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Study protocol of a double-blind randomised placebo-controlled trial on the effect of a multispecies probiotic on the incidence of antibiotic-associated diarrhoea in persons with spinal cord injury.
Faber, W X M; Nachtegaal, J; Stolwijk-Swuste, J M; Achterberg-Warmer, W J; Koning, C J M; Besseling-van der Vaart, I; van Bennekom, C A M.
Afiliación
  • Faber WXM; Heliomare Rehabilitation Center, Wijk aan Zee, The Netherlands. w.faber@heliomare.nl.
  • Nachtegaal J; Department of Research & Development, Heliomare Rehabilitation Center, Wijk aan Zee, The Netherlands.
  • Stolwijk-Swuste JM; Center of Excellence for Rehabilitation Medicine, Brain Center Rudolf Magnus, University Medical Center Utrecht and De Hoogstraat Rehabilitation, Utrecht University, Utrecht, the Netherlands.
  • Achterberg-Warmer WJ; Amsterdam Rehabilitation Research Center, Reade, the Netherlands.
  • Koning CJM; Winclove Probiotics B.V, Amsterdam, The Netherlands.
  • Besseling-van der Vaart I; Winclove Probiotics B.V, Amsterdam, The Netherlands.
  • van Bennekom CAM; Heliomare Rehabilitation Center, Wijk aan Zee, The Netherlands.
Spinal Cord ; 58(2): 149-156, 2020 Feb.
Article en En | MEDLINE | ID: mdl-31712614
STUDY DESIGN: Multi-centre, double-blind randomised placebo-controlled study. OBJECTIVE: To investigate whether the use of a multispecies probiotic can prevent antibiotic-associated diarrhoea in people with spinal cord injury (SCI). SETTING: Three Dutch SCI rehabilitation centres. METHODS: Fifty-six people aged 18-75 years with SCI during inpatient rehabilitation, who require antibiotics, will be given probiotics or placebo randomly assigned (T0). After cessation of the antibiotics (T1), the participants will use probiotics/placebo for 3 more weeks (T2). Defaecation, assessed by the Bristol Stool Scale, and bowel management will be monitored daily until 2 weeks after cessation of probiotics/placebo intake (T3). Also, the degree of nausea and information on quality of life will be collected at T0, T1, T2 and T3. MAIN OUTCOME MEASURES: The difference between the incidence of antibiotic-associated diarrhoea between people with SCI using probiotics compared to those using a placebo at the moment the antibiotics stops, the probiotics stops and two weeks thereafter. SECONDARY OUTCOME MEASURES: The time to reach effective bowel management, degree of nausea and quality of life. REGISTRATION: The Dutch Trial Register- NTR 5831.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Traumatismos de la Médula Espinal / Evaluación de Resultado en la Atención de Salud / Probióticos / Diarrea / Infecciones / Antibacterianos Tipo de estudio: Clinical_trials / Incidence_studies / Risk_factors_studies Aspecto: Patient_preference Límite: Adolescent / Adult / Aged / Humans / Middle aged Idioma: En Revista: Spinal Cord Asunto de la revista: NEUROLOGIA Año: 2020 Tipo del documento: Article País de afiliación: Países Bajos Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Traumatismos de la Médula Espinal / Evaluación de Resultado en la Atención de Salud / Probióticos / Diarrea / Infecciones / Antibacterianos Tipo de estudio: Clinical_trials / Incidence_studies / Risk_factors_studies Aspecto: Patient_preference Límite: Adolescent / Adult / Aged / Humans / Middle aged Idioma: En Revista: Spinal Cord Asunto de la revista: NEUROLOGIA Año: 2020 Tipo del documento: Article País de afiliación: Países Bajos Pais de publicación: Reino Unido