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van CCT (UK)

van CCT (UK)

Effect of probiotics on bowel management in SCI

- candidate number24240
- NTR NumberNTR5831
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-apr-2016
- Secondary IDsABR57438 
- Public TitleEffect of probiotics on bowel management in SCI
- Scientific TitleEffect of a multispecies probiotic on bowel management in patients with spinal cord injury after use of antibiotics
- hypothesisIn this double-blind randomized placebo-controlled trial, we hypothesize to observe a reduced incidence of antibiotic associated diarrhae (AAD) in inpatients with a spinal cord injury (SCI) during the intake of probiotics, in comparison to a placebo, when antibiotic treatment is provided.
- Healt Condition(s) or Problem(s) studiedSpinal Cord Injury, Incontinence, Diarrhea, Fecal incontinence, Antibiotics, Probiotics
- Inclusion criteria- Confirmed diagnosis of SCI
- First admission to a rehabilitation center after the occurrence of SCI.
- Age between 18-75 years
- Requiring treatment with antibiotics
- Exclusion criteria- Known gastro-intestinal diseases
- Abdominal surgery within a year prior to study
- (Previous) radiotherapy or chemotherapy
- Severe auto immune diseases such as SLE and Sjogren
- Patients suffering from severe acute pancreatitis, multiple organ failure (MOF) or sepsis
- Patients receiving enteral feeding with the exception of nasogastric feeding
- Excessive alcohol intake (> 15 consumptions per week)
- (Planned) pregnancy or lactation
- Use of pre-, probiotics in the month before and during the study
- Use of antibiotics in the two weeks before the study
- More than one antibiotic treatment in the 6 month prior to the study.
- Previous participation in this study design
- Duration of antibiotics use longer than 14 days
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2016
- planned closingdate1-dec-2018
- Target number of participants40
- InterventionsParticipants will be randomly assigned to receive both an antibiotic treatment and Ecologic® AAD, or an antibiotic treatment and a placebo. Subjects will receive either probiotic or placebo for 26-31 days (depending on the length of antibiotic treatment; 5-10 days); starting together with the antibiotic treatment and ending three weeks after cessation.
- Primary outcomeIncidence of faecal incontinence, defined by frequency, consistency, (un)wanted defecation, measured by the Bristol Stool Scale.
- Secondary outcomeQuality of life, nausea.
- TimepointsT0 = start of intervention: start use of antibiotics together with probiotics or the placebo
T1 = last day of use of antibiotics (between 5 and 10 days after T0)
T2 = last day of use of probiotics (2 weeks after T1)
T3 = end of follow-up period (2 weeks after T2)
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Heliomare Rehabiliation Wijk aan Zee, Reade Center for Rehabilitation and Rheumatology
- Funding
(Source(s) of Monetary or Material Support)
Heliomare Rehabiliation Wijk aan Zee, Winclove Bio Industries B.V.
- Publications
- Brief summaryAntibiotic-associated diarrhea is a common complication in antibiotic use in patients with a spinal cord injury. Diarrhea primarily leads to feelings of general discomfort and, as as a result, patients might be delayed in their rehabilitation after spinal cord injury. The objective of this study is to investigate whether the use of probiotics can decrease faecal incontinence and positively influence the bowel management regimen in inpatients with a spinal cord injury treated with antibiotics. The use of probiotics will be double-blind controlled with a placebo. The primary outcome that will be compared between the intervention and placebo group is the incidence of faecal incontinence, defined by frequency, consistency, and (un)wanted defecation. Secondary outcome measures are quality of life and nausea.
- Main changes (audit trail)
- RECORD15-apr-2016 - 5-mrt-2017

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