Evaluation Of The Effect Of L. Casei DG® On Vitamin D Absorption In Patients Under Vitamin D Supplementation.

NCT ID: NCT05394207

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2024-06-30

Brief Summary

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

Detailed Description

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.

Conditions

Vitamin D Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

GROUP 1 (Investigational product)

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.

Group Type: EXPERIMENTAL

L. casei DG® (Lactobacillus paracasei CNCM I-1572)

Intervention Type: DIETARY_SUPPLEMENT

L. casei DG® (Lactobacillus paracasei CNCM I-1572) containing 8 billion of live cells daily + Vitamin D 4.000 U.I. daily.

GROUP 2 (Comparator)

23 patients The comparator product is an identical matching placebo daily + Vitamin D 4.000 U.I. daily.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

The comparator product is an identical matching placebo daily + Vitamin D 4.000 U.I. daily.

Interventions

L. casei DG® (Lactobacillus paracasei CNCM I-1572)

L. casei DG® (Lactobacillus paracasei CNCM I-1572) containing 8 billion of live cells daily + Vitamin D 4.000 U.I. daily.

Intervention Type: DIETARY_SUPPLEMENT

placebo

The comparator product is an identical matching placebo daily + Vitamin D 4.000 U.I. daily.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Male and female adults aged ≥ 18 and ≤ 60 years;

2. Middle East Area residency;

3. Serum levels of Vit. D≤ 20 ng/ml at screening, for which a course of Vitamin D at a dose of 4.000 U.I. daily has been prescribed as per clinical practice;

4. Body Mass Index (BMI) between 18,50 and 29,99;

5. Acceptance of the study by the patient and written informed consent to participate in the study provided.

Exclusion Criteria

1. Serum level of Vit. D > 20ng/ml;

2. Documented malabsorption of Vit. D and/or other oligoelements and vitamins;

3. BMI ≤ 18.5 and ≥29,99;

4. Hypersensitivity to cholecalciferol or to any of the excipients of the prescribed drug;

5. Contraindications to Vit. D supplementation (e.g. hypercalcemia, hypercalciuria, renal failure);

6. Vit. D therapy or prophylaxis within 30 days before the enrolment in this study;

7. History of administration of systemic antibiotics or antibiotics at bowel action (es: rifaximin) within 30 days before the enrolment in this study;

8. History of administration of probiotics, prebiotics, (including probiotic/prebiotic enriched foods) within 30 days before the enrolment in this study;

9. Present treatment with Proton Pump Inhibitors (PPIs) and aluminium-containing antacids;

10. Present treatment with drugs interfering on the absorption of Vit. D, as barbiturates, antiepileptics (i.e. phenobarbital, phenytoin, carbamazepine), corticosteroids, antimycotics (i.e. ketoconazole, fluconazole), anti-retroviral agents, cholestyramine, colestipol, orlistat;

11. Patients with certain or suspected diagnosis of chronic inflammatory bowel diseases, cystic fibrosis or mucoviscidosis;

12. Patients with hepatic impairment (Alanine transaminase (ALT) or Aspartate aminotransferase (AST)>3 times the upper limit of normal);

13. Patients with nephrolithiasis or nephrocalcinosis;

14. Infective gastro-intestinal syndromes in active phase or gastro-intestinal infectious residue which can alter the bowel absorption on the judgement of the investigator;

15. Episodes of viral or bacterial enteritis within 2 months before the enrolment in the study;

16. History or presence of gastric and/or duodenal ulcers;

17. Psychiatric syndromes and/or psychological disturbances;

18. Any severe pathology which could interfere with the study treatment;

19. Presence of any relevant severe condition or clinically relevant abnormal laboratory parameters that in the opinion of the investigator may interfere with the participation to the study;

20. Poor reliability or presence of conditions leading to a poor compliance/adherence to the protocol by the patient;

21. Active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrolment are also acceptable);

22. Pregnancy and/or breastfeeding*;

23. Existence of mental illness or any mental condition potentially interfering with appropriate compliance with protocol procedures;

24. Patients without self-judgement ability;

25. Participation in another investigational study or treatment with any investigational drug within the previous 30 days;

26. Recent history or suspicion of alcohol abuse or drug addiction;

27. Patients not compliant with the procedures of the protocol.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SOFAR S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rashid Hospital

Dubai, , United Arab Emirates

Countries

United Arab Emirates

Central Contacts

Silvia Porta

Role: CONTACT

silvia.porta@sofarfarm.it

+39 02909362 1

Laura Patrucco

Role: CONTACT

laura.patrucco@sofarfarm.it

+39 02909362 1

Facility Contacts

Dr.Sameer Al Awadhi, Dr

Role: primary

saalawadhi@dha.gov.ae

+9714 219 1144

Other Identifiers

PSC-DS LacD3

Identifier Type: -

Identifier Source: org_study_id