| Trial Information |
Trial description |
25/04/2024 |
it's a response to reviewers comments |
Spinal cord injury, whether of traumatic or non-traumatic origin, complete or incomplete, is a real burden affecting the patient himself, his family and society. The global incidence of spinal cord injury was estimated at 900,000 cases in 2019, which is lower than the data from 1990. However, the incidence in developing countries has increased, especially in North Africa and the Middle East (1). The management of spinal cord injury is based essentially on the management and improvement of symptoms secondary to the alteration of motor, sensory and organ function (2). Indeed, it is known that in spinal cord injury (SCI), there is an alteration of quality of life (QOL) that is more marked during the first year and that is not essentially related to the restriction of mobility but rather related to pain and secondary complications such as transit disorders and autonomic dysreflexia (3). Spinal cord injury causes an alteration of gastrointestinal function by the loss of sympathetic control of the stomach, small intestine and colon, which is associated with a disturbance of the intestinal microbiota (IM) (2). The intestinal microbiota is a set of microorganisms but mainly bacteria whose number is 10 times higher than the number of cells in the human body and that the sum of their genes is 100 times higher than the human genome. They then exert several physiological functions and are involved in some digestive and extra-digestive pathologies (4). The physiological functions of the intestinal microbiota are essentially trophic, metabolic and immune functions. Regarding the trophic role, the IM is involved in nutrition mainly through the synthesis of butyrate, the formation of epithelial cells and the stimulation of the synthesis of mucins that play a role of protection of the intestinal epithelium against pathogens. Among its metabolic functions, the IM has a role of digestion (mainly that of amino acids), the production of vitamins B, K and short-chain fatty acids, the abs |
Spinal cord injury (SCI), whether traumatic or non-traumatic, complete or incomplete, significantly burdens patients, their families, and society. Management primarily focuses on controlling and improving symptoms arising from impaired motor, sensory, and organ function. SCI is known to negatively impact quality of life (QOL), especially during the first year, due to pain and secondary complications like digestive issues and autonomic dysreflexia.
SCI disrupts gastrointestinal function due to the loss of sympathetic control of the stomach, small intestine, and colon, leading to an imbalance in the gut microbiota (gut bacteria). This imbalance, called "intestinal dysbiosis," is considered a comorbidity in SCI and contributes to other complications such as impaired immune function, neurocognitive function, mood, and metabolism, further worsening overall function and QOL.
Probiotics are live microorganisms that offer health benefits when administered properly. Certain probiotics have been used to treat gastrointestinal disorders like irritable bowel syndrome. Recent studies show promise for probiotics in improving QOL and gut function in SCI patients, possibly by influencing the central nervous system and impacting the gut microbiota. However, no published study has been done in Tunisia. Hence the interest of our study which aims to evaluate the effect of probiotics on the metabolic and nutritional status as well as the quality of life in spinal cord injury. |
| Outcome |
OutCome List |
25/04/2024 |
it's a response to reviewers comments |
Primary Outcome, Our primary endpoint is the improvement of the Neurological Bowel Dysfunction Score (NBD score)., 2 months |
Primary Outcome, Our primary endpoint is the improvement of the Neurological Bowel Dysfunction Score (NBD score)., just before intervention and at the end of the intervention. The duration of intervention is 2 months |