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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
PACTR
Registry ID
PACTR202405750001803
Enrollment
50
Registered
2024-05-02
Start date
2024-06-02
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive System Haematological Disorders Mental and Behavioural Disorders Nervous System Diseases Nutritional, Metabolic, Endocrine

Interventions

Probiotic Effect
Probiotic effect

Sponsors

Research Laboratory LR19ES09
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Our primary endpoint is the improvement of the Neurological Bowel Dysfunction Score (NBD score).

Secondary

MeasureTime frame
- Quality of life assessment: SF-36 - The Hospital Anxiety and Depression Scale (HADS) - Biological data: CBC, inflammatory profile, nutritional profile, lipid profile, fasting blood glucose

Countries

Tunisia

Contacts

Public ContactBassem Tiss

Physical Medicine and Rehabilitation

ettisbassem@gmail.com+216276402

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026