Effect of probiotics on quality of life and nutritional status in spinal cord injury: A controlled, randomized, double-blind study

Phase 3

Recruiting

• Conditions: Digestive System; Haematological Disorders; Mental and Behavioural Disorders; Nervous System Diseases; Nutritional, Metabolic, Endocrine

• Registration Number: PACTR202405750001803
• Lead Sponsor: Research Laboratory LR19ES09

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-15
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Age over 18 years
Presence of a spinal cord injury whether complete or incomplete, of traumatic or non-traumatic origin
Evolution of spinal cord injury greater than 1 year

Exclusion Criteria

Infection requiring prolonged antibiotic therapy Chronic digestive diseases or history of digestive surgery Paraplegics already followed in psychiatry
Pregnant or breastfeeding woman
Intolerance to the probiotic used Irregular intake of treatment
Intercurrent infection requiring antibiotic therapy
Lost to follow-up during the intervention

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Our primary endpoint is the improvement of the Neurological Bowel Dysfunction Score (NBD score).

Secondary Outcome Measures

Name	Time	Method
- Quality of life assessment: SF-36<br>- The Hospital Anxiety and Depression Scale (HADS)<br>- Biological data: CBC, inflammatory profile, nutritional profile, lipid profile, fasting blood glucose<br>