of C reactive protein (CRP) will be measured in mg/mL
Time frame: week 12
Modification of serum levels of zonulin
serum levels of zonulin measured in ng/mL;
Time frame: week 12
Modification of serum levels of total cholesterol, LDL, HDL and triglycerides
serum levels of total cholesterol, LDL, HDL and triglycerides measured in mg/dL
Time frame: week 12
Evaluate the overall patient satisfaction with treatment
Evaluate the overall satisfaction with treatment by means of Visual Analogue Scale (VAS) scale at V7. 10 cm scale where 0 not satisfied at all is and 10 is fully satisfied
Time frame: week 12
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events assessed by the diary dispensed to patients at V0.
Time frame: week 16
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SOFAR S.p.A.